DescriptionCompositionBundle
type: Bundle
node role: treeRoot
id:
  v: DescriptionCompositionBundle
meta:
  profile:
    v: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-ectd-document-32p10
    link: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-ectd-document-32p10
identifier:
  system:
    v: urn:ietf:rfc:3986
type:
  v: document
timestamp:
  v: 2023-12-09T07:12:23.538Z

urn:…
type: Composition
meta:
  profile:
    v: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/ectd-composition-32p10
    link: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/ectd-composition-32p10
text:
  status:
    v: generated
  div: Generated Narrative: Composition 5dfbbf17-05c0-441d-af66-7a66072f4ae4 Profile: eCTD Product Description and Composition status: Final type: m3.2.p.1 description and composition of the drug product date: 2023-12-09 07:12:23+0000 author: Bundle: identifier = UUID:a242b79e-b706-49d3-93ba-b4364ab2baa3; type = document; timestamp = 2024-07-01 12:34:56+0000 title: eCTD Product Description and Composition for Example1Drug
status:
  v: final
type:
  coding:
    system:
      v: http://terminology.hl7.org/CodeSystem/ICHContextOfUse
    code:
      v: ich_3.2.p.1
    display:
      v: m3.2.p.1 description and composition of the drug product
date:
  v: 2023-12-09T07:12:23.537Z
title:
  v: eCTD Product Description and Composition for Example1Drug
section:
  title:
    v: Product Description for Example1Drug
  code:
    text:
      v: Product Description
section:
  title:
    v: Product Composition for Example1Drug
  code:
    text:
      v: Product Composition
section:
  title:
    v: Container Closure Description for Example1Drug
  code:
    text:
      v: Product Container Closure Description

urn:…
type: PackagedProductDefinition
meta:
  profile:
    v: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/ContainerClosure
    link: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/ContainerClosure
text:
  status:
    v: generated
  div: Generated Narrative: PackagedProductDefinition 77ad6922-9c59-43d1-93cb-29d063cc2e8c Profile: ContainerClosure packageFor: Bundle: identifier = UUID:8a5a9684-f8fb-4f21-a397-a1a0996b2b7f; type = document; timestamp = 2023-12-09 07:12:23+0000 description: Plastic Bottle made of high-density polyethylene (HDPE). The plastic is chosen for its resistance to moisture and its ability to maintain the integrity of the drug. Child-Resistant Cap: The cap features a Push-and-Turn Cap that he user to push down on the cap while turning it, which is difficult for children but manageable for adults. attachedDocument: Bundle: identifier = UUID:8a5a9684-f8fb-4f21-a397-a1a0996b2b7f; type = document; timestamp = 2023-12-09 07:12:23+0000 Packagings - Type * BOTTLE
description:
  v: Plastic Bottle made of high-density polyethylene (HDPE). The plastic is chosen for its resistance to moisture and its ability to maintain the integrity of the drug. Child-Resistant Cap: The cap features a Push-and-Turn Cap that he user to push down on the cap while turning it, which is difficult for children but manageable for adults.
packaging:
  type:
    coding:
      system:
        v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
      code:
        v: C43169
      display:
        v: BOTTLE
    coding:
      system:
        v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
      code:
        v: C96114
      display:
        v: Child-resistant, Plastic

urn:…
type: MedicinalProductDefinition
meta:
  profile:
    v: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-drug-product-description
    link: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-drug-product-description
text:
  status:
    v: generated
  div: Generated Narrative: MedicinalProductDefinition 5772a6f2-cde1-4903-bfcf-1639340205cc Profile: Drug Product Description description: A tablet consisting of two layers where one provides immediate release and of the two drugs (Figure in 3.2.P.1.3). Both immediate-release layers are composed of granules with a matrix layer for the modified release of the drug. combinedPharmaceuticalDoseForm: TABLET, MULTILAYER route: ORAL name productName: ASPIRIN 200mg, ACETAMINOPHEN 300mg type: Non-Proprietary part part: ASPIRIN type: scientific name part part: 200mg type: ASPIRIN part part: ACETAMINOPHEN type: scientific name part part: 300mg type: ACETAMINOPHEN
description:
  v: A tablet consisting of two layers where one provides immediate release and of the two drugs (Figure in 3.2.P.1.3). Both immediate-release layers are composed of granules with a matrix layer for the modified release of the drug.
combined pharmaceutical dose form:
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C42964
    display:
      v: TABLET, MULTILAYER
route:
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C38288
    display:
      v: ORAL
name:
  product name:
    v: ASPIRIN 200mg, ACETAMINOPHEN 300mg
  type:
    coding:
      system:
        v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
      code:
        v: C96971
      display:
        v: Nonproprietary Name
    text:
      v: Non-Proprietary
  part:
    part:
      v: ASPIRIN
  part:
    part:
      v: 200mg
    type:
      text:
        v: ASPIRIN
  part:
    part:
      v: ACETAMINOPHEN
  part:
    part:
      v: 300mg
    type:
      text:
        v: ACETAMINOPHEN

