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 Ingredient: Strength information for the Active Ingredient - acetaminophen

Generated Narrative: Ingredient

Resource Ingredient "7f10a35e-228d-42db-8918-6ccada78454d"

Profile: Drug Product Component

status: draft

role: Active Ingredient (PQ-CMC-FDA Temporary Codes#C82533)

substance

Codes

-Reference
*urn:uuid:fc878c4f-a98c-427c-816b-e03ccdf0e712

Strengths

-ExtensionPresentation[x]TextPresentation
*300 mg (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C28253 = 'mg')/1 [arb'U] (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C75765 = '[arb'U]')300mg