EnbrelSyringeLabelBundle - SPL Mapping FHIR Implementation Guide v0.1.0

SPL Mapping FHIR Implementation Guide, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 0.1.0 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

Example Bundle: EnbrelSyringeLabelBundle

Document Details

Generated Narrative: Bundle These highlights do not include all the information needed to use ENBREL safely and effectively. See full prescribing information for ENBREL. ENBREL® (etanercept) injection, for subcutaneous use ENBREL® (etanercept) for injection, for subcutaneous use Initial U.S. Approval: 1998

Document Subject

Document Content

Generated Narrative: Composition EnbrelSyringeLabelComposition

identifier: Uniform Resource Identifier (URI)/urn:uuid:a002b40c-097d-47a5-957f-7a7b1807af7f

status: Final

type: HUMAN PRESCRIPTION DRUG LABEL

date: 2021-12-13

author: Organization Immunex Corporation

title: These highlights do not include all the information needed to use ENBREL safely and effectively. See full prescribing information for ENBREL. ENBREL® (etanercept) injection, for subcutaneous use ENBREL® (etanercept) for injection, for subcutaneous use Initial U.S. Approval: 1998

WARNING: SERIOUS INFECTIONS and MALIGNANCIES

SPL UNCLASSIFIED SECTION

1 INDICATIONS AND USAGE

1.1 Rheumatoid Arthritis

1.2 Polyarticular Juvenile Idiopathic Arthritis

1.3 Psoriatic Arthritis

1.4 Ankylosing Spondylitis

1.5 Plaque Psoriasis

2 DOSAGE AND ADMINISTRATION

2.1 Adult Patients

SPL UNCLASSIFIED SECTION

2.2 Pediatric Patients

2.3 Preparation of Enbrel

SPL UNCLASSIFIED SECTION

2.4 Monitoring to Assess Safety

SPL LISTING DATA ELEMENTS SECTION

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL - 50 mg/mL Cartridge Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL - 25 mg Vial Carton

Additional Resources Included in Document

Entry 1 - fullUrl = http://example.org/Composition/EnbrelSyringeLabelComposition

Resource Composition:

Generated Narrative: Composition EnbrelSyringeLabelComposition

identifier: Uniform Resource Identifier (URI)/urn:uuid:a002b40c-097d-47a5-957f-7a7b1807af7f
status: Final
type: HUMAN PRESCRIPTION DRUG LABEL
date: 2021-12-13
author: Organization Immunex Corporation
title: These highlights do not include all the information needed to use ENBREL safely and effectively. See full prescribing information for ENBREL. ENBREL® (etanercept) injection, for subcutaneous use ENBREL® (etanercept) for injection, for subcutaneous use Initial U.S. Approval: 1998

Entry 2 - fullUrl = http://example.org/Organization/ImmunexCorporation

Resource Organization:

Generated Narrative: Organization ImmunexCorporation

identifier: urn:oid:1.3.6.1.4.1.519.1/028134799
type: An organization that submits product labels.
name: Immunex Corporation

Entry 3 - fullUrl = http://example.org/MedicinalProductDefinition/Enbrel435Definition

Resource MedicinalProductDefinition:

Generated Narrative: MedicinalProductDefinition Enbrel435Definition

identifier: National drug codes/58406-435
route: SUBCUTANEOUS
MarketingStatuses
- Status DateRange
* active 2005-10-06 --> (ongoing)
name
productName: ENBREL
type: Proprietary Name
name
productName: etanercept
type: Generic Name (Non-Proprietary)

Entry 4 - fullUrl = http://example.org/ManufacturedItemDefinition/Enbrel50mgSolution

Resource ManufacturedItemDefinition:

Generated Narrative: ManufacturedItemDefinition Enbrel50mgSolution

status: Active
manufacturedDoseForm: SOLUTION

Entry 5 - fullUrl = http://example.org/Ingredient/Enbrel50mgSolutionActiveIngredient

Resource Ingredient:

