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

: A DrugProductDescription for a multilayer product - XML Representation

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<MedicinalProductDefinition xmlns="http://hl7.org/fhir">
  <id value="5772a6f2-cde1-4903-bfcf-1639340205cc"/>
  <meta>
    <profile
             value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-drug-product-description"/>
  </meta>
  <text>
    <status value="generated"/>
    <div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: MedicinalProductDefinition</b><a name="5772a6f2-cde1-4903-bfcf-1639340205cc"> </a><a name="hc5772a6f2-cde1-4903-bfcf-1639340205cc"> </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 MedicinalProductDefinition &quot;5772a6f2-cde1-4903-bfcf-1639340205cc&quot; </p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-pqcmc-drug-product-description.html">Drug Product Description</a></p></div><p><b>description</b>: A tablet consisting of two layers where one provides immediate release and  of the two drugs (Figure in 3.2.P.1.3). Both immediate-release layers are composed of granules with a matrix layer for the modified release of the drug.</p><p><b>combinedPharmaceuticalDoseForm</b>: TABLET, MULTILAYER <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C42964)</span></p><p><b>route</b>: ORAL <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C38288)</span></p><blockquote><p><b>name</b></p><p><b>productName</b>: ASPIRIN 200mg, ACETAMINOPHEN 300mg</p><p><b>type</b>: Non-Proprietary <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-product-name-types.html">Product Name Types Code Types</a>#NON)</span></p><blockquote><p><b>part</b></p><p><b>part</b>: ASPIRIN</p><p><b>type</b>: scientific name <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.5.0/CodeSystem-v3-EntityNamePartQualifierR2.html">EntityNamePartQualifierR2</a>#SCI)</span></p></blockquote><blockquote><p><b>part</b></p><p><b>part</b>: 200mg</p><p><b>type</b>: strength name <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.5.0/CodeSystem-v3-EntityNamePartQualifierR2.html">EntityNamePartQualifierR2</a>#STR)</span></p></blockquote><blockquote><p><b>part</b></p><p><b>part</b>: ACETAMINOPHEN</p><p><b>type</b>: scientific name <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.5.0/CodeSystem-v3-EntityNamePartQualifierR2.html">EntityNamePartQualifierR2</a>#SCI)</span></p></blockquote><blockquote><p><b>part</b></p><p><b>part</b>: 300mg</p><p><b>type</b>: strength name <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.5.0/CodeSystem-v3-EntityNamePartQualifierR2.html">EntityNamePartQualifierR2</a>#STR)</span></p></blockquote></blockquote></div>
  </text>
  <description
               value="A tablet consisting of two layers where one provides immediate release and  of the two drugs (Figure in 3.2.P.1.3). Both immediate-release layers are composed of granules with a matrix layer for the modified release of the drug."/>
  <combinedPharmaceuticalDoseForm>
    <coding>
      <system
              value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
      <code value="C42964"/>
      <display value="TABLET, MULTILAYER"/>
    </coding>
  </combinedPharmaceuticalDoseForm>
  <route>
    <coding>
      <system
              value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
      <code value="C38288"/>
      <display value="ORAL"/>
    </coding>
  </route>
  <name>
    <productName value="ASPIRIN 200mg, ACETAMINOPHEN 300mg"/>
    <type>
      <coding>
        <system
                value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-product-name-types"/>
        <code value="NON"/>
        <display value="Non-Proprietary"/>
      </coding>
      <text value="Non-Proprietary"/>
    </type>
    <part>
      <part value="ASPIRIN"/>
      <type>
        <coding>
          <system
                  value="http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2"/>
          <code value="SCI"/>
        </coding>
      </type>
    </part>
    <part>
      <part value="200mg"/>
      <type>
        <coding>
          <system
                  value="http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2"/>
          <code value="STR"/>
        </coding>
      </type>
    </part>
    <part>
      <part value="ACETAMINOPHEN"/>
      <type>
        <coding>
          <system
                  value="http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2"/>
          <code value="SCI"/>
        </coding>
      </type>
    </part>
    <part>
      <part value="300mg"/>
      <type>
        <coding>
          <system
                  value="http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2"/>
          <code value="STR"/>
        </coding>
      </type>
    </part>
  </name>
</MedicinalProductDefinition>