Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
2.0.0-ballot - STU2 ballot
Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
2.0.0-ballot - STU2 ballot
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 2.0.0-ballot 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
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<div xmlns="http://www.w3.org/1999/xhtml"><a name="Organization_4f3e9af1-306b-4fad-bf04-7881400b266a"> </a><p class="res-header-id"><b>Generated Narrative: Organization 4f3e9af1-306b-4fad-bf04-7881400b266a</b></p><a name="4f3e9af1-306b-4fad-bf04-7881400b266a"> </a><a name="hc4f3e9af1-306b-4fad-bf04-7881400b266a"> </a><a name="4f3e9af1-306b-4fad-bf04-7881400b266a-en-US"> </a><p><b>identifier</b>: DUNS/143265222</p><p><b>name</b>: Wunderwerke</p><h3>Contacts</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Address</b></td></tr><tr><td style="display: none">*</td><td>Wunderwerke, 123 Scenic Road, CT, Bridgeport, USA 65478</td></tr></table></div>
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<div xmlns="http://www.w3.org/1999/xhtml"><a name="MedicinalProductDefinition_f0f3ff35-5cfa-6617-b8f1-b8167957f53c"> </a><p class="res-header-id"><b>Generated Narrative: MedicinalProductDefinition f0f3ff35-5cfa-6617-b8f1-b8167957f53c</b></p><a name="f0f3ff35-5cfa-6617-b8f1-b8167957f53c"> </a><a name="hcf0f3ff35-5cfa-6617-b8f1-b8167957f53c"> </a><a name="f0f3ff35-5cfa-6617-b8f1-b8167957f53c-en-US"> </a><p><b>identifier</b>: ASPIRIN-ACETAMINOPHEN-Identification</p><p><b>combinedPharmaceuticalDoseForm</b>: <span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C42964}">TABLET, MULTILAYER</span></p><p><b>route</b>: <span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C38288}">ORAL</span></p><p><b>comprisedOf</b>: <a href="Bundle-49d3b79e-b436-a242-93ba-b706b4364ab2.html#urn-uuid-8a3e11d9-4323-43c4-be00-8f0ea1837070">Bundle: identifier = UUID:49d3b79e-b436-a242-93ba-b706b4364ab2; type = document; timestamp = 2024-08-29 12:34:56+0000</a></p><blockquote><p><b>name</b></p><p><b>productName</b>: ASPIRIN 200mg, ACETAMINOPHEN 300mg</p><p><b>type</b>: <span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C96971}">Nonproprietary Name</span></p><blockquote><p><b>part</b></p><p><b>part</b>: ASPIRIN</p><p><b>type</b>: <span title="Codes:{http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2 SCI}">scientific name</span></p></blockquote><blockquote><p><b>part</b></p><p><b>part</b>: 200mg</p><p><b>type</b>: <span title="Codes:{http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2 STR}">ASPIRIN</span></p></blockquote><blockquote><p><b>part</b></p><p><b>part</b>: ACETAMINOPHEN</p><p><b>type</b>: <span title="Codes:{http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2 SCI}">scientific name</span></p></blockquote><blockquote><p><b>part</b></p><p><b>part</b>: 300mg</p><p><b>type</b>: <span title="Codes:{http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2 STR}">ACETAMINOPHEN</span></p></blockquote></blockquote></div>
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<fullUrl value="urn:uuid:8a3e11d9-4323-43c4-be00-8f0ea1837070"/>
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<ManufacturedItemDefinition>
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<div xmlns="http://www.w3.org/1999/xhtml"><a name="ManufacturedItemDefinition_8a3e11d9-4323-43c4-be00-8f0ea1837070"> </a><p class="res-header-id"><b>Generated Narrative: ManufacturedItemDefinition 8a3e11d9-4323-43c4-be00-8f0ea1837070</b></p><a name="8a3e11d9-4323-43c4-be00-8f0ea1837070"> </a><a name="hc8a3e11d9-4323-43c4-be00-8f0ea1837070"> </a><a name="8a3e11d9-4323-43c4-be00-8f0ea1837070-en-US"> </a><p><b>identifier</b>: ASPIRIN-ACETAMINOPHEN</p><p><b>status</b>: Active</p><p><b>name</b>: ASPIRIN 200mg, ACETAMINOPHEN 300mg 2000 tablets</p><p><b>manufacturedDoseForm</b>: <span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C154605}">Tablet</span></p><p><b>manufacturer</b>: <a href="Bundle-30536c0e-456c-4f90-9f02-da7be1d289e9.html#urn-uuid-b69435a0-45c6-4d44-9fde-b354e17408d7">Bundle: identifier = UUID:1bf43677-1c61-41dd-93c2-8ec7f327d0f1; type = document; timestamp = 2023-12-15 22:19:47+0000</a></p><blockquote><p><b>property</b></p><p><b>type</b>: <span title="Codes:">Batch Quantity</span></p><p><b>value</b>: 2000 1*<span style="background: LightGoldenRodYellow"> (Details: UCUM code1 = '1')</span></p></blockquote><blockquote><p><b>property</b></p><p><b>type</b>: <span title="Codes:">Batch Utilization</span></p><p><b>value</b>: <span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C133991}">Development</span></p></blockquote><blockquote><p><b>property</b></p><p><b>type</b>: <span title="Codes:">Product Part Additional Information</span></p><p><b>value</b>: </p><div><p>Makes 2000 tablets equivalent to 2.402 kilograms, accounting for losses from evaporation</p>
</div></blockquote><blockquote><p><b>component</b></p><p><b>type</b>: <span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C66831}">Layer</span></p><p><b>amount</b>: 925.97 gram<span style="background: LightGoldenRodYellow"> (Details: UCUM codeg = 'g')</span>, 38.55 percent<span style="background: LightGoldenRodYellow"> (Details: UCUM code% = '%')</span></p><blockquote><p><b>constituent</b></p><p><b>amount</b>: 400 gram<span style="background: LightGoldenRodYellow"> (Details: UCUM codeg = 'g')</span>, 43.1 percent<span style="background: LightGoldenRodYellow"> (Details: UCUM code% = '%')</span></p><p><b>location</b>: <span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C203881}">Purple Layer</span></p><h3>HasIngredients</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-49d3b79e-b436-a242-93ba-b706b4364ab2.html#urn-uuid-d4713a90-38d1-49e5-a977-78c63e518562">Bundle: identifier = UUID:49d3b79e-b436-a242-93ba-b706b4364ab2; type = document; timestamp = 2024-08-29 12:34:56+0000</a></td></tr></table></blockquote><blockquote><p><b>constituent</b></p><p><b>amount</b>: 524.01 gram<span style="background: LightGoldenRodYellow"> (Details: UCUM codeg = 'g')</span>, 56.59 percent<span style="background: LightGoldenRodYellow"> (Details: UCUM code% = '%')</span></p><p><b>location</b>: <span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C203883}">Purple Layer</span></p><h3>HasIngredients</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-49d3b79e-b436-a242-93ba-b706b4364ab2.html#urn-uuid-9973ba9a-b257-425a-8fb9-6dcfe379ca08">Bundle: identifier = UUID:49d3b79e-b436-a242-93ba-b706b4364ab2; type = document; timestamp = 2024-08-29 12:34:56+0000</a></td></tr></table></blockquote><blockquote><p><b>constituent</b></p><p><b>amount</b>: 203.71 gram<span style="background: LightGoldenRodYellow"> (Details: UCUM codeg = 'g')</span>, 22 percent<span style="background: LightGoldenRodYellow"> (Details: UCUM code% = '%')</span></p><p><b>location</b>: <span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C203882}">Purple Layer</span></p><h3>HasIngredients</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-49d3b79e-b436-a242-93ba-b706b4364ab2.html#urn-uuid-4e394a0c-4b25-492e-aac7-0faf121ffc4f">Bundle: identifier = UUID:49d3b79e-b436-a242-93ba-b706b4364ab2; type = document; timestamp = 2024-08-29 12:34:56+0000</a></td></tr></table></blockquote><blockquote><p><b>constituent</b></p><blockquote><p><b>Product Batch Ingredient Extension</b></p><ul><li>overagePercent: 0.02</li><li>overageJustification: </li></ul></blockquote><div><p>Evaporation</p>