Generated Narrative: Ingredient Enbrel50mgSolutionActiveIngredient

status: Active
for: ManufacturedItemDefinition: status = active; manufacturedDoseForm = SOLUTION
role: active ingredient - basis of strength
substance
Codes
- Reference
* SubstanceDefinition: identifier = http://fdasis.nlm.nih.gov#Unique Ingredient Identifier (UNII)#OP401G7OJC
Strengths
- Presentation[x]
* 50 mg (Details: UCUM codemg = 'mg')/1 mL (Details: UCUM codemL = 'mL')

Entry 6 - fullUrl = http://example.org/SubstanceDefinition/EnbrelIngredientDefinition

Resource SubstanceDefinition:

Generated Narrative: SubstanceDefinition EnbrelIngredientDefinition

identifier: Unique Ingredient Identifier (UNII)/OP401G7OJC
Moieties
- Identifier Name
* Unique Ingredient Identifier (UNII)/OP401G7OJC ETANERCEPT
Names
- Name
* ETANERCEPT

Entry 7 - fullUrl = http://example.org/Ingredient/Enbrel50mgSolutionIngredient1

Resource Ingredient:

Generated Narrative: Ingredient Enbrel50mgSolutionIngredient1

status: Active
for: ManufacturedItemDefinition: status = active; manufacturedDoseForm = SOLUTION
role: inactive ingredient
substance
Codes
- Concept
* ARGININE HYDROCHLORIDE
Strengths
- Presentation[x]
* 0.025 mmol (Details: UCUM codemmol = 'mmol')/1 mL (Details: UCUM codemL = 'mL')

Entry 8 - fullUrl = http://example.org/Ingredient/Enbrel50mgSolutionIngredient2

Resource Ingredient:

Generated Narrative: Ingredient Enbrel50mgSolutionIngredient2

status: Active
for: ManufacturedItemDefinition: status = active; manufacturedDoseForm = SOLUTION
role: inactive ingredient
substance
Codes
- Concept
* SODIUM CHLORIDE
Strengths
- Presentation[x]
* 0.12 mmol (Details: UCUM codemmol = 'mmol')/1 mL (Details: UCUM codemL = 'mL')

Entry 9 - fullUrl = http://example.org/Ingredient/Enbrel50mgSolutionIngredient3

Resource Ingredient:

Generated Narrative: Ingredient Enbrel50mgSolutionIngredient3

status: Active
for: ManufacturedItemDefinition: status = active; manufacturedDoseForm = SOLUTION
role: inactive ingredient
substance
Codes
- Concept
* SUCROSE
Strengths
- Presentation[x]
* 10 mg (Details: UCUM codemg = 'mg')/1 mL (Details: UCUM codemL = 'mL')

Entry 10 - fullUrl = http://example.org/PackagedProductDefinition/Enbrel435Package

Resource PackagedProductDefinition:

Generated Narrative: PackagedProductDefinition Enbrel435Package

packageFor: MedicinalProductDefinition: identifier = http://hl7.org/fhir/sid/ndc#National drug codes#58406-435; route = SUBCUTANEOUS
MarketingStatuses
- Status DateRange
* active 2005-10-05 --> (ongoing)
package
identifier: National drug codes/58406-435-04
type: CARTON
package

Entry 11 - fullUrl = http://example.org/RegulatedAuthorization/Enbrel435Marketing

Resource RegulatedAuthorization:

Generated Narrative: RegulatedAuthorization Enbrel435Marketing

identifier: urn:oid:2.16.840.1.113883.3.150/NDA103795
subject: MedicinalProductDefinition: identifier = http://hl7.org/fhir/sid/ndc#National drug codes#58406-435; route = SUBCUTANEOUS
type: NDA
region: United States of America

Entry 12 - fullUrl = http://example.org/MedicinalProductDefinition/Enbrel445Definition

Resource MedicinalProductDefinition:

Generated Narrative: MedicinalProductDefinition Enbrel445Definition

identifier: National drug codes/58406-445
route: SUBCUTANEOUS
MarketingStatuses
- Status DateRange
* active 2005-11-10 --> (ongoing)
name
productName: ENBREL
type: Proprietary Name
name
productName: etanercept
type: Generic Name (Non-Proprietary)

Entry 13 - fullUrl = http://example.org/PackagedProductDefinition/Enbrel445Package

Resource PackagedProductDefinition:

Generated Narrative: PackagedProductDefinition Enbrel445Package

packageFor: MedicinalProductDefinition: identifier = http://hl7.org/fhir/sid/ndc#National drug codes#58406-445; route = SUBCUTANEOUS
MarketingStatuses
- Status DateRange
* active 2005-11-10 --> (ongoing)
package
identifier: National drug codes/58406-445-04
type: CARTON
package

Entry 14 - fullUrl = http://example.org/RegulatedAuthorization/Enbrel445Marketing

Resource RegulatedAuthorization:

Generated Narrative: RegulatedAuthorization Enbrel445Marketing

identifier: urn:oid:2.16.840.1.113883.3.150/NDA103795
subject: MedicinalProductDefinition: identifier = http://hl7.org/fhir/sid/ndc#National drug codes#58406-445; route = SUBCUTANEOUS
type: NDA
region: United States of America

Entry 15 - fullUrl = http://example.org/MedicinalProductDefinition/Enbrel425Definition

Resource MedicinalProductDefinition:

Generated Narrative: MedicinalProductDefinition Enbrel425Definition

identifier: National drug codes/58406-425
MarketingStatuses
- Status DateRange
* active 2003-01-02 --> (ongoing)
name
productName: ENBREL
type: Proprietary Name
name
productName: etanercept
type: Generic Name (Non-Proprietary)

Entry 16 - fullUrl = http://example.org/MedicinalProductDefinition/Enbrel425Part1Definition

Resource MedicinalProductDefinition:

Generated Narrative: MedicinalProductDefinition Enbrel425Part1Definition

identifier: National drug codes/58406-424
MarketingStatuses
- Status DateRange
* active 2003-01-02 --> (ongoing)
name
productName: ENBREL
type: Proprietary Name
name
productName: etanercept
type: Generic Name (Non-Proprietary)

Entry 17 - fullUrl = http://example.org/PackagedProductDefinition/Enbrel425Part1Package

Resource PackagedProductDefinition:

Generated Narrative: PackagedProductDefinition Enbrel425Part1Package

packageFor: MedicinalProductDefinition: identifier = http://hl7.org/fhir/sid/ndc#National drug codes#58406-424
package
identifier: National drug codes/58406-424-01
type: VIAL
Properties
- Type Value[x]
* Combination Product Type Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
containedItem
Items
- Reference
* ManufacturedItemDefinition: status = active; manufacturedDoseForm = INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
amount: 1 mL (Details: UCUM codemL = 'mL')

Entry 18 - fullUrl = http://example.org/RegulatedAuthorization/Enbrel425Part1Marketing

Resource RegulatedAuthorization:

Generated Narrative: RegulatedAuthorization Enbrel425Part1Marketing

identifier: urn:oid:2.16.840.1.113883.3.150/NDA103795
subject: MedicinalProductDefinition: identifier = http://hl7.org/fhir/sid/ndc#National drug codes#58406-424
type: NDA
region: United States of America

Entry 19 - fullUrl = http://example.org/MedicinalProductDefinition/Enbrel425Part2Definition

Resource MedicinalProductDefinition:

Generated Narrative: MedicinalProductDefinition Enbrel425Part2Definition

identifier: National drug codes/58406-910
MarketingStatuses
- Status DateRange
* active 2003-01-02 --> (ongoing)
name
productName: ENBREL
type: Proprietary Name
name
productName: etanercept
type: Generic Name (Non-Proprietary)

Entry 20 - fullUrl = http://example.org/PackagedProductDefinition/Enbrel425Part2Package

Resource PackagedProductDefinition:

Generated Narrative: PackagedProductDefinition Enbrel425Part2Package

packageFor: MedicinalProductDefinition: identifier = http://hl7.org/fhir/sid/ndc#National drug codes#58406-910
package
identifier: National drug codes/58406-910-01
type: SYRINGE
Properties
- Type Value[x]
* Combination Product Type Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
containedItem
Items
- Reference
* ManufacturedItemDefinition: status = active; manufacturedDoseForm = SOLUTION
amount: 1 mL (Details: UCUM codemL = 'mL')

Entry 21 - fullUrl = http://example.org/RegulatedAuthorization/Enbrel425Part2Marketing

