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: Composition ingredient substance indentifying information - aspirin

Generated Narrative: SubstanceDefinition

Resource SubstanceDefinition "2d70d504-8cc6-4282-81d4-b20b0a98b78b"

Profile: Component Substance

identifier: aspirin

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

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

manufacturer: urn:uuid:4b565cf3-5353-48af-8cd6-5ccf4e9fd579

supplier: urn:uuid:8ee60ed1-e22f-4d3b-ab08-8986e4e8e1d9

Codes

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

Names

-NameTypePreferred
*ASPIRINGSRS Preferred Term (PQ-CMC-FDA Temporary Codes#C203355)true

SourceMaterials

-Type
*Chemical (PQ-CMC-FDA Temporary Codes#C48807)