SPL Mapping FHIR R5 Implementation Guide
0.2.1 - Build CI United States of America flag

SPL Mapping FHIR R5 Implementation Guide, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 0.2.1 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/fhir-spl/ and changes regularly. See the Directory of published versions

Logical Model: SubmittedMedicationLogicalModel - Detailed Descriptions

Page standards status: Trial-use Maturity Level: 1

Definitions for the SubmittedMedicationLogicalModel logical model.

Guidance on how to interpret the contents of this table can be found here

0. SubmittedMedication
Definition

Details about the Medication that is submitted to the FDA.

ShortSubmitted Medication Logical Model
Logical ModelInstances of this logical model are not marked to be the target of a Reference
2. SubmittedMedication.ndcCode
Definition

The NDC Code that uniquely identifies this medication.

ShortNDC Code
Control0..1
TypeCodeableConcept
4. SubmittedMedication.proprietaryName
Definition

The name of the Medication as used in medication labeling or in a catalog.

ShortProprietary Name
Control1..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
6. SubmittedMedication.proprietaryNameSuffix
Definition

An optional suffix that is part of the proprietary name.

ShortProprietary Name Suffix
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
8. SubmittedMedication.nonProprietaryName
Definition

An optional name of the medication that is used to refer to this medication.

ShortNon-Proprietary Name
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
10. SubmittedMedication.form
Definition

A code that indicates the dose form of the medication.

ShortMedication Form
Control0..1
TypeCodeableConcept
12. SubmittedMedication.sourceMedicationCode
Definition

An NDC code that indicates a medication that is the source of this medication.

ShortSource Medication
Control0..1
TypeCodeableConcept
14. SubmittedMedication.MedicationIdentifier
Definition

Additional identifiers that are customer facing and can be used to refer to this medication.

ShortAdditional Identifiers
Control0..*
TypeIdentifier
16. SubmittedMedication.deaSchedule
Definition

A code that indicates the specific DEA schedule that this medication belongs to.

ShortDEA Schedule Code
Control0..1
TypeCodeableConcept
18. SubmittedMedication.route
Definition

A code that indicates the route by which the medication is administered.

ShortRoute of Administration
Control0..*
TypeCodeableConcept
20. SubmittedMedication.ingredient
Definition

Ingredient information for this medication.

ShortMedication Ingredients
Control0..*
TypeBackboneElement
22. SubmittedMedication.ingredient.type
Definition

A code that indicates the role the ingredient has in this medication, eg. active, flavouring, base, etc.

ShortIngredient Type
Control1..1
Typecode
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
24. SubmittedMedication.ingredient.unii
Definition

The UNII that identifies the ingredient substance.

ShortIngredient Code
Control1..1
TypeCodeableConcept
26. SubmittedMedication.ingredient.name
Definition

The name of the ingredient.

ShortIngredient Name
Control1..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
28. SubmittedMedication.ingredient.strength
Definition

How much of the ingredient is present in the medication.

ShortIngredient Strength
Control0..1
TypeRatio
30. SubmittedMedication.ingredient.activeMoiety
Definition

The active moeity that corresponds to this ingredient.

ShortIngredient Active Moiety
Control1..2
TypeBackboneElement
32. SubmittedMedication.ingredient.activeMoiety.unii
Definition

The UNII that identifies the ingredient's active moiety.

ShortActive Moiety Code
Control1..1
TypeCodeableConcept
34. SubmittedMedication.ingredient.activeMoiety.name
Definition

The name of the ingredient's active moiety.

ShortActive Moiety Name
Control1..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
36. SubmittedMedication.ingredient.strengthReference
Definition

An ingredient that is used as the reference for the strength.

ShortReference Ingredient for Strength
Control0..1
TypeBackboneElement
38. SubmittedMedication.ingredient.strengthReference.unii
Definition

The UNII that identifies the reference ingredient.

ShortReference Ingredient Code
Control1..1
TypeCodeableConcept
40. SubmittedMedication.ingredient.strengthReference.name
Definition

The name of the reference ingredient.

ShortReference Ingredient Name
Control1..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
42. SubmittedMedication.packaging
Definition

Information about the various packaging of the medication.

ShortMedication Packaging
Control0..1
TypeBackboneElement
44. SubmittedMedication.packaging.quantity
Definition

Amount of medication in the package.

ShortAmount of medication in the package.
Control1..1
TypeQuantity
46. SubmittedMedication.packaging.type
Definition

The type of the packaging.

ShortPackaging Type
Control1..1
TypeCodeableConcept
48. SubmittedMedication.packaging.code
Definition

The NDC package code that corresponds to this packaging.

ShortPackaging Identifier
Control0..1
TypeCodeableConcept
50. SubmittedMedication.packaging.sample
Definition

Indicates whether the package is a drug sample.

ShortDrug Sample Flag
Control1..1
Typeboolean
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
52. SubmittedMedication.packaging.combinationMedicationType
Definition

Indicates the type of combination medication, if applicable.

ShortCombination Medication Type
Control0..1
TypeCodeableConcept
54. SubmittedMedication.packaging.marketingStatusPeriod
Definition

The start and end date of when this package is on the market.