</div><p><b>amount</b>: 311.68 gram<span style="background: LightGoldenRodYellow"> (Details: UCUM codeg = 'g')</span>, 33 percent<span style="background: LightGoldenRodYellow"> (Details: UCUM code% = '%')</span></p><p><b>location</b>: <span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C203882}">Purple Layer</span></p><h3>HasIngredients</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-49d3b79e-b436-a242-93ba-b706b4364ab2.html#urn-uuid-95648837-ec81-42d9-970c-eac390f2f604">Bundle: identifier = UUID:49d3b79e-b436-a242-93ba-b706b4364ab2; type = document; timestamp = 2024-08-29 12:34:56+0000</a></td></tr></table></blockquote><h3>Properties</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td><td><b>Value[x]</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:">Product Part Identifier</span></td><td><span title="Codes:">Purple Layer</span></td></tr></table></blockquote><blockquote><p><b>component</b></p><p><b>type</b>: <span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C66831}">Layer</span></p><p><b>amount</b>: 1476.03 gram<span style="background: LightGoldenRodYellow"> (Details: UCUM codeg = 'g')</span>, 61.45 percent<span style="background: LightGoldenRodYellow"> (Details: UCUM code% = '%')</span></p><blockquote><p><b>constituent</b></p><p><b>amount</b>: 600.01 gram<span style="background: LightGoldenRodYellow"> (Details: UCUM codeg = 'g')</span>, 40.65 percent<span style="background: LightGoldenRodYellow"> (Details: UCUM code% = '%')</span></p><p><b>location</b>: <span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C203881}">Example1Drug_LayerB</span></p><h3>HasIngredients</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-49d3b79e-b436-a242-93ba-b706b4364ab2.html#urn-uuid-fbd464cc-2511-4a3a-b058-3cec4fffd14f">Bundle: identifier = UUID:49d3b79e-b436-a242-93ba-b706b4364ab2; type = document; timestamp = 2024-08-29 12:34:56+0000</a></td></tr></table></blockquote><blockquote><p><b>constituent</b></p><p><b>amount</b>: 876.02 gram<span style="background: LightGoldenRodYellow"> (Details: UCUM codeg = 'g')</span>, 59.35 percent<span style="background: LightGoldenRodYellow"> (Details: UCUM code% = '%')</span></p><p><b>location</b>: <span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C203883}">Example1Drug_LayerB</span></p><h3>HasIngredients</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-49d3b79e-b436-a242-93ba-b706b4364ab2.html#urn-uuid-9973ba9a-b257-425a-8fb9-6dcfe379ca08">Bundle: identifier = UUID:49d3b79e-b436-a242-93ba-b706b4364ab2; type = document; timestamp = 2024-08-29 12:34:56+0000</a></td></tr></table></blockquote><blockquote><p><b>constituent</b></p><p><b>amount</b>: 369.01 gram<span style="background: LightGoldenRodYellow"> (Details: UCUM codeg = 'g')</span>, 25 percent<span style="background: LightGoldenRodYellow"> (Details: UCUM code% = '%')</span></p><p><b>location</b>: <span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C203882}">Example1Drug_LayerB</span></p><h3>HasIngredients</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-49d3b79e-b436-a242-93ba-b706b4364ab2.html#urn-uuid-95648837-ec81-42d9-970c-eac390f2f604">Bundle: identifier = UUID:49d3b79e-b436-a242-93ba-b706b4364ab2; type = document; timestamp = 2024-08-29 12:34:56+0000</a></td></tr></table></blockquote><h3>Properties</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td><td><b>Value[x]</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:">Product Part Identifier</span></td><td><span title="Codes:">Example1Drug_LayerB</span></td></tr></table></blockquote></div>
</text>
<identifier>
<value value="ASPIRIN-ACETAMINOPHEN"/>
</identifier>
<status value="active"/>
<name value="ASPIRIN 200mg, ACETAMINOPHEN 300mg 2000 tablets"/>
<manufacturedDoseForm>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C154605"/>
<display value="Tablet"/>
</coding>
</manufacturedDoseForm>
<manufacturer>
<reference value="urn:uuid:b69435a0-45c6-4d44-9fde-b354e17408d7"/>
</manufacturer>
<property>
<type>
<text value="Batch Quantity"/>
</type>
<valueQuantity>
<value value="2000"/>
<unit value="1*"/>