urn:…
type: ManufacturedItemDefinition
meta:
  profile:
    v: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-product-part
    link: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-product-part
text:
  status:
    v: extensions
  div: Generated Narrative: ManufacturedItemDefinition a8316fc9-8ca8-4115-81c1-9f8f84c99149 Profile: Manufactured Drug Product identifier: Example1Drug status: Draft manufacturedDoseForm: Tablet property type: Product Overall Release Profile value: Extended-Release Profile property type: Product Schematic value: image/png: [binary] property type: Product Weight Type value: Mass property type: Product Total Weight Numeric Numerator value: 1201 milligram (Details: UCUM codemg = 'mg') property type: Quality Standard value: USP-NF property type: Sterile Product Indicator value: true property type: Product Overall Release Mechanism value: Matrix property type: Coating Indicator value: false property type: Tablet Layer Count value: 2 1 (Details: UCUM code1 = '1') property type: Tablet Bead Type Count value: 0 1 (Details: UCUM code1 = '1') property type: Product Total Weight Numeric Denominator value: 1 1* (Details: UCUM code1 = '1') component type: Layer amount: 463 milligram (Details: UCUM codemg = 'mg'), 38.55 percent (Details: UCUM code% = '%') constituent amount: 200 milligram (Details: UCUM codemg = 'mg'), 43.19 percent (Details: UCUM code% = '%') location: Purple Layer function: Active Ingredient HasIngredients - Reference * Bundle: identifier = UUID:8a5a9684-f8fb-4f21-a397-a1a0996b2b7f; type = document; timestamp = 2023-12-09 07:12:23+0000 constituent amount: 262 milligram (Details: UCUM codemg = 'mg'), 56.59 percent (Details: UCUM code% = '%') location: Purple Layer function: Inactive Ingredient, Filler HasIngredients - Reference * Bundle: identifier = UUID:8a5a9684-f8fb-4f21-a397-a1a0996b2b7f; type = document; timestamp = 2023-12-09 07:12:23+0000 constituent amount: 1 milligram (Details: UCUM codemg = 'mg'), 0.22 percent (Details: UCUM code% = '%') location: Purple Layer function: Inactive Ingredient, Coloring Agent HasIngredients - Reference * Bundle: identifier = UUID:8a5a9684-f8fb-4f21-a397-a1a0996b2b7f; type = document; timestamp = 2023-12-09 07:12:23+0000 Propertie…
identifier:
  value:
    v: Example1Drug
status:
  v: draft
manufactured dose form:
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C154605
    display:
      v: Tablet
property:
  type:
    text:
      v: Product Overall Release Profile
  value: CodeableConcept
    coding:
      system:
        v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
      code:
        v: C42713
      display:
        v: Extended-Release Profile
property:
  type:
    text:
      v: Product Schematic
  value: Attachment
    content type:
      v: image/png
    title:
      v: example1DrugSchematic.png
property:
  type:
    text:
      v: Product Weight Type
  value: CodeableConcept
    coding:
      system:
        v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
      code:
        v: C168628
      display:
        v: Mass
property:
  type:
    text:
      v: Product Total Weight Numeric Numerator
  value: Quantity
    value:
      v: 1201
    unit:
      v: milligram
    system:
      v: http://unitsofmeasure.org
    code:
      v: mg
property:
  type:
    text:
      v: Quality Standard
  value: CodeableConcept
    coding:
      system:
        v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
      code:
        v: C134006
      display:
        v: USP-NF
property:
  type:
    text:
      v: Sterile Product Indicator
  value: boolean
    v: true
property:
  type:
    text:
      v: Product Overall Release Mechanism
  value: CodeableConcept
    coding:
      system:
        v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
      code:
        v: C203359
      display:
        v: Matrix
property:
  type:
    text:
      v: Coating Indicator
  value: boolean
    v: false
property:
  type:
    text:
      v: Tablet Layer Count
  value: Quantity
    value:
      v: 2
    system:
      v: http://unitsofmeasure.org
    code:
      v: 1
property:
  type:
    text:
      v: Tablet Bead Type Count
  value: Quantity
    value:
      v: 0
    system:
      v: http://unitsofmeasure.org
    code:
      v: 1
property:
  type:
    text:
      v: Product Total Weight Numeric Denominator
  value: Quantity
    value:
      v: 1
    unit:
      v: 1*
    system:
      v: http://unitsofmeasure.org
    code:
      v: 1
component:
  type:
    coding:
      system:
        v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
      code:
        v: C66831
      display:
        v: Layer
  amount:
    value:
      v: 463
    unit:
      v: milligram
    system:
      v: http://unitsofmeasure.org
    code:
      v: mg
  amount:
    value:
      v: 38.55
    unit:
      v: percent
    system:
      v: http://unitsofmeasure.org
    code:
      v: %
  constituent:
    amount:
      value:
        v: 200
      unit:
        v: milligram
      system:
        v: http://unitsofmeasure.org
      code:
        v: mg
    amount:
      value:
        v: 43.19
      unit:
        v: percent
      system:
        v: http://unitsofmeasure.org
      code:
        v: %
    location:
      text:
        v: Purple Layer
  constituent:
    amount:
      value:
        v: 262
      unit:
        v: milligram
      system:
        v: http://unitsofmeasure.org
      code:
        v: mg
    amount:
      value:
        v: 56.59
      unit:
        v: percent