ShortMarketing Status Period
Control0..1
TypePeriod
56. SubmittedMedication.packaging.characteristic
Definition

Properties that provide extra information about the packaging.

ShortPackaging Characteristics
Control0..*
TypeSeettp://hl7.org/fhir/us/spl/StructureDefinition/SubmittedMedicationLogicalModel#SubmittedMedication.characteristic
58. SubmittedMedication.packaging.packaging
Definition

Packaging that contains this package.

ShortOuter Packaging
Control0..1
TypeSeettp://hl7.org/fhir/us/spl/StructureDefinition/SubmittedMedicationLogicalModel#SubmittedMedication.packaging
60. SubmittedMedication.part
Definition

Information about parts of the medication.

ShortMedication Part
Control0..*
TypeBackboneElement
62. SubmittedMedication.part.quantity
Definition

Amount of parts in the medication.

ShortPart Quantity
Control1..1
TypeQuantity
64. SubmittedMedication.part.Medication
Definition

Medication information for this part.

ShortPart Medication
Control1..1
TypeReference(Submitted Medication Logical Model)
66. SubmittedMedication.part.marketing
Definition

Marketing Information about this part.

ShortPart Marketing
Control0..1
TypeSeettp://hl7.org/fhir/us/spl/StructureDefinition/SubmittedMedicationLogicalModel#SubmittedMedication.marketing
68. SubmittedMedication.marketing
Definition

Information about the marketing category and an associated application.

ShortMarketing Application Information
Control0..1
TypeBackboneElement
70. SubmittedMedication.marketing.number
Definition

The application number for this medication.

ShortMarkting Application Number
Control0..1
TypeIdentifier
72. SubmittedMedication.marketing.category
Definition

The marketing category for this medication.

ShortMarketing Category
Control0..1
TypeCodeableConcept
74. SubmittedMedication.marketing.approvalDate
Definition

The approval date of the marketing applicaiton.

ShortMarketing Approval Date
Control0..1
TypedateTime
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
76. SubmittedMedication.marketingStatusPeriod
Definition

The start and end date of when the medication is on the market.

ShortMarketing Status Period
Control1..1
TypePeriod
78. SubmittedMedication.characteristic
Definition

Properties that provide extra information about the medication.

ShortMedication Characteristics
Control0..*
TypeBackboneElement
80. SubmittedMedication.characteristic.type
Definition

A code that identifies the characteristic.

ShortCharacteristic Type
Control1..1
TypeCodeableConcept
82. SubmittedMedication.characteristic.value[x]
Definition

The value of the characteristic.

ShortCharacteristic Value
Control1..1
TypeChoice of: Quantity, integer, Range, CodeableConcept, string, base64Binary, boolean
[x] NoteSeeChoice of Data Typesfor further information about how to use [x]
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension

Guidance on how to interpret the contents of this table can be found here

0. SubmittedMedication
Definition

Details about the Medication that is submitted to the FDA.


Base definition for all elements in a resource.

ShortSubmitted Medication Logical ModelBase for all elements
Control0..*
Is Modifierfalse
Logical ModelInstances of this logical model are not marked to be the target of a Reference
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
2. SubmittedMedication.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
This element is affected by the following invariants: ele-1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
4. SubmittedMedication.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on SubmittedMedication.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
  • value @ url
  • 6. SubmittedMedication.ndcCode
    Definition

    The NDC Code that uniquely identifies this medication.

    ShortNDC Code
    Control0..1
    TypeCodeableConcept
    8. SubmittedMedication.proprietaryName
    Definition

    The name of the Medication as used in medication labeling or in a catalog.

    ShortProprietary Name
    Control1..1
    Typestring
    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
    10. SubmittedMedication.proprietaryNameSuffix
    Definition

    An optional suffix that is part of the proprietary name.

    ShortProprietary Name Suffix
    Control0..1
    Typestring
    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
    12. SubmittedMedication.nonProprietaryName
    Definition

    An optional name of the medication that is used to refer to this medication.

    ShortNon-Proprietary Name
    Control0..1
    Typestring
    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
    14. SubmittedMedication.form
    Definition

    A code that indicates the dose form of the medication.

    ShortMedication Form
    Control0..1
    TypeCodeableConcept
    16. SubmittedMedication.sourceMedicationCode
    Definition

    An NDC code that indicates a medication that is the source of this medication.

    ShortSource Medication
    Control0..1
    TypeCodeableConcept
    18. SubmittedMedication.MedicationIdentifier
    Definition

    Additional identifiers that are customer facing and can be used to refer to this medication.

    ShortAdditional Identifiers
    Control0..*
    TypeIdentifier
    20. SubmittedMedication.deaSchedule
    Definition

    A code that indicates the specific DEA schedule that this medication belongs to.

    ShortDEA Schedule Code
    Control0..1
    TypeCodeableConcept
    22. SubmittedMedication.route
    Definition

    A code that indicates the route by which the medication is administered.

    ShortRoute of Administration
    Control0..*
    TypeCodeableConcept
    24. SubmittedMedication.ingredient
    Definition

    Ingredient information for this medication.