<system value="http://unitsofmeasure.org"/>
<code value="1"/>
</valueQuantity>
</property>
<property>
<type>
<text value="Batch Utilization"/>
</type>
<valueCodeableConcept>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C133991"/>
<display value="Development"/>
</coding>
</valueCodeableConcept>
</property>
<property>
<type>
<text value="Product Part Additional Information"/>
</type>
<valueMarkdown
value="Makes 2000 tablets equivalent to 2.402 kilograms, accounting for losses from evaporation"/>
</property>
<component>
<type>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C66831"/>
<display value="Layer"/>
</coding>
</type>
<amount>
<value value="925.97"/>
<unit value="gram"/>
<system value="http://unitsofmeasure.org"/>
<code value="g"/>
</amount>
<amount>
<value value="38.55"/>
<unit value="percent"/>
<system value="http://unitsofmeasure.org"/>
<code value="%"/>
</amount>
<constituent>
<amount>
<value value="400"/>
<unit value="gram"/>
<system value="http://unitsofmeasure.org"/>
<code value="g"/>
</amount>
<amount>
<value value="43.1"/>
<unit value="percent"/>
<system value="http://unitsofmeasure.org"/>
<code value="%"/>
</amount>
<location>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C203881"/>
<display value="Active core/granulate"/>
</coding>
<text value="Purple Layer"/>
</location>
<hasIngredient>
<reference>
<reference
value="urn:uuid:d4713a90-38d1-49e5-a977-78c63e518562"/>
</reference>
</hasIngredient>
</constituent>
<constituent>
<amount>
<value value="524.01"/>
<unit value="gram"/>
<system value="http://unitsofmeasure.org"/>
<code value="g"/>
</amount>
<amount>
<value value="56.59"/>
<unit value="percent"/>
<system value="http://unitsofmeasure.org"/>
<code value="%"/>
</amount>
<location>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C203883"/>
<display value="Intragranular"/>
</coding>
<text value="Purple Layer"/>
</location>
<hasIngredient>
<reference>
<reference
value="urn:uuid:9973ba9a-b257-425a-8fb9-6dcfe379ca08"/>
</reference>
</hasIngredient>
</constituent>
<constituent>
<amount>
<value value="203.71"/>
<unit value="gram"/>
<system value="http://unitsofmeasure.org"/>
<code value="g"/>
</amount>
<amount>
<value value="22"/>
<unit value="percent"/>
<system value="http://unitsofmeasure.org"/>
<code value="%"/>
</amount>
<location>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C203882"/>
<display value="Extragranular"/>
</coding>
<text value="Purple Layer"/>
</location>
<hasIngredient>
<reference>
<reference
value="urn:uuid:4e394a0c-4b25-492e-aac7-0faf121ffc4f"/>
</reference>
</hasIngredient>
</constituent>
<constituent>
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-product-batch-ingredient-extension">
<extension url="overagePercent">
<valueDecimal value="0.02"/>
</extension>
<extension url="overageJustification">
<valueMarkdown value="Evaporation"/>
</extension>
</extension>
<amount>
<value value="311.68"/>
<unit value="gram"/>
<system value="http://unitsofmeasure.org"/>
<code value="g"/>
</amount>
<amount>
<value value="33"/>
<unit value="percent"/>
<system value="http://unitsofmeasure.org"/>
<code value="%"/>
</amount>
<location>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C203882"/>
<display value="Extragranular"/>
</coding>
<text value="Purple Layer"/>
</location>
<hasIngredient>
<reference>
<reference
value="urn:uuid:95648837-ec81-42d9-970c-eac390f2f604"/>
</reference>
</hasIngredient>
</constituent>
<property>
<type>
<text value="Product Part Identifier"/>
</type>
<valueCodeableConcept>
<text value="Purple Layer"/>
</valueCodeableConcept>
</property>
</component>
<component>
<type>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C66831"/>
<display value="Layer"/>
</coding>
</type>
<amount>
<value value="1476.03"/>
<unit value="gram"/>
<system value="http://unitsofmeasure.org"/>
<code value="g"/>
</amount>
<amount>
