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: DrugProductComponent example for an excipient - Maize starch

Generated Narrative: Ingredient

Resource Ingredient "d01421cc-6488-468b-a676-d3e7281875e2"

Profile: Drug Product Component

status: draft

role: Inactive Ingredient (PQ-CMC-FDA Temporary Codes#C42637)

substance

Codes

-Reference
*urn:uuid:393a14e7-3edc-4373-bbe5-9e569d504a1c

Strengths

-ExtensionPresentation[x]TextPresentation
*700 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]')700mg