    ShortMedication Ingredients
    Control0..*
    TypeBackboneElement
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    26. SubmittedMedication.ingredient.id
    Definition

    Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

    ShortUnique id for inter-element referencing
    Control0..1
    This element is affected by the following invariants: ele-1
    Typeidstring
    Is Modifierfalse
    XML FormatIn the XML format, this property is represented as an attribute.
    Summaryfalse
    28. SubmittedMedication.ingredient.extension
    Definition

    May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

    ShortAdditional content defined by implementations
    Comments

    There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

    Control0..*
    TypeExtension
    Is Modifierfalse
    Summaryfalse
    Alternate Namesextensions, user content
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
    SlicingThis element introduces a set of slices on SubmittedMedication.ingredient.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
    • value @ url
    • 30. SubmittedMedication.ingredient.modifierExtension
      Definition

      May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

      Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

      ShortExtensions that cannot be ignored even if unrecognized
      Comments

      There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

      Control0..*
      TypeExtension
      Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
      Summarytrue
      Requirements

      Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

      Alternate Namesextensions, user content, modifiers
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
      32. SubmittedMedication.ingredient.type
      Definition

      A code that indicates the role the ingredient has in this medication, eg. active, flavouring, base, etc.

      ShortIngredient Type
      Control1..1
      Typecode
      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
      34. SubmittedMedication.ingredient.unii
      Definition

      The UNII that identifies the ingredient substance.

      ShortIngredient Code
      Control1..1
      TypeCodeableConcept
      36. SubmittedMedication.ingredient.name
      Definition

      The name of the ingredient.

      ShortIngredient Name
      Control1..1
      Typestring
      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
      38. SubmittedMedication.ingredient.strength
      Definition

      How much of the ingredient is present in the medication.

      ShortIngredient Strength
      Control0..1
      TypeRatio
      40. SubmittedMedication.ingredient.activeMoiety
      Definition

      The active moeity that corresponds to this ingredient.

      ShortIngredient Active Moiety
      Control1..2
      TypeBackboneElement
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      42. SubmittedMedication.ingredient.activeMoiety.id
      Definition

      Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

      ShortUnique id for inter-element referencing
      Control0..1
      This element is affected by the following invariants: ele-1
      Typeidstring
      Is Modifierfalse
      XML FormatIn the XML format, this property is represented as an attribute.
      Summaryfalse
      44. SubmittedMedication.ingredient.activeMoiety.extension
      Definition

      May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

      ShortAdditional content defined by implementations
      Comments

      There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

      Control0..*
      TypeExtension
      Is Modifierfalse
      Summaryfalse
      Alternate Namesextensions, user content
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
      SlicingThis element introduces a set of slices on SubmittedMedication.ingredient.activeMoiety.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
      • value @ url
      • 46. SubmittedMedication.ingredient.activeMoiety.modifierExtension
        Definition

        May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

        Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

        ShortExtensions that cannot be ignored even if unrecognized
        Comments

        There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

        Control0..*
        TypeExtension
        Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
        Summarytrue
        Requirements

        Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

        Alternate Namesextensions, user content, modifiers
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
        48. SubmittedMedication.ingredient.activeMoiety.unii
        Definition

        The UNII that identifies the ingredient's active moiety.

        ShortActive Moiety Code
        Control1..1
        TypeCodeableConcept
        50. SubmittedMedication.ingredient.activeMoiety.name
        Definition

        The name of the ingredient's active moiety.

        ShortActive Moiety Name
        Control1..1
        Typestring
        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
        52. SubmittedMedication.ingredient.strengthReference
        Definition

        An ingredient that is used as the reference for the strength.

        ShortReference Ingredient for Strength
        Control0..1
        TypeBackboneElement
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        54. SubmittedMedication.ingredient.strengthReference.id
        Definition

        Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

        ShortUnique id for inter-element referencing
        Control0..1
        This element is affected by the following invariants: ele-1
        Typeidstring
        Is Modifierfalse
        XML FormatIn the XML format, this property is represented as an attribute.
        Summaryfalse
        56. SubmittedMedication.ingredient.strengthReference.extension
        Definition

        May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

        ShortAdditional content defined by implementations
        Comments

        There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

        Control0..*
        TypeExtension
        Is Modifierfalse
        Summaryfalse
        Alternate Namesextensions, user content
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
        SlicingThis element introduces a set of slices on SubmittedMedication.ingredient.strengthReference.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
        • value @ url
        • 58. SubmittedMedication.ingredient.strengthReference.modifierExtension
          Definition

          May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

          Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

          ShortExtensions that cannot be ignored even if unrecognized
          Comments

          There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

          Control0..*
          TypeExtension
          Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
          Summarytrue
          Requirements

          Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

          Alternate Namesextensions, user content, modifiers
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
          60. SubmittedMedication.ingredient.strengthReference.unii
          Definition

          The UNII that identifies the reference ingredient.

          ShortReference Ingredient Code
          Control1..1
          TypeCodeableConcept
          62. SubmittedMedication.ingredient.strengthReference.name
          Definition

          The name of the reference ingredient.

