Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
2.0.0 - STU2

Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 2.0.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/FHIR-us-pq-cmc-fda/ and changes regularly. See the Directory of published versions

## : Substance Name Type - XML Representation

Page standards status: Trial-use | Maturity Level: 2

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    <ValueSet xmlns="http://hl7.org/fhir">
      <id value="pqcmc-substance-name-type"/>
      <text>
        <status value="generated"/>
        <div xmlns="http://www.w3.org/1999/xhtml"><p class="res-header-id"><b>Generated Narrative: ValueSet pqcmc-substance-name-type</b></p><a name="pqcmc-substance-name-type"> </a><a name="hcpqcmc-substance-name-type"> </a><ul><li>Include these codes as defined in <a href="http://terminology.hl7.org/6.4.0/CodeSystem-v3-nciThesaurus.html"><code>http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl</code></a><table class="none"><tr><td style="white-space:nowrap"><b>Code</b></td><td><b>Display</b></td></tr><tr><td>C71898</td><td>Brand</td></tr><tr><td>C97054</td><td>Generic Name</td></tr><tr><td>C203355</td><td>GSRS Preferred Term</td></tr><tr><td>C203357</td><td>Systematic Name</td></tr><tr><td>C203358</td><td>USP-NF Established Name</td></tr><tr><td>C54682</td><td>CAS Number</td></tr><tr><td>C142585</td><td>INN</td></tr><tr><td>C96973</td><td>USAN</td></tr><tr><td>C203356</td><td>IUPAC Name</td></tr><tr><td>C95517</td><td>ISBT-128 DIN</td></tr><tr><td>C203354</td><td>Company ID/Code</td></tr></table></li></ul></div>
      </text>
      <extension
                 url="http://hl7.org/fhir/StructureDefinition/structuredefinition-wg">
        <valueCode value="brr"/>
      </extension>
      <extension
                 url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm">
        <valueInteger value="2">
          <extension
                     url="http://hl7.org/fhir/StructureDefinition/structuredefinition-conformance-derivedFrom">
            <valueCanonical
                            value="http://hl7.org/fhir/us/pq-cmc-fda/ImplementationGuide/hl7.fhir.us.pq-cmc-fda"/>
          </extension>
        </valueInteger>
      </extension>
      <extension
                 url="http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status">
        <valueCode value="trial-use">
          <extension
                     url="http://hl7.org/fhir/StructureDefinition/structuredefinition-conformance-derivedFrom">
            <valueCanonical
                            value="http://hl7.org/fhir/us/pq-cmc-fda/ImplementationGuide/hl7.fhir.us.pq-cmc-fda"/>
          </extension>
        </valueCode>
      </extension>
      <url
           value="http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-substance-name-type"/>
      <identifier>
        <system value="urn:ietf:rfc:3986"/>
        <value value="urn:oid:2.16.840.1.113883.4.642.40.36.48.27"/>
      </identifier>
      <version value="2.0.0"/>
      <name value="PqcmcSubstanceNameType"/>
      <title value="Substance Name Type"/>
      <status value="active"/>
      <experimental value="false"/>
      <date value="2025-07-03T13:07:08+00:00"/>
      <publisher value="HL7 International / Biomedical Research and Regulation"/>
      <contact>
        <name value="HL7 International / Biomedical Research and Regulation"/>
        <telecom>
          <system value="url"/>
          <value value="http://www.hl7.org/Special/committees/rcrim"/>
        </telecom>
        <telecom>
          <system value="email"/>
          <value value="brr@lists.HL7.org"/>
        </telecom>
      </contact>
      <description
                   value="A category of terminology used to qualify the information pertaining to the type of substance name in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents."/>
      <jurisdiction>
        <coding>
          <system value="urn:iso:std:iso:3166"/>
          <code value="US"/>
          <display value="United States of America"/>
        </coding>
      </jurisdiction>
      <compose>
        <include>
          <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
          <concept>
            <code value="C71898"/>
            <display value="Brand"/>
          </concept>
          <concept>
            <code value="C97054"/>
            <display value="Generic Name"/>
          </concept>
          <concept>
            <code value="C203355"/>
            <display value="GSRS Preferred Term"/>
          </concept>
          <concept>
            <code value="C203357"/>
            <display value="Systematic Name"/>
          </concept>
          <concept>
            <code value="C203358"/>
            <display value="USP-NF Established Name"/>
          </concept>
          <concept>
            <code value="C54682"/>
            <display value="CAS Number"/>
          </concept>
          <concept>
            <code value="C142585"/>
            <display value="INN"/>
          </concept>
          <concept>
            <code value="C96973"/>
            <display value="USAN"/>
          </concept>
          <concept>
            <code value="C203356"/>
            <display value="IUPAC Name"/>
          </concept>
          <concept>
            <code value="C95517"/>
            <display value="ISBT-128 DIN"/>
          </concept>
          <concept>
            <code value="C203354"/>
            <display value="Company ID/Code"/>
          </concept>
        </include>
      </compose>
    </ValueSet>