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

: DrugProductComponent example for an excipient - Maize starch - XML Representation

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<Ingredient xmlns="http://hl7.org/fhir">
  <id value="d01421cc-6488-468b-a676-d3e7281875e2"/>
  <meta>
    <profile
             value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-component"/>
  </meta>
  <text>
    <status value="generated"/>
    <div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: Ingredient</b><a name="d01421cc-6488-468b-a676-d3e7281875e2"> </a><a name="hcd01421cc-6488-468b-a676-d3e7281875e2"> </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 Ingredient &quot;d01421cc-6488-468b-a676-d3e7281875e2&quot; </p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-pqcmc-component.html">Drug Product Component</a></p></div><p><b>status</b>: draft</p><p><b>role</b>: Inactive Ingredient <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C42637)</span></p><blockquote><p><b>substance</b></p><h3>Codes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Reference</b></td></tr><tr><td style="display: none">*</td><td><a href="Bundle-bd0f0a7a-27ea-4884-801d-bd0546e80888.html#urn-uuid-393a14e7-3edc-4373-bbe5-9e569d504a1c">urn:uuid:393a14e7-3edc-4373-bbe5-9e569d504a1c</a></td></tr></table><h3>Strengths</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Extension</b></td><td><b>Presentation[x]</b></td><td><b>TextPresentation</b></td></tr><tr><td style="display: none">*</td><td/><td>700 mg<span style="background: LightGoldenRodYellow"> (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C28253 = 'mg')</span>/1 [arb'U]<span style="background: LightGoldenRodYellow"> (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C75765 = '[arb'U]')</span></td><td>700mg</td></tr></table></blockquote></div>
  </text>
  <status value="draft"/>
  <role>
    <coding>
      <system
              value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
      <code value="C42637"/>
      <display value="Inactive Ingredient"/>
    </coding>
  </role>
  <substance>
    <code>
      <reference>
        <reference value="urn:uuid:393a14e7-3edc-4373-bbe5-9e569d504a1c"/>
      </reference>
    </code>
    <strength>
      <extension
                 url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/strength-extension">
        <extension url="strengthType">
          <valueCodeableConcept>
            <coding>
              <system
                      value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
              <code value="C168628"/>
              <display value="Mass"/>
            </coding>
          </valueCodeableConcept>
        </extension>
        <extension url="contentPercent">
          <valueDecimal value="0.5828"/>
        </extension>
      </extension>
      <presentationRatio>
        <numerator>
          <value value="700"/>
          <unit value="mg"/>
          <system
                  value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
          <code value="C28253"/>
        </numerator>
        <denominator>
          <value value="1"/>
          <unit value="[arb'U]"/>
          <system
                  value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
          <code value="C75765"/>
        </denominator>
      </presentationRatio>
      <textPresentation value="700mg"/>
    </strength>
  </substance>
</Ingredient>