urn:…
type: Ingredient
meta:
  profile:
    v: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-component
    link: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-component
text:
  status:
    v: extensions
  div: Generated Narrative: Ingredient fc09842a-8f71-48f2-9f9f-ff2441b2eb6f Profile: Drug Product Component status: Draft role: Active Ingredient substance Codes - Reference * Bundle: identifier = UUID:8a5a9684-f8fb-4f21-a397-a1a0996b2b7f; type = document; timestamp = 2023-12-09 07:12:23+0000 strength Strength Type: Mass concentration: 200 milligram (Details: UCUM codemg = 'mg')/1 arbitrary unit (Details: UCUM code[arb'U] = '[arb'U]') textConcentration: 200mg strength concentration: 16.65 percent (Details: UCUM code% = '%')
status:
  v: draft
role:
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C82533
    display:
      v: Active Ingredient
substance:
  strength:
    extension:
      url:
        v: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/strength-extension
      value: CodeableConcept
    concentration: Ratio
    text concentration:
      v: 200mg
  strength:
    concentration: Quantity
      value:
        v: 16.65
      unit:
        v: percent
      system:
        v: http://unitsofmeasure.org
      code:
        v: %

urn:…
type: Ingredient
meta:
  profile:
    v: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-component
    link: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-component
text:
  status:
    v: extensions
  div: Generated Narrative: Ingredient 7f10a35e-228d-42db-8918-6ccada78454d Profile: Drug Product Component status: Draft role: Active Ingredient substance Codes - Reference * Bundle: identifier = UUID:8a5a9684-f8fb-4f21-a397-a1a0996b2b7f; type = document; timestamp = 2023-12-09 07:12:23+0000 strength Strength Type: Mass concentration: 300 milligram (Details: UCUM codemg = 'mg')/1 arbitrary unit (Details: UCUM code[arb'U] = '[arb'U]') textConcentration: 300mg strength concentration: 24.98 percent (Details: UCUM code% = '%')
status:
  v: draft
role:
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C82533
    display:
      v: Active Ingredient
substance:
  strength:
    extension:
      url:
        v: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/strength-extension
      value: CodeableConcept
    concentration: Ratio
    text concentration:
      v: 300mg
  strength:
    concentration: Quantity
      value:
        v: 24.98
      unit:
        v: percent
      system:
        v: http://unitsofmeasure.org
      code:
        v: %

