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 - Grape skin extract

Generated Narrative: Ingredient

Resource Ingredient "3791c4ce-2b43-4d7b-b195-0e5f88f28dab"

Profile: Drug Product Component

status: draft

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

substance

Codes

-Reference
*urn:uuid:496f83ad-2365-4b12-8672-a349d99f7d67

Strengths

-ExtensionPresentation[x]TextPresentation
*1 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]')1mg