<value value="61.45"/>
<unit value="percent"/>
<system value="http://unitsofmeasure.org"/>
<code value="%"/>
</amount>
<constituent>
<amount>
<value value="600.01"/>
<unit value="gram"/>
<system value="http://unitsofmeasure.org"/>
<code value="g"/>
</amount>
<amount>
<value value="40.65"/>
<unit value="percent"/>
<system value="http://unitsofmeasure.org"/>
<code value="%"/>
</amount>
<location>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C203881"/>
<display value="Active core/granulate"/>
</coding>
<text value="Example1Drug_LayerB"/>
</location>
<hasIngredient>
<reference>
<reference
value="urn:uuid:fbd464cc-2511-4a3a-b058-3cec4fffd14f"/>
</reference>
</hasIngredient>
</constituent>
<constituent>
<amount>
<value value="876.02"/>
<unit value="gram"/>
<system value="http://unitsofmeasure.org"/>
<code value="g"/>
</amount>
<amount>
<value value="59.35"/>
<unit value="percent"/>
<system value="http://unitsofmeasure.org"/>
<code value="%"/>
</amount>
<location>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C203883"/>
<display value="Intragranular"/>
</coding>
<text value="Example1Drug_LayerB"/>
</location>
<hasIngredient>
<reference>
<reference
value="urn:uuid:9973ba9a-b257-425a-8fb9-6dcfe379ca08"/>
</reference>
</hasIngredient>
</constituent>
<constituent>
<amount>
<value value="369.01"/>
<unit value="gram"/>
<system value="http://unitsofmeasure.org"/>
<code value="g"/>
</amount>
<amount>
<value value="25"/>
<unit value="percent"/>
<system value="http://unitsofmeasure.org"/>
<code value="%"/>
</amount>
<location>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C203882"/>
<display value="Extragranular"/>
</coding>
<text value="Example1Drug_LayerB"/>
</location>
<hasIngredient>
<reference>
<reference
value="urn:uuid:95648837-ec81-42d9-970c-eac390f2f604"/>
</reference>
</hasIngredient>
</constituent>
<property>
<type>
<text value="Product Part Identifier"/>
</type>
<valueCodeableConcept>
<text value="Example1Drug_LayerB"/>
</valueCodeableConcept>
</property>
</component>
</ManufacturedItemDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:d4713a90-38d1-49e5-a977-78c63e518562"/>
<resource>
<Ingredient>
<id value="d4713a90-38d1-49e5-a977-78c63e518562"/>
<meta>
<profile
value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-dp-ingredient"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Ingredient_d4713a90-38d1-49e5-a977-78c63e518562"> </a><p class="res-header-id"><b>Generated Narrative: Ingredient d4713a90-38d1-49e5-a977-78c63e518562</b></p><a name="d4713a90-38d1-49e5-a977-78c63e518562"> </a><a name="hcd4713a90-38d1-49e5-a977-78c63e518562"> </a><a name="d4713a90-38d1-49e5-a977-78c63e518562-en-US"> </a><p><b>identifier</b>: Asprin - Ingredient</p><p><b>status</b>: Active</p><p><b>role</b>: <span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C82533}">Active Ingredient</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-49d3b79e-b436-a242-93ba-b706b4364ab2.html#urn-uuid-cbb54715-3928-4e3f-9abe-32914f694957">Bundle: identifier = UUID:49d3b79e-b436-a242-93ba-b706b4364ab2; type = document; timestamp = 2024-08-29 12:34:56+0000</a></td></tr></table><blockquote><p><b>strength</b></p><p><b>concentration</b>: 400 gram<span style="background: LightGoldenRodYellow"> (Details: UCUM codeg = 'g')</span></p></blockquote><blockquote><p><b>strength</b></p><p><b>concentration</b>: 10.4 percent<span style="background: LightGoldenRodYellow"> (Details: UCUM code% = '%')</span></p></blockquote></blockquote></div>
</text>
<identifier>
<value value="Asprin - Ingredient"/>
</identifier>
<status value="active"/>
<role>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C82533"/>
<display value="Active Ingredient"/>
</coding>
</role>
<substance>
<code>
<reference>
<reference
value="urn:uuid:cbb54715-3928-4e3f-9abe-32914f694957"/>
</reference>
</code>
<strength>