          ShortReference Ingredient Name
          Control1..1
          Typestring
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          64. SubmittedMedication.packaging
          Definition

          Information about the various packaging of the medication.

          ShortMedication Packaging
          Control0..1
          TypeBackboneElement
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          66. SubmittedMedication.packaging.id
          Definition

          Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

          ShortUnique id for inter-element referencing
          Control0..1
          This element is affected by the following invariants: ele-1
          Typeidstring
          Is Modifierfalse
          XML FormatIn the XML format, this property is represented as an attribute.
          Summaryfalse
          68. SubmittedMedication.packaging.extension
          Definition

          May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

          ShortAdditional content defined by implementations
          Comments

          There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

          Control0..*
          TypeExtension
          Is Modifierfalse
          Summaryfalse
          Alternate Namesextensions, user content
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
          SlicingThis element introduces a set of slices on SubmittedMedication.packaging.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
          • value @ url
          • 70. SubmittedMedication.packaging.modifierExtension
            Definition

            May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

            Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

            ShortExtensions that cannot be ignored even if unrecognized
            Comments

            There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

            Control0..*
            TypeExtension
            Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
            Summarytrue
            Requirements

            Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

            Alternate Namesextensions, user content, modifiers
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
            72. SubmittedMedication.packaging.quantity
            Definition

            Amount of medication in the package.

            ShortAmount of medication in the package.
            Control1..1
            TypeQuantity
            74. SubmittedMedication.packaging.type
            Definition

            The type of the packaging.

            ShortPackaging Type
            Control1..1
            TypeCodeableConcept
            76. SubmittedMedication.packaging.code
            Definition

            The NDC package code that corresponds to this packaging.

            ShortPackaging Identifier
            Control0..1
            TypeCodeableConcept
            78. SubmittedMedication.packaging.sample
            Definition

            Indicates whether the package is a drug sample.

            ShortDrug Sample Flag
            Control1..1
            Typeboolean
            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
            80. SubmittedMedication.packaging.combinationMedicationType
            Definition

            Indicates the type of combination medication, if applicable.

            ShortCombination Medication Type
            Control0..1
            TypeCodeableConcept
            82. SubmittedMedication.packaging.marketingStatusPeriod
            Definition

            The start and end date of when this package is on the market.

            ShortMarketing Status Period
            Control0..1
            TypePeriod
            84. SubmittedMedication.packaging.characteristic
            Definition

            Properties that provide extra information about the packaging.

            ShortPackaging Characteristics
            Control0..*
            TypeSeettp://hl7.org/fhir/us/spl/StructureDefinition/SubmittedMedicationLogicalModel#SubmittedMedication.characteristic
            86. SubmittedMedication.packaging.packaging
            Definition

            Packaging that contains this package.

            ShortOuter Packaging
            Control0..1
            TypeSeettp://hl7.org/fhir/us/spl/StructureDefinition/SubmittedMedicationLogicalModel#SubmittedMedication.packaging
            88. SubmittedMedication.part
            Definition

            Information about parts of the medication.

            ShortMedication Part
            Control0..*
            TypeBackboneElement
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            90. SubmittedMedication.part.id
            Definition

            Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

            ShortUnique id for inter-element referencing
            Control0..1
            This element is affected by the following invariants: ele-1
            Typeidstring
            Is Modifierfalse
            XML FormatIn the XML format, this property is represented as an attribute.
            Summaryfalse
            92. SubmittedMedication.part.extension
            Definition

            May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

            ShortAdditional content defined by implementations
            Comments

            There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

            Control0..*
            TypeExtension
            Is Modifierfalse
            Summaryfalse
            Alternate Namesextensions, user content
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
            SlicingThis element introduces a set of slices on SubmittedMedication.part.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
            • value @ url
            • 94. SubmittedMedication.part.modifierExtension
              Definition

              May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

              Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

              ShortExtensions that cannot be ignored even if unrecognized
              Comments

              There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

              Control0..*
              TypeExtension
              Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
              Summarytrue
              Requirements

              Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

              Alternate Namesextensions, user content, modifiers
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
              96. SubmittedMedication.part.quantity
              Definition

              Amount of parts in the medication.

              ShortPart Quantity
              Control1..1
              TypeQuantity
              98. SubmittedMedication.part.Medication
              Definition

              Medication information for this part.

              ShortPart Medication
              Control1..1
              TypeReference(Submitted Medication Logical Model)
              100. SubmittedMedication.part.marketing
              Definition

              Marketing Information about this part.

              ShortPart Marketing
              Control0..1
              TypeSeettp://hl7.org/fhir/us/spl/StructureDefinition/SubmittedMedicationLogicalModel#SubmittedMedication.marketing
              102. SubmittedMedication.marketing
              Definition

              Information about the marketing category and an associated application.

