Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
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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 RoutineSubstanceDefinition - IBUPROFEN - XML Representation

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<SubstanceDefinition xmlns="http://hl7.org/fhir">
  <id value="580c28ac-1a2c-49fa-9be3-de997da5edcf"/>
  <meta>
    <profile
             value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-routine-drug-substance"/>
  </meta>
  <text>
    <status value="generated"/>
    <div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: SubstanceDefinition</b><a name="580c28ac-1a2c-49fa-9be3-de997da5edcf"> </a><a name="hc580c28ac-1a2c-49fa-9be3-de997da5edcf"> </a></p><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">Resource SubstanceDefinition &quot;580c28ac-1a2c-49fa-9be3-de997da5edcf&quot; </p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-pqcmc-routine-drug-substance.html">Routine Drug Substance</a></p></div><p><b>identifier</b>: P-Isobutylhydratropic Acid</p><p><b>classification</b>: Chemical <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C48807)</span></p><p><b>grade</b>: USP-NF <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C134006)</span></p><p><b>manufacturer</b>: <a href="Bundle-6004e36e-7df9-469d-9b29-8e9f9bd7e95f.html#urn-uuid-e99bddfa-c1b5-435b-bbe8-24816b4e23e5">urn:uuid:e99bddfa-c1b5-435b-bbe8-24816b4e23e5</a></p><p><b>supplier</b>: <a href="Bundle-6004e36e-7df9-469d-9b29-8e9f9bd7e95f.html#urn-uuid-d9e7c2f7-0f59-4645-bb6d-5a8dd2425049">urn:uuid:d9e7c2f7-0f59-4645-bb6d-5a8dd2425049</a></p><h3>Codes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Code</b></td></tr><tr><td style="display: none">*</td><td>WK2XYI10QM <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.5.0/CodeSystem-UNII.html">Unique Ingredient Identifier (UNII)</a>#WK2XYI10QM)</span></td></tr></table><h3>Names</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Name</b></td><td><b>Type</b></td><td><b>Preferred</b></td></tr><tr><td style="display: none">*</td><td>IBUPROFENPIRIN</td><td>GSRS Preferred Term <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C203355)</span></td><td>true</td></tr></table></div>
  </text>
  <identifier>
    <value value="P-Isobutylhydratropic Acid"/>
  </identifier>
  <classification>
    <coding>
      <system
              value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
      <code value="C48807"/>
      <display value="Chemical"/>
    </coding>
  </classification>
  <grade>
    <coding>
      <system
              value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
      <code value="C134006"/>
      <display value="USP-NF"/>
    </coding>
  </grade>
  <manufacturer>
    <reference value="urn:uuid:e99bddfa-c1b5-435b-bbe8-24816b4e23e5"/>
  </manufacturer>
  <supplier>
    <reference value="urn:uuid:d9e7c2f7-0f59-4645-bb6d-5a8dd2425049"/>
  </supplier>
  <code>
    <code>
      <coding>
        <system value="http://fdasis.nlm.nih.gov"/>
        <code value="WK2XYI10QM"/>
      </coding>
    </code>
  </code>
  <name>
    <name value="IBUPROFENPIRIN"/>
    <type>
      <coding>
        <system
                value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
        <code value="C203355"/>
        <display value="GSRS Preferred Term"/>
      </coding>
    </type>
    <preferred value="true"/>
  </name>
</SubstanceDefinition>