urn:…
type: Ingredient
meta:
  profile:
    v: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-component
    link: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-component
text:
  status:
    v: extensions
  div: Generated Narrative: Ingredient d01421cc-6488-468b-a676-d3e7281875e2 Profile: Drug Product Component status: Draft role: Inactive Ingredient substance Codes - Reference * Bundle: identifier = UUID:8a5a9684-f8fb-4f21-a397-a1a0996b2b7f; type = document; timestamp = 2023-12-09 07:12:23+0000 strength Strength Type: Mass concentration: 700 milligram (Details: UCUM codemg = 'mg')/1 arbitrary unit (Details: UCUM code[arb'U] = '[arb'U]') textConcentration: 700mg strength concentration: 58.28 percent (Details: UCUM code% = '%')
status:
  v: draft
role:
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C42637
    display:
      v: Inactive Ingredient
substance:
  strength:
    extension:
      url:
        v: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/strength-extension
      value: CodeableConcept
    concentration: Ratio
    text concentration:
      v: 700mg
  strength:
    concentration: Quantity
      value:
        v: 58.28
      unit:
        v: percent
      system:
        v: http://unitsofmeasure.org
      code:
        v: %

urn:…
type: Ingredient
meta:
  profile:
    v: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-component
    link: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-component
text:
  status:
    v: extensions
  div: Generated Narrative: Ingredient 3791c4ce-2b43-4d7b-b195-0e5f88f28dab Profile: Drug Product Component status: Draft role: Inactive Ingredient substance Codes - Reference * Bundle: identifier = UUID:8a5a9684-f8fb-4f21-a397-a1a0996b2b7f; type = document; timestamp = 2023-12-09 07:12:23+0000 strength Strength Type: Mass concentration: 1 milligram (Details: UCUM codemg = 'mg')/1 arbitrary unit (Details: UCUM code[arb'U] = '[arb'U]') textConcentration: 1mg strength concentration: 0.08 percent (Details: UCUM code% = '%')
status:
  v: draft
role:
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C42637
    display:
      v: Inactive Ingredient
substance:
  strength:
    extension:
      url:
        v: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/strength-extension
      value: CodeableConcept
    concentration: Ratio
    text concentration:
      v: 1mg
  strength:
    concentration: Quantity
      value:
        v: 0.08
      unit:
        v: percent
      system:
        v: http://unitsofmeasure.org
      code:
        v: %

urn:…
type: SubstanceDefinition
meta:
  profile:
    v: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-component-substance
    link: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-component-substance
text:
  status:
    v: generated
  div: Generated Narrative: SubstanceDefinition 2d70d504-8cc6-4282-81d4-b20b0a98b78b Profile: Component Substance identifier: aspirin classification: Chemical grade: USP-NF manufacturer: Bundle: identifier = UUID:49d3b79e-b436-a242-93ba-b706b4364ab2; type = document; timestamp = 2024-08-29 12:34:56+0000 supplier: Bundle: identifier = UUID:32532fe8-1bfb-4a0a-998d-9294742a9519; type = document; timestamp = 2024-06-19 21:06:21+0000 Codes - Code * R16CO5Y76E Names - Name Type Preferred * ASPIRIN GSRS Preferred Term true SourceMaterials - Type * Chemical
identifier:
  value:
    v: aspirin
classification:
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C48807
    display:
      v: Chemical
grade:
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C134006
    display:
      v: USP-NF
code:
  code:
    coding:
      system:
        v: http://fdasis.nlm.nih.gov
      code:
        v: R16CO5Y76E
name:
  name:
    v: ASPIRIN
  type:
    coding:
      system:
        v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
      code:
        v: C203355
      display:
        v: GSRS Preferred Term
  preferred:
    v: true
source material:
  type:
    coding:
      system:
        v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
      code:
        v: C48807
      display:
        v: Chemical

urn:…
type: SubstanceDefinition
meta:
  profile:
    v: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-component-substance
    link: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-component-substance
text:
  status:
    v: generated
  div: Generated Narrative: SubstanceDefinition fc878c4f-a98c-427c-816b-e03ccdf0e712 Profile: Component Substance identifier: acetaminophen classification: Chemical grade: USP-NF manufacturer: Bundle: identifier = UUID:49d3b79e-b436-a242-93ba-b706b4364ab2; type = document; timestamp = 2024-08-29 12:34:56+0000 supplier: Bundle: identifier = UUID:32532fe8-1bfb-4a0a-998d-9294742a9519; type = document; timestamp = 2024-06-19 21:06:21+0000 Codes - Code * 362O9ITL9D Names - Name Type Preferred * ACETAMINOPHEN GSRS Preferred Term true SourceMaterials - Type * Chemical
identifier:
  value:
    v: acetaminophen
classification:
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C48807
    display:
      v: Chemical
grade:
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C134006
    display:
      v: USP-NF
code:
  code:
    coding:
      system:
        v: http://fdasis.nlm.nih.gov
      code:
        v: 362O9ITL9D
name:
  name:
    v: ACETAMINOPHEN
  type:
    coding:
      system:
        v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
      code:
        v: C203355
      display:
        v: GSRS Preferred Term
  preferred:
    v: true
source material:
  type:
    coding:
      system:
        v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
      code:
        v: C48807
      display:
        v: Chemical