              ShortMarketing Application Information
              Control0..1
              TypeBackboneElement
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              104. SubmittedMedication.marketing.id
              Definition

              Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

              ShortUnique id for inter-element referencing
              Control0..1
              This element is affected by the following invariants: ele-1
              Typeidstring
              Is Modifierfalse
              XML FormatIn the XML format, this property is represented as an attribute.
              Summaryfalse
              106. SubmittedMedication.marketing.extension
              Definition

              May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

              ShortAdditional content defined by implementations
              Comments

              There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

              Control0..*
              TypeExtension
              Is Modifierfalse
              Summaryfalse
              Alternate Namesextensions, user content
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
              SlicingThis element introduces a set of slices on SubmittedMedication.marketing.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
              • value @ url
              • 108. SubmittedMedication.marketing.modifierExtension
                Definition

                May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                ShortExtensions that cannot be ignored even if unrecognized
                Comments

                There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                Control0..*
                TypeExtension
                Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                Summarytrue
                Requirements

                Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                Alternate Namesextensions, user content, modifiers
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                110. SubmittedMedication.marketing.number
                Definition

                The application number for this medication.

                ShortMarkting Application Number
                Control0..1
                TypeIdentifier
                112. SubmittedMedication.marketing.category
                Definition

                The marketing category for this medication.

                ShortMarketing Category
                Control0..1
                TypeCodeableConcept
                114. SubmittedMedication.marketing.approvalDate
                Definition

                The approval date of the marketing applicaiton.

                ShortMarketing Approval Date
                Control0..1
                TypedateTime
                Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                116. SubmittedMedication.marketingStatusPeriod
                Definition

                The start and end date of when the medication is on the market.

                ShortMarketing Status Period
                Control1..1
                TypePeriod
                118. SubmittedMedication.characteristic
                Definition

                Properties that provide extra information about the medication.

                ShortMedication Characteristics
                Control0..*
                TypeBackboneElement
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                120. SubmittedMedication.characteristic.id
                Definition

                Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                ShortUnique id for inter-element referencing
                Control0..1
                This element is affected by the following invariants: ele-1
                Typeidstring
                Is Modifierfalse
                XML FormatIn the XML format, this property is represented as an attribute.
                Summaryfalse
                122. SubmittedMedication.characteristic.extension
                Definition

                May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                ShortAdditional content defined by implementations
                Comments

                There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                Control0..*
                TypeExtension
                Is Modifierfalse
                Summaryfalse
                Alternate Namesextensions, user content
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                SlicingThis element introduces a set of slices on SubmittedMedication.characteristic.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                • value @ url
                • 124. SubmittedMedication.characteristic.modifierExtension
                  Definition

                  May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                  Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                  ShortExtensions that cannot be ignored even if unrecognized
                  Comments

                  There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                  Control0..*
                  TypeExtension
                  Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                  Summarytrue
                  Requirements

                  Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                  Alternate Namesextensions, user content, modifiers
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                  126. SubmittedMedication.characteristic.type
                  Definition

                  A code that identifies the characteristic.

                  ShortCharacteristic Type
                  Control1..1
                  TypeCodeableConcept
                  128. SubmittedMedication.characteristic.value[x]
                  Definition

                  The value of the characteristic.

                  ShortCharacteristic Value
                  Control1..1
                  TypeChoice of: Quantity, integer, Range, CodeableConcept, string, base64Binary, boolean
                  [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                  Primitive ValueThis primitive element may be present, or absent, or replaced by an extension

                  Guidance on how to interpret the contents of this table can be found here

                  0. SubmittedMedication
                  Definition

                  Details about the Medication that is submitted to the FDA.

                  ShortSubmitted Medication Logical Model
                  Control0..*
                  Is Modifierfalse
                  Logical ModelInstances of this logical model are not marked to be the target of a Reference
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  2. SubmittedMedication.id
                  Definition

                  Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                  ShortUnique id for inter-element referencing
                  Control0..1
                  This element is affected by the following invariants: ele-1
                  Typestring
                  Is Modifierfalse
                  XML FormatIn the XML format, this property is represented as an attribute.
                  Summaryfalse
                  4. SubmittedMedication.extension
                  Definition

                  May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                  ShortAdditional content defined by implementations
                  Comments

                  There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                  Control0..*
                  TypeExtension
                  Is Modifierfalse
                  Summaryfalse
                  Alternate Namesextensions, user content
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                  SlicingThis element introduces a set of slices on SubmittedMedication.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                  • value @ url
                  • 6. SubmittedMedication.ndcCode
                    Definition

                    The NDC Code that uniquely identifies this medication.

                    ShortNDC Code
                    Control0..1
                    TypeCodeableConcept
                    8. SubmittedMedication.proprietaryName
                    Definition

                    The name of the Medication as used in medication labeling or in a catalog.

                    ShortProprietary Name
                    Control1..1
                    Typestring
                    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                    10. SubmittedMedication.proprietaryNameSuffix
                    Definition

                    An optional suffix that is part of the proprietary name.

                    ShortProprietary Name Suffix
                    Control0..1
                    Typestring
                    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                    12. SubmittedMedication.nonProprietaryName
                    Definition

                    An optional name of the medication that is used to refer to this medication.

                    ShortNon-Proprietary Name
                    Control0..1
                    Typestring
                    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                    14. SubmittedMedication.form
                    Definition

                    A code that indicates the dose form of the medication.