Resource RegulatedAuthorization:

Generated Narrative: RegulatedAuthorization Enbrel425Part2Marketing

identifier: urn:oid:2.16.840.1.113883.3.150/NDA103795
subject: MedicinalProductDefinition: identifier = http://hl7.org/fhir/sid/ndc#National drug codes#58406-910
type: NDA
region: United States of America

Entry 22 - fullUrl = http://example.org/ManufacturedItemDefinition/EnbrelPowder

Resource ManufacturedItemDefinition:

Generated Narrative: ManufacturedItemDefinition EnbrelPowder

status: Active
manufacturedDoseForm: INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

Entry 23 - fullUrl = http://example.org/Ingredient/EnbrelPowderActiveIngredient

Resource Ingredient:

Generated Narrative: Ingredient EnbrelPowderActiveIngredient

status: Active
for: ManufacturedItemDefinition: status = active; manufacturedDoseForm = INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
role: active ingredient - basis of strength
substance
Codes
- Reference
* SubstanceDefinition: identifier = http://fdasis.nlm.nih.gov#Unique Ingredient Identifier (UNII)#OP401G7OJC
Strengths
- Presentation[x]
* 25 mg (Details: UCUM codemg = 'mg')/1 mL (Details: UCUM codemL = 'mL')

Entry 24 - fullUrl = http://example.org/Ingredient/EnbrelPowderIngredient1

Resource Ingredient:

Generated Narrative: Ingredient EnbrelPowderIngredient1

status: Active
for: ManufacturedItemDefinition: status = active; manufacturedDoseForm = INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
role: inactive ingredient
substance
Codes
- Concept
* MANNITOL
Strengths
- Presentation[x]
* 40 mg (Details: UCUM codemg = 'mg')/1 mL (Details: UCUM codemL = 'mL')

Entry 25 - fullUrl = http://example.org/Ingredient/EnbrelPowderIngredient2

Resource Ingredient:

Generated Narrative: Ingredient EnbrelPowderIngredient2

status: Active
for: ManufacturedItemDefinition: status = active; manufacturedDoseForm = INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
role: inactive ingredient
substance
Codes
- Concept
* SUCROSE
Strengths
- Presentation[x]
* 10 mg (Details: UCUM codemg = 'mg')/1 mL (Details: UCUM codemL = 'mL')

Entry 26 - fullUrl = http://example.org/Ingredient/EnbrelPowderIngredient3

Resource Ingredient:

Generated Narrative: Ingredient EnbrelPowderIngredient3

status: Active
for: ManufacturedItemDefinition: status = active; manufacturedDoseForm = INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
role: inactive ingredient
substance
Codes
- Concept
* TROMETHAMINE
Strengths
- Presentation[x]
* 1.2 mg (Details: UCUM codemg = 'mg')/1 mL (Details: UCUM codemL = 'mL')

Entry 27 - fullUrl = http://example.org/ManufacturedItemDefinition/EnbrelSterileSolution

Resource ManufacturedItemDefinition:

Generated Narrative: ManufacturedItemDefinition EnbrelSterileSolution

status: Active
manufacturedDoseForm: SOLUTION

Entry 28 - fullUrl = http://example.org/Ingredient/EnbrelSterileSolutionIngredient1

Resource Ingredient:

Generated Narrative: Ingredient EnbrelSterileSolutionIngredient1

status: Active
for: ManufacturedItemDefinition: status = active; manufacturedDoseForm = SOLUTION
role: inactive ingredient
substance
Codes
- Concept
* BENZYL ALCOHOL
Strengths
- Presentation[x]
* 9.93 mg (Details: UCUM codemg = 'mg')/1 mL (Details: UCUM codemL = 'mL')

Entry 29 - fullUrl = http://example.org/Ingredient/EnbrelSterileSolutionIngredient2

Resource Ingredient:

Generated Narrative: Ingredient EnbrelSterileSolutionIngredient2

status: Active
for: ManufacturedItemDefinition: status = active; manufacturedDoseForm = SOLUTION
role: inactive ingredient
substance
Codes
- Concept
* WATER
Strengths
- Presentation[x]
* 1 mL (Details: UCUM codemL = 'mL')/1 mL (Details: UCUM codemL = 'mL')