urn:…
type: SubstanceDefinition
meta:
  profile:
    v: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-component-substance
    link: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-component-substance
text:
  status:
    v: generated
  div: Generated Narrative: SubstanceDefinition 393a14e7-3edc-4373-bbe5-9e569d504a1c Profile: Component Substance identifier: Maize starch classification: Mixture grade: Company Standard manufacturer: Bundle: identifier = UUID:7ce2088d-d281-4e2f-9a25-120a1f9805d1; type = document; timestamp = 2023-12-05 01:34:39+0000 supplier: Bundle: identifier = UUID:32532fe8-1bfb-4a0a-998d-9294742a9519; type = document; timestamp = 2024-06-19 21:06:21+0000 Codes - Code * O8232NY3SJ Names - Name Type Preferred * STARCH, CORN GSRS Preferred Term true SourceMaterials - Type Genus Species Part CountryOfOrigin * Plant zea mays kernel Argentina
identifier:
  value:
    v: Maize starch
classification:
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C45305
    display:
      v: Mixture
grade:
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C134009
    display:
      v: Company Standard
code:
  code:
    coding:
      system:
        v: http://fdasis.nlm.nih.gov
      code:
        v: O8232NY3SJ
name:
  name:
    v: STARCH, CORN
  type:
    coding:
      system:
        v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
      code:
        v: C203355
      display:
        v: GSRS Preferred Term
  preferred:
    v: true
source material:
  type:
    coding:
      system:
        v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
      code:
        v: C14258
      display:
        v: Plant
  genus:
    text:
      v: zea
  species:
    text:
      v: mays
  part:
    text:
      v: kernel
  country of origin:
    coding:
      system:
        v: urn:iso:std:iso:3166
      code:
        v: ARG
      display:
        v: Argentina

urn:…
type: SubstanceDefinition
meta:
  profile:
    v: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-component-substance
    link: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-component-substance
text:
  status:
    v: generated
  div: Generated Narrative: SubstanceDefinition 496f83ad-2365-4b12-8672-a349d99f7d67 Profile: Component Substance identifier: Grape skin extract classification: Mixture grade: BP manufacturer: Bundle: identifier = UUID:7ce2088d-d281-4e2f-9a25-120a1f9805d1; type = document; timestamp = 2023-12-05 01:34:39+0000 supplier: Bundle: identifier = UUID:32532fe8-1bfb-4a0a-998d-9294742a9519; type = document; timestamp = 2024-06-19 21:06:21+0000 Codes - Code * 3GOV20705G Names - Name Type Preferred * WINE GRAPE GSRS Preferred Term true SourceMaterials - Type Genus Species Part CountryOfOrigin * Plant Vitis vinifera skin United States of America
identifier:
  value:
    v: Grape skin extract
classification:
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C45305
    display:
      v: Mixture
grade:
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C176793
    display:
      v: BP
code:
  code:
    coding:
      system:
        v: http://fdasis.nlm.nih.gov
      code:
        v: 3GOV20705G
name:
  name:
    v: WINE GRAPE
  type:
    coding:
      system:
        v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
      code:
        v: C203355
      display:
        v: GSRS Preferred Term
  preferred:
    v: true
source material:
  type:
    coding:
      system:
        v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
      code:
        v: C14258
      display:
        v: Plant
  genus:
    text:
      v: Vitis
  species:
    text:
      v: vinifera
  part:
    text:
      v: skin
  country of origin:
    coding:
      system:
        v: urn:iso:std:iso:3166
      code:
        v: USA
      display:
        v: United States of America