                    ShortMedication Form
                    Control0..1
                    TypeCodeableConcept
                    16. SubmittedMedication.sourceMedicationCode
                    Definition

                    An NDC code that indicates a medication that is the source of this medication.

                    ShortSource Medication
                    Control0..1
                    TypeCodeableConcept
                    18. SubmittedMedication.MedicationIdentifier
                    Definition

                    Additional identifiers that are customer facing and can be used to refer to this medication.

                    ShortAdditional Identifiers
                    Control0..*
                    TypeIdentifier
                    20. SubmittedMedication.deaSchedule
                    Definition

                    A code that indicates the specific DEA schedule that this medication belongs to.

                    ShortDEA Schedule Code
                    Control0..1
                    TypeCodeableConcept
                    22. SubmittedMedication.route
                    Definition

                    A code that indicates the route by which the medication is administered.

                    ShortRoute of Administration
                    Control0..*
                    TypeCodeableConcept
                    24. SubmittedMedication.ingredient
                    Definition

                    Ingredient information for this medication.

                    ShortMedication Ingredients
                    Control0..*
                    TypeBackboneElement
                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    26. SubmittedMedication.ingredient.id
                    Definition

                    Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                    ShortUnique id for inter-element referencing
                    Control0..1
                    This element is affected by the following invariants: ele-1
                    Typeid
                    Is Modifierfalse
                    XML FormatIn the XML format, this property is represented as an attribute.
                    Summaryfalse
                    28. SubmittedMedication.ingredient.extension
                    Definition

                    May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                    ShortAdditional content defined by implementations
                    Comments

                    There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                    Control0..*
                    TypeExtension
                    Is Modifierfalse
                    Summaryfalse
                    Alternate Namesextensions, user content
                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                    SlicingThis element introduces a set of slices on SubmittedMedication.ingredient.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                    • value @ url
                    • 30. SubmittedMedication.ingredient.modifierExtension
                      Definition

                      May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                      Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                      ShortExtensions that cannot be ignored even if unrecognized
                      Comments

                      There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                      Control0..*
                      TypeExtension
                      Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                      Summarytrue
                      Requirements

                      Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                      Alternate Namesextensions, user content, modifiers
                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                      ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                      32. SubmittedMedication.ingredient.type
                      Definition

                      A code that indicates the role the ingredient has in this medication, eg. active, flavouring, base, etc.

                      ShortIngredient Type
                      Control1..1
                      Typecode
                      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                      34. SubmittedMedication.ingredient.unii
                      Definition

                      The UNII that identifies the ingredient substance.

                      ShortIngredient Code
                      Control1..1
                      TypeCodeableConcept
                      36. SubmittedMedication.ingredient.name
                      Definition

                      The name of the ingredient.

                      ShortIngredient Name
                      Control1..1
                      Typestring
                      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                      38. SubmittedMedication.ingredient.strength
                      Definition

                      How much of the ingredient is present in the medication.

                      ShortIngredient Strength
                      Control0..1
                      TypeRatio
                      40. SubmittedMedication.ingredient.activeMoiety
                      Definition

                      The active moeity that corresponds to this ingredient.

                      ShortIngredient Active Moiety
                      Control1..2
                      TypeBackboneElement
                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                      42. SubmittedMedication.ingredient.activeMoiety.id
                      Definition

                      Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                      ShortUnique id for inter-element referencing
                      Control0..1
                      This element is affected by the following invariants: ele-1
                      Typeid
                      Is Modifierfalse
                      XML FormatIn the XML format, this property is represented as an attribute.
                      Summaryfalse
                      44. SubmittedMedication.ingredient.activeMoiety.extension
                      Definition

                      May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                      ShortAdditional content defined by implementations
                      Comments

                      There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                      Control0..*
                      TypeExtension
                      Is Modifierfalse
                      Summaryfalse
                      Alternate Namesextensions, user content
                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                      ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                      SlicingThis element introduces a set of slices on SubmittedMedication.ingredient.activeMoiety.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                      • value @ url
                      • 46. SubmittedMedication.ingredient.activeMoiety.modifierExtension
                        Definition

                        May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                        Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                        ShortExtensions that cannot be ignored even if unrecognized
                        Comments

                        There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                        Control0..*
                        TypeExtension
                        Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                        Summarytrue
                        Requirements

                        Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                        Alternate Namesextensions, user content, modifiers
                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                        48. SubmittedMedication.ingredient.activeMoiety.unii
                        Definition

                        The UNII that identifies the ingredient's active moiety.

                        ShortActive Moiety Code
                        Control1..1
                        TypeCodeableConcept
                        50. SubmittedMedication.ingredient.activeMoiety.name
                        Definition

                        The name of the ingredient's active moiety.

                        ShortActive Moiety Name
                        Control1..1
                        Typestring
                        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                        52. SubmittedMedication.ingredient.strengthReference
                        Definition

                        An ingredient that is used as the reference for the strength.

