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 - acetaminophen

Generated Narrative: SubstanceDefinition

Resource SubstanceDefinition "fc878c4f-a98c-427c-816b-e03ccdf0e712"

Profile: Component Substance

identifier: acetaminophen

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
*362O9ITL9D (Unique Ingredient Identifier (UNII)#362O9ITL9D)

Names

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

SourceMaterials

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