Pharmaceutical Quality Submissions to Food & Drug Administration (PQ/CMC), published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 0.1.20 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/ and changes regularly. See the Directory of published versions
<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></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 "5772a6f2-cde1-4903-bfcf-1639340205cc" </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">Dummy NCIT Codesystem</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">Dummy NCIT Codesystem</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/5.3.0/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/5.3.0/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/5.3.0/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/5.3.0/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>
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<part>
<part value="ACETAMINOPHEN"/>
<type>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2"/>
<code value="SCI"/>
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</type>
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<part>
<part value="300mg"/>
<type>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2"/>
<code value="STR"/>
</coding>
</type>
</part>
</name>
</MedicinalProductDefinition>