                        ShortReference Ingredient for Strength
                        Control0..1
                        TypeBackboneElement
                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        54. SubmittedMedication.ingredient.strengthReference.id
                        Definition

                        Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                        ShortUnique id for inter-element referencing
                        Control0..1
                        This element is affected by the following invariants: ele-1
                        Typeid
                        Is Modifierfalse
                        XML FormatIn the XML format, this property is represented as an attribute.
                        Summaryfalse
                        56. SubmittedMedication.ingredient.strengthReference.extension
                        Definition

                        May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                        ShortAdditional content defined by implementations
                        Comments

                        There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                        Control0..*
                        TypeExtension
                        Is Modifierfalse
                        Summaryfalse
                        Alternate Namesextensions, user content
                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                        SlicingThis element introduces a set of slices on SubmittedMedication.ingredient.strengthReference.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                        • value @ url
                        • 58. SubmittedMedication.ingredient.strengthReference.modifierExtension
                          Definition

                          May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                          Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                          ShortExtensions that cannot be ignored even if unrecognized
                          Comments

                          There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                          Control0..*
                          TypeExtension
                          Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                          Summarytrue
                          Requirements

                          Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                          Alternate Namesextensions, user content, modifiers
                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                          ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                          60. SubmittedMedication.ingredient.strengthReference.unii
                          Definition

                          The UNII that identifies the reference ingredient.

                          ShortReference Ingredient Code
                          Control1..1
                          TypeCodeableConcept
                          62. SubmittedMedication.ingredient.strengthReference.name
                          Definition

                          The name of the reference ingredient.

                          ShortReference Ingredient Name
                          Control1..1
                          Typestring
                          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                          64. SubmittedMedication.packaging
                          Definition

                          Information about the various packaging of the medication.

                          ShortMedication Packaging
                          Control0..1
                          TypeBackboneElement
                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                          66. SubmittedMedication.packaging.id
                          Definition

                          Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                          ShortUnique id for inter-element referencing
                          Control0..1
                          This element is affected by the following invariants: ele-1
                          Typeid
                          Is Modifierfalse
                          XML FormatIn the XML format, this property is represented as an attribute.
                          Summaryfalse
                          68. SubmittedMedication.packaging.extension
                          Definition

                          May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                          ShortAdditional content defined by implementations
                          Comments

                          There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                          Control0..*
                          TypeExtension
                          Is Modifierfalse
                          Summaryfalse
                          Alternate Namesextensions, user content
                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                          ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                          SlicingThis element introduces a set of slices on SubmittedMedication.packaging.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                          • value @ url
                          • 70. SubmittedMedication.packaging.modifierExtension
                            Definition

                            May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                            Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                            ShortExtensions that cannot be ignored even if unrecognized
                            Comments

                            There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                            Control0..*
                            TypeExtension
                            Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                            Summarytrue
                            Requirements

                            Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                            Alternate Namesextensions, user content, modifiers
                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                            ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                            72. SubmittedMedication.packaging.quantity
                            Definition

                            Amount of medication in the package.

                            ShortAmount of medication in the package.
                            Control1..1
                            TypeQuantity
                            74. SubmittedMedication.packaging.type
                            Definition

                            The type of the packaging.

                            ShortPackaging Type
                            Control1..1
                            TypeCodeableConcept
                            76. SubmittedMedication.packaging.code
                            Definition

                            The NDC package code that corresponds to this packaging.

                            ShortPackaging Identifier
                            Control0..1
                            TypeCodeableConcept
                            78. SubmittedMedication.packaging.sample
                            Definition

                            Indicates whether the package is a drug sample.

                            ShortDrug Sample Flag
                            Control1..1
                            Typeboolean
                            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                            80. SubmittedMedication.packaging.combinationMedicationType
                            Definition

                            Indicates the type of combination medication, if applicable.

                            ShortCombination Medication Type
                            Control0..1
                            TypeCodeableConcept
                            82. SubmittedMedication.packaging.marketingStatusPeriod
                            Definition

                            The start and end date of when this package is on the market.

                            ShortMarketing Status Period
                            Control0..1
                            TypePeriod
                            84. SubmittedMedication.packaging.characteristic
                            Definition

                            Properties that provide extra information about the packaging.

                            ShortPackaging Characteristics
                            Control0..*
                            TypeSeettp://hl7.org/fhir/us/spl/StructureDefinition/SubmittedMedicationLogicalModel#SubmittedMedication.characteristic
                            86. SubmittedMedication.packaging.packaging
                            Definition

                            Packaging that contains this package.

                            ShortOuter Packaging
                            Control0..1
                            TypeSeettp://hl7.org/fhir/us/spl/StructureDefinition/SubmittedMedicationLogicalModel#SubmittedMedication.packaging
                            88. SubmittedMedication.part
                            Definition

                            Information about parts of the medication.

