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 SubstanceDefinition: Example RoutineSubstanceDefinition for Asprin

Generated Narrative: SubstanceDefinition

Resource SubstanceDefinition "cd84a8b5-4e96-551c-15c6-c97c943eb38a"

Profile: Routine Drug Substance

identifier: salicylate

classification: Chemical (PQ-CMC-FDA Temporary Codes#C48807)

grade: USP-NF (PQ-CMC-FDA Temporary Codes#C134006)

manufacturer: urn:uuid:e99bddfa-c1b5-435b-bbe8-24816b4e23e5

Codes

-Code
*R16CO5Y76E (Unique Ingredient Identifier (UNII)#R16CO5Y76E)

name

name: ACETYLSALICYLIC ACID

type: Generic Name (PQ-CMC-FDA Temporary Codes#C97054)

name

name: ASPIRIN

type: GSRS Preferred Term (PQ-CMC-FDA Temporary Codes#C203355)

preferred: true