urn:…
type: Organization
meta:
  profile:
    v: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-organization
    link: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-organization
text:
  status:
    v: generated
  div: Generated Narrative: Organization 4f3e9af1-306b-4fad-bf04-7881400b266a Profile: Basic Organization identifier: DUNS/143265222 name: Wunderwerke Contacts - Address * Wunderwerke, 123 Scenic Road, CT, Bridgeport, USA 65478
identifier:
  type:
    coding:
      system:
        v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
      code:
        v: C134003
      display:
        v: DUNS
  system:
    v: urn:oid:1.3.6.1.4.1.519.1
  value:
    v: 143265222
name:
  v: Wunderwerke
contact:
  address:
    type:
      v: postal
    text:
      v: Wunderwerke, 123 Scenic Road, CT, Bridgeport, USA 65478
    line:
      v: 123 Scenic Road
    city:
      v: Bridgeport
    state:
      v: CT
    postal code:
      v: 65478
    country:
      v: USA

urn:…
type: Organization
meta:
  profile:
    v: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-organization
    link: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-organization
text:
  status:
    v: generated
  div: Generated Narrative: Organization 8ee60ed1-e22f-4d3b-ab08-8986e4e8e1d9 Profile: Basic Organization identifier: DUNS/123456789, DUNS/1234567 name: Sams BioPharm Contacts - Address * 2752 Main Street Princeton NJ 12345 USA
identifier:
  type:
    coding:
      system:
        v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
      code:
        v: C134003
      display:
        v: DUNS
  system:
    v: urn:oid:1.3.6.1.4.1.519.1
  value:
    v: 123456789
identifier:
  type:
    coding:
      system:
        v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
      code:
        v: C134003
      display:
        v: DUNS
  system:
    v: urn:oid:2.16.840.1.113883.4.82
  value:
    v: 1234567
name:
  v: Sams BioPharm
contact:
  address:
    type:
      v: postal
    line:
      v: 2752 Main Street
    city:
      v: Princeton
    state:
      v: NJ
    postal code:
      v: 12345
    country:
      v: USA

urn:…
type: Organization
meta:
  profile:
    v: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-organization
    link: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-organization
text:
  status:
    v: generated
  div: Generated Narrative: Organization 4b565cf3-5353-48af-8cd6-5ccf4e9fd579 Profile: Basic Organization identifier: DUNS/783452221, FEI/6913973 name: Manufacturing Site (J. Jones Research) Contacts - Address * Manufacturing Site (J. Jones Research), 444 Grant Street, Bedford, NY, United States
identifier:
  type:
    coding:
      system:
        v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
      code:
        v: C134003
      display:
        v: DUNS
  system:
    v: urn:oid:1.3.6.1.4.1.519.1
  value:
    v: 783452221
identifier:
  type:
    coding:
      system:
        v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
      code:
        v: C134004
      display:
        v: FEI
  system:
    v: urn:oid:2.16.840.1.113883.4.82
  value:
    v: 6913973
name:
  v: Manufacturing Site (J. Jones Research)
contact:
  address:
    type:
      v: postal
    text:
      v: Manufacturing Site (J. Jones Research), 444 Grant Street, Bedford, NY, United States
    line:
      v: 444 Grant Street
    city:
      v: Bedford
    state:
      v: NY
    postal code:
      v: 15600
    country:
      v: USA

urn:…
type: Organization
meta:
  profile:
    v: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-organization
    link: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-organization
text:
  status:
    v: generated
  div: Generated Narrative: Organization d9e7c2f7-0f59-4645-bb6d-5a8dd2425049 Profile: Basic Organization identifier: DUNS/173265332 name: Mega Chem Supply Contacts - Address * Mega Chem Supply, 350 W Main Street, Rochester, NY, United States
identifier:
  type:
    coding:
      system:
        v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
      code:
        v: C134003
      display:
        v: DUNS
  system:
    v: urn:oid:1.3.6.1.4.1.519.1
  value:
    v: 173265332
name:
  v: Mega Chem Supply
contact:
  address:
    type:
      v: postal
    text:
      v: Mega Chem Supply, 350 W Main Street, Rochester, NY, United States
    line:
      v: 350 W Main Street
    city:
      v: Rochester
    state:
      v: NY
    postal code:
      v: 14608
    country:
      v: USA

urn:…
type: DocumentReference
meta:
  profile:
    v: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-graphic-reference
    link: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-graphic-reference
text:
  status:
    v: generated
  div: Generated Narrative: DocumentReference 928a3bb5-7be3-4d6e-830f-1a2fc6dcee9b Profile: Graphic Reference status: Current content Attachments - ContentType Data Title * image/png (base64 data - 499,360 base64 chars) bottlePlusCap.png
status:
  v: current
content:
  attachment:
    content type:
      v: image/png
    title:
      v: bottlePlusCap.png