Entry 30 - fullUrl = http://example.org/ManufacturedItemDefinition/EnbrelKit

Resource ManufacturedItemDefinition:

Generated Narrative: ManufacturedItemDefinition EnbrelKit

status: Active
manufacturedDoseForm: KIT

Entry 31 - fullUrl = http://example.org/PackagedProductDefinition/Enbrel425Package

Resource PackagedProductDefinition:

Generated Narrative: PackagedProductDefinition Enbrel425Package

packageFor: MedicinalProductDefinition: identifier = http://hl7.org/fhir/sid/ndc#National drug codes#58406-425
MarketingStatuses
- Status DateRange
* active 2003-10-02 --> (ongoing)
package
identifier: National drug codes/58406-425-34
type: CARTON
package

Entry 32 - fullUrl = http://example.org/RegulatedAuthorization/Enbrel425Marketing

Resource RegulatedAuthorization:

Generated Narrative: RegulatedAuthorization Enbrel425Marketing

identifier: urn:oid:2.16.840.1.113883.3.150/NDA103795
subject: MedicinalProductDefinition: identifier = http://hl7.org/fhir/sid/ndc#National drug codes#58406-425
type: NDA
region: United States of America

Entry 33 - fullUrl = http://example.org/MedicinalProductDefinition/Enbrel455Definition

Resource MedicinalProductDefinition:

Generated Narrative: MedicinalProductDefinition Enbrel455Definition

identifier: National drug codes/58406-455
route: SUBCUTANEOUS
MarketingStatuses
- Status DateRange
* active 2005-11-10 --> (ongoing)
name
productName: ENBREL
type: Proprietary Name
name
productName: etanercept
type: Generic Name (Non-Proprietary)

Entry 34 - fullUrl = http://example.org/ManufacturedItemDefinition/Enbrel25mgSolution

Resource ManufacturedItemDefinition:

Generated Narrative: ManufacturedItemDefinition Enbrel25mgSolution

status: Active
manufacturedDoseForm: SOLUTION

Entry 35 - fullUrl = http://example.org/Ingredient/Enbrel25mgSolutionActiveIngredient

Resource Ingredient:

Generated Narrative: Ingredient Enbrel25mgSolutionActiveIngredient

status: Active
for: ManufacturedItemDefinition: status = active; manufacturedDoseForm = SOLUTION
role: active ingredient - basis of strength
substance
Codes
- Reference
* SubstanceDefinition: identifier = http://fdasis.nlm.nih.gov#Unique Ingredient Identifier (UNII)#OP401G7OJC
Strengths
- Presentation[x]
* 25 mg (Details: UCUM codemg = 'mg')/0.5 mL (Details: UCUM codemL = 'mL')

Entry 36 - fullUrl = http://example.org/Ingredient/Enbrel25mgSolutionIngredient1

Resource Ingredient:

Generated Narrative: Ingredient Enbrel25mgSolutionIngredient1

status: Active
for: ManufacturedItemDefinition: status = active; manufacturedDoseForm = SOLUTION
role: inactive ingredient
substance
Codes
- Concept
* ARGININE HYDROCHLORIDE
Strengths
- Presentation[x]
* 0.013 mmol (Details: UCUM codemmol = 'mmol')/0.5 mL (Details: UCUM codemL = 'mL')

Entry 37 - fullUrl = http://example.org/Ingredient/Enbrel25mgSolutionIngredient2

Resource Ingredient:

Generated Narrative: Ingredient Enbrel25mgSolutionIngredient2

status: Active
for: ManufacturedItemDefinition: status = active; manufacturedDoseForm = SOLUTION
role: inactive ingredient
substance
Codes
- Concept
* SODIUM CHLORIDE
Strengths
- Presentation[x]
* 0.06 mmol (Details: UCUM codemmol = 'mmol')/0.5 mL (Details: UCUM codemL = 'mL')

Entry 38 - fullUrl = http://example.org/Ingredient/Enbrel25mgSolutionIngredient3

Resource Ingredient:

Generated Narrative: Ingredient Enbrel25mgSolutionIngredient3

status: Active
for: ManufacturedItemDefinition: status = active; manufacturedDoseForm = SOLUTION
role: inactive ingredient
substance
Codes
- Concept
* SUCROSE
Strengths
- Presentation[x]
* 5 mg (Details: UCUM codemg = 'mg')/0.5 mL (Details: UCUM codemL = 'mL')

Entry 39 - fullUrl = http://example.org/PackagedProductDefinition/Enbrel455Package

Resource PackagedProductDefinition:

Generated Narrative: PackagedProductDefinition Enbrel455Package

packageFor: MedicinalProductDefinition: identifier = http://hl7.org/fhir/sid/ndc#National drug codes#58406-455; route = SUBCUTANEOUS
MarketingStatuses
- Status DateRange
* active 2005-11-10 --> (ongoing)
package
identifier: National drug codes/58406-455-04
type: CARTON
Properties
- Type Value[x]
* Combination Product Type Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
package

Entry 40 - fullUrl = http://example.org/RegulatedAuthorization/Enbrel455Marketing

Resource RegulatedAuthorization:

Generated Narrative: RegulatedAuthorization Enbrel455Marketing

identifier: urn:oid:2.16.840.1.113883.3.150/NDA103795
subject: MedicinalProductDefinition: identifier = http://hl7.org/fhir/sid/ndc#National drug codes#58406-455; route = SUBCUTANEOUS
type: NDA
region: United States of America

Entry 41 - fullUrl = http://example.org/MedicinalProductDefinition/Enbrel456Definition

Resource MedicinalProductDefinition:

Generated Narrative: MedicinalProductDefinition Enbrel456Definition

identifier: National drug codes/58406-456
route: SUBCUTANEOUS
MarketingStatuses
- Status DateRange
* active 2017-09-29 --> (ongoing)
name
productName: ENBREL
type: Proprietary Name
name
productName: etanercept
type: Generic Name (Non-Proprietary)

Entry 42 - fullUrl = http://example.org/PackagedProductDefinition/Enbrel456Package

Resource PackagedProductDefinition:

Generated Narrative: PackagedProductDefinition Enbrel456Package

packageFor: MedicinalProductDefinition: identifier = http://hl7.org/fhir/sid/ndc#National drug codes#58406-456; route = SUBCUTANEOUS
MarketingStatuses
- Status DateRange
* active 2017-09-29 --> (ongoing)
package
identifier: National drug codes/58406-456-04
type: CARTON
Properties
- Type Value[x]
* Combination Product Type Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
package

Entry 43 - fullUrl = http://example.org/RegulatedAuthorization/Enbrel456Marketing

Resource RegulatedAuthorization:

Generated Narrative: RegulatedAuthorization Enbrel456Marketing

identifier: urn:oid:2.16.840.1.113883.3.150/NDA103795
subject: MedicinalProductDefinition: identifier = http://hl7.org/fhir/sid/ndc#National drug codes#58406-456; route = SUBCUTANEOUS
type: NDA
region: United States of America

Entry 44 - fullUrl = http://example.org/MedicinalProductDefinition/Enbrel446Definition

Resource MedicinalProductDefinition:

Generated Narrative: MedicinalProductDefinition Enbrel446Definition

identifier: National drug codes/58406-446
route: SUBCUTANEOUS
MarketingStatuses
- Status DateRange
* active 2017-10-20 --> (ongoing)
name
productName: ENBREL
type: Proprietary Name
name
productName: etanercept
type: Generic Name (Non-Proprietary)

Entry 45 - fullUrl = http://example.org/PackagedProductDefinition/Enbrel446Package

Resource PackagedProductDefinition:

Generated Narrative: PackagedProductDefinition Enbrel446Package

packageFor: MedicinalProductDefinition: identifier = http://hl7.org/fhir/sid/ndc#National drug codes#58406-446; route = SUBCUTANEOUS
MarketingStatuses
- Status DateRange
* active 2017-10-20 --> (ongoing)
package
identifier: National drug codes/58406-446-04
type: CARTON
Properties
- Type Value[x]
* Combination Product Type Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
package

