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 1.1.2 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
<MedicinalProductDefinition xmlns="http://hl7.org/fhir">
<id value="ddd3abad-347c-4d2f-95f3-dd804e250502"/>
<meta>
<profile
value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-drug-product-with-impurities"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: MedicinalProductDefinition </b><a name="ddd3abad-347c-4d2f-95f3-dd804e250502"> </a><a name="hcddd3abad-347c-4d2f-95f3-dd804e250502"> </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">ResourceMedicinalProductDefinition "ddd3abad-347c-4d2f-95f3-dd804e250502" </p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-pqcmc-drug-product-with-impurities.html">Drug Product Impurities</a></p></div><p><b>identifier</b>: TabletCoatedBeadsCoatedAll</p><p><b>description</b>: A drug product composed of one type of bead with two coatings inside a coated tablet</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><h3>Impurities</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-9e8f2d16-66b1-47ec-878d-f50ae021985b.html#urn-uuid-58ae52aa-c81e-415a-8791-e67a3195290d">urn:uuid:58ae52aa-c81e-415a-8791-e67a3195290d</a></td></tr><tr><td style="display: none">*</td><td><a href="Bundle-9e8f2d16-66b1-47ec-878d-f50ae021985b.html#urn-uuid-ffa30c0b-8031-436a-87f1-635b3bbe5989">urn:uuid:ffa30c0b-8031-436a-87f1-635b3bbe5989</a></td></tr></table><blockquote><p><b>name</b></p><p><b>productName</b>: LEVOTHYROXINE SODIUM ANHYDROUS 125mg</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>: LEVOTHYROXINE SODIUM ANHYDROUS</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>: 125mg</p><p><b>type</b>: LEVOTHYROXINE SODIUM ANHYDROUS <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>
<identifier>
<value value="TabletCoatedBeadsCoatedAll"/>
</identifier>
<description
value="A drug product composed of one type of bead with two coatings inside a coated tablet"/>
<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>
<impurity>
<reference>
<reference value="urn:uuid:58ae52aa-c81e-415a-8791-e67a3195290d"/>
</reference>
</impurity>
<impurity>
<reference>
<reference value="urn:uuid:ffa30c0b-8031-436a-87f1-635b3bbe5989"/>
</reference>
</impurity>
<name>
<productName value="LEVOTHYROXINE SODIUM ANHYDROUS 125mg"/>
<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="LEVOTHYROXINE SODIUM ANHYDROUS"/>
<type>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2"/>
<code value="SCI"/>
</coding>
</type>
</part>
<part>
<part value="125mg"/>
<type>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2"/>
<code value="STR"/>
</coding>
<text value="LEVOTHYROXINE SODIUM ANHYDROUS"/>
</type>
</part>
</name>
</MedicinalProductDefinition>