v: SCI

v: STR

v: SCI

v: STR

v: C203881

v: Active core/granulate

v: C82533

v: Active Ingredient

v: %

coding:
  system:
    v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
  code:
    v: C203883
  display:
    v: Intragranular
text:
  v: Purple Layer

coding:
  system:
    v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
  code:
    v: C42637
  display:
    v: Inactive Ingredient

coding:
  system:
    v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
  code:
    v: C42650
  display:
    v: Filler

amount:
  value:
    v: 1
  unit:
    v: milligram
  system:
    v: http://unitsofmeasure.org
  code:
    v: mg
amount:
  value:
    v: 0.22
  unit:
    v: percent
  system:
    v: http://unitsofmeasure.org
  code:
    v: %
location:
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C203883
    display:
      v: Intragranular
  text:
    v: Purple Layer
function:
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C42637
    display:
      v: Inactive Ingredient
function:
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C42656
    display:
      v: Coloring Agent

type:
  text:
    v: Product Part Identifier
value: CodeableConcept
  text:
    v: Example1Drug_LayerA

type:
  text:
    v: Product Part Release Profile
value: CodeableConcept
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C42730
    display:
      v: Delayed-Release Profile

type:
  text:
    v: Product Part Color Description
value: CodeableConcept
  text:
    v: Purple

modifier extension:
  url:
    v: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-amount-ratio
  value: Ratio
    numerator:
      value:
        v: 738
      unit:
        v: milligram
      system:
        v: http://unitsofmeasure.org
      code:
        v: mg
    denominator:
      value:
        v: 1
      unit:
        v: arbitrary unit
      system:
        v: http://unitsofmeasure.org
      code:
        v: [arb'U]
type:
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C66831
    display:
      v: Layer
amount:
  value:
    v: 61.45
  unit:
    v: percent
  system:
    v: http://unitsofmeasure.org
  code:
    v: %
constituent:
  amount:
    value:
      v: 300
    unit:
      v: milligram
    system:
      v: http://unitsofmeasure.org
    code:
      v: mg
  amount:
    value:
      v: 40.65
    unit:
      v: percent
    system:
      v: http://unitsofmeasure.org
    code:
      v: %
  location:
    coding:
      system:
        v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
      code:
        v: C203881
      display:
        v: Active core/granulate
    text:
      v: White Layer
  function:
    coding:
      system:
        v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
      code:
        v: C82533
      display:
        v: Active Ingredient
constituent:
  amount:
    value:
      v: 438
    unit:
      v: milligram
    system:
      v: http://unitsofmeasure.org
    code:
      v: mg
  amount:
    value:
      v: 59.35
    unit:
      v: percent
    system:
      v: http://unitsofmeasure.org
    code:
      v: %
  location:
    coding:
      system:
        v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
      code:
        v: C203883
      display:
        v: Intragranular
    text:
      v: White Layer
  function:
    coding:
      system:
        v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
      code:
        v: C42637
      display:
        v: Inactive Ingredient
  function:
    coding:
      system:
        v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
      code:
        v: C42650
      display:
        v: Filler
property:
  type:
    text:
      v: Product Part Identifier
  value: CodeableConcept
    text:
      v: Example1Drug_LayerB
property:
  type:
    text:
      v: Product Part Release Profile
  value: CodeableConcept
    coding:
      system:
        v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
      code:
        v: C42730
      display:
        v: Delayed-Release Profile
property:
  type:
    text:
      v: Product Part Color Description
  value: CodeableConcept
    text:
      v: White

system:
  v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
code:
  v: C168628
display:
  v: Mass

v: 200

v: milligram

v: mg

v: 1

v: arbitrary unit

v: [arb'U]

system:
  v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
code:
  v: C168628
display:
  v: Mass

v: 300

v: milligram

v: mg

v: 1

v: arbitrary unit

v: [arb'U]

system:
  v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
code:
  v: C168628
display:
  v: Mass

v: 700

v: milligram

v: mg

v: 1

v: arbitrary unit

v: [arb'U]

system:
  v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
code:
  v: C168628
display:
  v: Mass

v: 1

v: milligram

v: mg

v: 1

v: arbitrary unit

v: [arb'U]