Entry 46 - fullUrl = http://example.org/RegulatedAuthorization/Enbrel446Marketing

Resource RegulatedAuthorization:

Generated Narrative: RegulatedAuthorization Enbrel446Marketing

identifier: urn:oid:2.16.840.1.113883.3.150/NDA103795
subject: MedicinalProductDefinition: identifier = http://hl7.org/fhir/sid/ndc#National drug codes#58406-446; route = SUBCUTANEOUS
type: NDA
region: United States of America

Entry 47 - fullUrl = http://example.org/MedicinalProductDefinition/Enbrel021Definition

Resource MedicinalProductDefinition:

Generated Narrative: MedicinalProductDefinition Enbrel021Definition

identifier: National drug codes/58406-021
route: SUBCUTANEOUS
MarketingStatuses
- Status DateRange
* active 2019-06-07 --> (ongoing)
name
productName: ENBREL
type: Proprietary Name
name
productName: etanercept
type: Generic Name (Non-Proprietary)

Entry 48 - fullUrl = http://example.org/PackagedProductDefinition/Enbrel021Package

Resource PackagedProductDefinition:

Generated Narrative: PackagedProductDefinition Enbrel021Package

packageFor: MedicinalProductDefinition: identifier = http://hl7.org/fhir/sid/ndc#National drug codes#58406-021; route = SUBCUTANEOUS
MarketingStatuses
- Status DateRange
* active 2019-06-07 --> (ongoing)
package
identifier: National drug codes/58406-021-04
type: CARTON
Properties
- Type Value[x]
* Combination Product Type Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
package

Entry 49 - fullUrl = http://example.org/RegulatedAuthorization/Enbrel021Marketing

Resource RegulatedAuthorization:

Generated Narrative: RegulatedAuthorization Enbrel021Marketing

identifier: urn:oid:2.16.840.1.113883.3.150/NDA103795
subject: MedicinalProductDefinition: identifier = http://hl7.org/fhir/sid/ndc#National drug codes#58406-021; route = SUBCUTANEOUS
type: NDA
region: United States of America

Entry 50 - fullUrl = http://example.org/MedicinalProductDefinition/Enbrel032Definition

Resource MedicinalProductDefinition:

Generated Narrative: MedicinalProductDefinition Enbrel032Definition

identifier: National drug codes/58406-032
route: SUBCUTANEOUS
MarketingStatuses
- Status DateRange
* active 2019-06-07 --> (ongoing)
name
productName: ENBREL
type: Proprietary Name
name
productName: etanercept
type: Generic Name (Non-Proprietary)

Entry 51 - fullUrl = http://example.org/PackagedProductDefinition/Enbrel032Package

Resource PackagedProductDefinition:

Generated Narrative: PackagedProductDefinition Enbrel032Package

packageFor: MedicinalProductDefinition: identifier = http://hl7.org/fhir/sid/ndc#National drug codes#58406-032; route = SUBCUTANEOUS
MarketingStatuses
- Status DateRange
* active 2019-06-07 --> (ongoing)
package
identifier: National drug codes/58406-032-04
type: CARTON
Properties
- Type Value[x]
* Combination Product Type Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
package

Entry 52 - fullUrl = http://example.org/RegulatedAuthorization/Enbrel032Marketing

Resource RegulatedAuthorization:

Generated Narrative: RegulatedAuthorization Enbrel032Marketing

identifier: urn:oid:2.16.840.1.113883.3.150/NDA103795
subject: MedicinalProductDefinition: identifier = http://hl7.org/fhir/sid/ndc#National drug codes#58406-032; route = SUBCUTANEOUS
type: NDA
region: United States of America

Entry 53 - fullUrl = http://example.org/MedicinalProductDefinition/Enbrel010Definition

Resource MedicinalProductDefinition:

Generated Narrative: MedicinalProductDefinition Enbrel010Definition

identifier: National drug codes/58406-010
route: SUBCUTANEOUS
MarketingStatuses
- Status DateRange
* active 2019-06-07 --> (ongoing)
name
productName: ENBREL
type: Proprietary Name
name
productName: etanercept
type: Generic Name (Non-Proprietary)

Entry 54 - fullUrl = http://example.org/PackagedProductDefinition/Enbrel010Package