                            ShortMedication Part
                            Control0..*
                            TypeBackboneElement
                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                            90. SubmittedMedication.part.id
                            Definition

                            Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                            ShortUnique id for inter-element referencing
                            Control0..1
                            This element is affected by the following invariants: ele-1
                            Typeid
                            Is Modifierfalse
                            XML FormatIn the XML format, this property is represented as an attribute.
                            Summaryfalse
                            92. SubmittedMedication.part.extension
                            Definition

                            May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                            ShortAdditional content defined by implementations
                            Comments

                            There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                            Control0..*
                            TypeExtension
                            Is Modifierfalse
                            Summaryfalse
                            Alternate Namesextensions, user content
                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                            ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                            SlicingThis element introduces a set of slices on SubmittedMedication.part.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                            • value @ url
                            • 94. SubmittedMedication.part.modifierExtension
                              Definition

                              May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                              Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                              ShortExtensions that cannot be ignored even if unrecognized
                              Comments

                              There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                              Control0..*
                              TypeExtension
                              Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                              Summarytrue
                              Requirements

                              Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                              Alternate Namesextensions, user content, modifiers
                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                              ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                              96. SubmittedMedication.part.quantity
                              Definition

                              Amount of parts in the medication.

                              ShortPart Quantity
                              Control1..1
                              TypeQuantity
                              98. SubmittedMedication.part.Medication
                              Definition

                              Medication information for this part.

                              ShortPart Medication
                              Control1..1
                              TypeReference(Submitted Medication Logical Model)
                              100. SubmittedMedication.part.marketing
                              Definition

                              Marketing Information about this part.

                              ShortPart Marketing
                              Control0..1
                              TypeSeettp://hl7.org/fhir/us/spl/StructureDefinition/SubmittedMedicationLogicalModel#SubmittedMedication.marketing
                              102. SubmittedMedication.marketing
                              Definition

                              Information about the marketing category and an associated application.

                              ShortMarketing Application Information
                              Control0..1
                              TypeBackboneElement
                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                              104. SubmittedMedication.marketing.id
                              Definition

                              Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                              ShortUnique id for inter-element referencing
                              Control0..1
                              This element is affected by the following invariants: ele-1
                              Typeid
                              Is Modifierfalse
                              XML FormatIn the XML format, this property is represented as an attribute.
                              Summaryfalse
                              106. SubmittedMedication.marketing.extension
                              Definition

                              May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                              ShortAdditional content defined by implementations
                              Comments

                              There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                              Control0..*
                              TypeExtension
                              Is Modifierfalse
                              Summaryfalse
                              Alternate Namesextensions, user content
                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                              ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                              SlicingThis element introduces a set of slices on SubmittedMedication.marketing.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                              • value @ url
                              • 108. SubmittedMedication.marketing.modifierExtension
                                Definition

                                May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                                Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                                ShortExtensions that cannot be ignored even if unrecognized
                                Comments

                                There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                Control0..*
                                TypeExtension
                                Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                                Summarytrue
                                Requirements

                                Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                                Alternate Namesextensions, user content, modifiers
                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                110. SubmittedMedication.marketing.number
                                Definition

                                The application number for this medication.

                                ShortMarkting Application Number
                                Control0..1
                                TypeIdentifier
                                112. SubmittedMedication.marketing.category
                                Definition

                                The marketing category for this medication.

                                ShortMarketing Category
                                Control0..1
                                TypeCodeableConcept
                                114. SubmittedMedication.marketing.approvalDate
                                Definition

                                The approval date of the marketing applicaiton.

                                ShortMarketing Approval Date
                                Control0..1
                                TypedateTime
                                Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                116. SubmittedMedication.marketingStatusPeriod
                                Definition

                                The start and end date of when the medication is on the market.

                                ShortMarketing Status Period
                                Control1..1
                                TypePeriod
                                118. SubmittedMedication.characteristic
                                Definition

                                Properties that provide extra information about the medication.

                                ShortMedication Characteristics
                                Control0..*
                                TypeBackboneElement
                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                120. SubmittedMedication.characteristic.id
                                Definition

                                Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                ShortUnique id for inter-element referencing
                                Control0..1
                                This element is affected by the following invariants: ele-1
                                Typeid
                                Is Modifierfalse
                                XML FormatIn the XML format, this property is represented as an attribute.
                                Summaryfalse
                                122. SubmittedMedication.characteristic.extension
                                Definition

                                May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                                ShortAdditional content defined by implementations
                                Comments

                                There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                Control0..*
                                TypeExtension
                                Is Modifierfalse
                                Summaryfalse
                                Alternate Namesextensions, user content
                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                SlicingThis element introduces a set of slices on SubmittedMedication.characteristic.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                                • value @ url
                                • 124. SubmittedMedication.characteristic.modifierExtension
                                  Definition

                                  May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                                  Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                                  ShortExtensions that cannot be ignored even if unrecognized
                                  Comments

                                  There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                  Control0..*
                                  TypeExtension
                                  Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                                  Summarytrue
                                  Requirements

                                  Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                                  Alternate Namesextensions, user content, modifiers
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                  126. SubmittedMedication.characteristic.type
                                  Definition

                                  A code that identifies the characteristic.

                                  ShortCharacteristic Type
                                  Control1..1
                                  TypeCodeableConcept
                                  128. SubmittedMedication.characteristic.value[x]
                                  Definition

                                  The value of the characteristic.

                                  ShortCharacteristic Value
                                  Control1..1
                                  TypeChoice of: Quantity, integer, Range, CodeableConcept, string, base64Binary, boolean
                                  [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                                  Primitive ValueThis primitive element may be present, or absent, or replaced by an extension