<concentrationQuantity>
<value value="400"/>
<unit value="gram"/>
<system value="http://unitsofmeasure.org"/>
<code value="g"/>
</concentrationQuantity>
</strength>
<strength>
<concentrationQuantity>
<value value="10.4"/>
<unit value="percent"/>
<system value="http://unitsofmeasure.org"/>
<code value="%"/>
</concentrationQuantity>
</strength>
</substance>
</Ingredient>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:fbd464cc-2511-4a3a-b058-3cec4fffd14f"/>
<resource>
<Ingredient>
<id value="fbd464cc-2511-4a3a-b058-3cec4fffd14f"/>
<meta>
<profile
value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-dp-ingredient"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Ingredient_fbd464cc-2511-4a3a-b058-3cec4fffd14f"> </a><p class="res-header-id"><b>Generated Narrative: Ingredient fbd464cc-2511-4a3a-b058-3cec4fffd14f</b></p><a name="fbd464cc-2511-4a3a-b058-3cec4fffd14f"> </a><a name="hcfbd464cc-2511-4a3a-b058-3cec4fffd14f"> </a><a name="fbd464cc-2511-4a3a-b058-3cec4fffd14f-en-US"> </a><p><b>identifier</b>: AcetaminophenIngredient</p><p><b>status</b>: Active</p><p><b>role</b>: <span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C82533}">Active Ingredient</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-49d3b79e-b436-a242-93ba-b706b4364ab2.html#urn-uuid-ca1ff85f-3f05-46be-8cc4-30b076d88c13">Bundle: identifier = UUID:49d3b79e-b436-a242-93ba-b706b4364ab2; type = document; timestamp = 2024-08-29 12:34:56+0000</a></td></tr></table><blockquote><p><b>strength</b></p><p><b>concentration</b>: 600 gram<span style="background: LightGoldenRodYellow"> (Details: UCUM codeg = 'g')</span></p></blockquote><blockquote><p><b>strength</b></p><p><b>concentration</b>: 25 percent<span style="background: LightGoldenRodYellow"> (Details: UCUM code% = '%')</span></p></blockquote></blockquote></div>
</text>
<identifier>
<value value="AcetaminophenIngredient"/>
</identifier>
<status value="active"/>
<role>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C82533"/>
<display value="Active Ingredient"/>
</coding>
</role>
<substance>
<code>
<reference>
<reference
value="urn:uuid:ca1ff85f-3f05-46be-8cc4-30b076d88c13"/>
</reference>
</code>
<strength>
<concentrationQuantity>
<value value="600"/>
<unit value="gram"/>
<system value="http://unitsofmeasure.org"/>
<code value="g"/>
</concentrationQuantity>
</strength>
<strength>
<concentrationQuantity>
<value value="25"/>
<unit value="percent"/>
<system value="http://unitsofmeasure.org"/>
<code value="%"/>
</concentrationQuantity>
</strength>
</substance>
</Ingredient>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:9973ba9a-b257-425a-8fb9-6dcfe379ca08"/>
<resource>
<Ingredient>
<id value="9973ba9a-b257-425a-8fb9-6dcfe379ca08"/>
<meta>
<profile
value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-dp-ingredient"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Ingredient_9973ba9a-b257-425a-8fb9-6dcfe379ca08"> </a><p class="res-header-id"><b>Generated Narrative: Ingredient 9973ba9a-b257-425a-8fb9-6dcfe379ca08</b></p><a name="9973ba9a-b257-425a-8fb9-6dcfe379ca08"> </a><a name="hc9973ba9a-b257-425a-8fb9-6dcfe379ca08"> </a><a name="9973ba9a-b257-425a-8fb9-6dcfe379ca08-en-US"> </a><p><b>identifier</b>: MaizeStarchIngredient</p><p><b>status</b>: Active</p><p><b>role</b>: <span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C42637}">Inactive Ingredient</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-49d3b79e-b436-a242-93ba-b706b4364ab2.html#urn-uuid-99f4a24f-880f-45f1-8364-8e4e03977b2e">Bundle: identifier = UUID:49d3b79e-b436-a242-93ba-b706b4364ab2; type = document; timestamp = 2024-08-29 12:34:56+0000</a></td></tr></table><blockquote><p><b>strength</b></p><p><b>concentration</b>: 1400.03 gram<span style="background: LightGoldenRodYellow"> (Details: UCUM codeg = 'g')</span></p></blockquote><blockquote><p><b>strength</b></p><p><b>concentration</b>: 58.28 percent<span style="background: LightGoldenRodYellow"> (Details: UCUM code% = '%')</span></p></blockquote></blockquote></div>