Resource PackagedProductDefinition:

Generated Narrative: PackagedProductDefinition Enbrel010Package

packageFor: MedicinalProductDefinition: identifier = http://hl7.org/fhir/sid/ndc#National drug codes#58406-010; route = SUBCUTANEOUS
MarketingStatuses
- Status DateRange
* active 2019-06-07 --> (ongoing)
package
identifier: National drug codes/58406-010-04
type: CARTON
Properties
- Type Value[x]
* Combination Product Type Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
package

Entry 55 - fullUrl = http://example.org/RegulatedAuthorization/Enbrel010Marketing

Resource RegulatedAuthorization:

Generated Narrative: RegulatedAuthorization Enbrel010Marketing

identifier: urn:oid:2.16.840.1.113883.3.150/NDA103795
subject: MedicinalProductDefinition: identifier = http://hl7.org/fhir/sid/ndc#National drug codes#58406-010; route = SUBCUTANEOUS
type: NDA
region: United States of America

Entry 56 - fullUrl = http://example.org/MedicinalProductDefinition/Enbrel044Definition

Resource MedicinalProductDefinition:

Generated Narrative: MedicinalProductDefinition Enbrel044Definition

identifier: National drug codes/58406-044
route: SUBCUTANEOUS
MarketingStatuses
- Status DateRange
* active 2019-06-07 --> (ongoing)
name
productName: ENBREL
type: Proprietary Name
name
productName: etanercept
type: Generic Name (Non-Proprietary)

Entry 57 - fullUrl = http://example.org/PackagedProductDefinition/Enbrel044Package

Resource PackagedProductDefinition:

Generated Narrative: PackagedProductDefinition Enbrel044Package

packageFor: MedicinalProductDefinition: identifier = http://hl7.org/fhir/sid/ndc#National drug codes#58406-044; route = SUBCUTANEOUS
MarketingStatuses
- Status DateRange
* active 2019-06-07 --> (ongoing)
package
identifier: National drug codes/58406-044-04
type: CARTON
Properties
- Type Value[x]
* Combination Product Type Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
package

Entry 58 - fullUrl = http://example.org/RegulatedAuthorization/Enbrel044Marketing

Resource RegulatedAuthorization:

Generated Narrative: RegulatedAuthorization Enbrel044Marketing

identifier: urn:oid:2.16.840.1.113883.3.150/NDA103795
subject: MedicinalProductDefinition: identifier = http://hl7.org/fhir/sid/ndc#National drug codes#58406-044; route = SUBCUTANEOUS
type: NDA
region: United States of America

Entry 59 - fullUrl = http://example.org/MedicinalProductDefinition/Enbrel055Definition

Resource MedicinalProductDefinition:

Generated Narrative: MedicinalProductDefinition Enbrel055Definition

identifier: National drug codes/58406-055
route: SUBCUTANEOUS
MarketingStatuses
- Status DateRange
* active 2020-03-05 --> (ongoing)
name
productName: ENBREL
type: Proprietary Name
name
productName: etanercept
type: Generic Name (Non-Proprietary)

Entry 60 - fullUrl = http://example.org/PackagedProductDefinition/Enbrel055Package

Resource PackagedProductDefinition:

Generated Narrative: PackagedProductDefinition Enbrel055Package

packageFor: MedicinalProductDefinition: identifier = http://hl7.org/fhir/sid/ndc#National drug codes#58406-055; route = SUBCUTANEOUS
MarketingStatuses
- Status DateRange
* active 2020-03-05 --> (ongoing)
package
identifier: National drug codes/58406-055-04
type: CARTON
Properties
- Type Value[x]
* Combination Product Type Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
package

Entry 61 - fullUrl = http://example.org/RegulatedAuthorization/Enbrel055Marketing

Resource RegulatedAuthorization:

Generated Narrative: RegulatedAuthorization Enbrel055Marketing

identifier: urn:oid:2.16.840.1.113883.3.150/NDA103795
subject: MedicinalProductDefinition: identifier = http://hl7.org/fhir/sid/ndc#National drug codes#58406-055; route = SUBCUTANEOUS
type: NDA
region: United States of America