Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
1.0.0-ballot - STU 1-ballot United States of America flag

This page is part of the Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA (v1.0.0-ballot: STU1 Ballot 1) based on FHIR (HL7® FHIR® Standard) v5.0.0. . For a full list of available versions, see the Directory of published versions

Example MedicinalProductDefinition: A DrugProductContainerClosure

Generated Narrative: MedicinalProductDefinition

Resource MedicinalProductDefinition "77ad6922-9c59-43d1-93cb-29d063cc2e8c"

Profile: Drug Product Container Closure

Container Closure

url

containerType

value: BOTTLE (PQ-CMC-FDA Temporary Codes#C43169)

url

closureType

value: Child-resistant, Plastic (PQ-CMC-FDA Temporary Codes#C96114)

url

description

value: a plastic bottle with a child-proof cap

name

productName: ASPIRIN 200mg, ACETAMINOPHEN 300mg

type: Non-Proprietary (Product Name Types Code Types#NON)

part

part: ASPIRIN

type: scientific name (EntityNamePartQualifierR2#SCI)

part

part: 200mg

type: strength name (EntityNamePartQualifierR2#STR)

part

part: ACETAMINOPHEN

type: scientific name (EntityNamePartQualifierR2#SCI)

part

part: 300mg

type: strength name (EntityNamePartQualifierR2#STR)