</text>
<identifier>
<value value="MaizeStarchIngredient"/>
</identifier>
<status value="active"/>
<role>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C42637"/>
<display value="Inactive Ingredient"/>
</coding>
</role>
<substance>
<code>
<reference>
<reference
value="urn:uuid:99f4a24f-880f-45f1-8364-8e4e03977b2e"/>
</reference>
</code>
<strength>
<concentrationQuantity>
<value value="1400.03"/>
<unit value="gram"/>
<system value="http://unitsofmeasure.org"/>
<code value="g"/>
</concentrationQuantity>
</strength>
<strength>
<concentrationQuantity>
<value value="58.28"/>
<unit value="percent"/>
<system value="http://unitsofmeasure.org"/>
<code value="%"/>
</concentrationQuantity>
</strength>
</substance>
</Ingredient>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:4e394a0c-4b25-492e-aac7-0faf121ffc4f"/>
<resource>
<Ingredient>
<id value="4e394a0c-4b25-492e-aac7-0faf121ffc4f"/>
<meta>
<profile
value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-dp-ingredient"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Ingredient_4e394a0c-4b25-492e-aac7-0faf121ffc4f"> </a><p class="res-header-id"><b>Generated Narrative: Ingredient 4e394a0c-4b25-492e-aac7-0faf121ffc4f</b></p><a name="4e394a0c-4b25-492e-aac7-0faf121ffc4f"> </a><a name="hc4e394a0c-4b25-492e-aac7-0faf121ffc4f"> </a><a name="4e394a0c-4b25-492e-aac7-0faf121ffc4f-en-US"> </a><p><b>identifier</b>: GrapeskinIngredient</p><p><b>status</b>: Active</p><p><b>role</b>: <span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C42637}">Inactive Ingredient</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-49d3b79e-b436-a242-93ba-b706b4364ab2.html#urn-uuid-a4624559-6c4f-4e90-996d-bc3bf2f5a3f4">Bundle: identifier = UUID:49d3b79e-b436-a242-93ba-b706b4364ab2; type = document; timestamp = 2024-08-29 12:34:56+0000</a></td></tr></table><blockquote><p><b>strength</b></p><p><b>concentration</b>: 203.71 gram<span style="background: LightGoldenRodYellow"> (Details: UCUM codeg = 'g')</span></p></blockquote><blockquote><p><b>strength</b></p><p><b>concentration</b>: 8.48 percent<span style="background: LightGoldenRodYellow"> (Details: UCUM code% = '%')</span></p></blockquote></blockquote></div>
</text>
<identifier>
<value value="GrapeskinIngredient"/>
</identifier>
<status value="active"/>
<role>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C42637"/>
<display value="Inactive Ingredient"/>
</coding>
</role>
<substance>
<code>
<reference>
<reference
value="urn:uuid:a4624559-6c4f-4e90-996d-bc3bf2f5a3f4"/>
</reference>
</code>
<strength>
<concentrationQuantity>
<value value="203.71"/>
<unit value="gram"/>
<system value="http://unitsofmeasure.org"/>
<code value="g"/>
</concentrationQuantity>
</strength>
<strength>
<concentrationQuantity>
<value value="8.48"/>
<unit value="percent"/>
<system value="http://unitsofmeasure.org"/>
<code value="%"/>
</concentrationQuantity>
</strength>
</substance>
</Ingredient>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:95648837-ec81-42d9-970c-eac390f2f604"/>
<resource>
<Ingredient>
<id value="95648837-ec81-42d9-970c-eac390f2f604"/>
<meta>
<profile
value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-dp-ingredient"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Ingredient_95648837-ec81-42d9-970c-eac390f2f604"> </a><p class="res-header-id"><b>Generated Narrative: Ingredient 95648837-ec81-42d9-970c-eac390f2f604</b></p><a name="95648837-ec81-42d9-970c-eac390f2f604"> </a><a name="hc95648837-ec81-42d9-970c-eac390f2f604"> </a><a name="95648837-ec81-42d9-970c-eac390f2f604-en-US"> </a><p><b>identifier</b>: WaterBFIngredient</p><p><b>status</b>: Active</p><p><b>role</b>: <span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C42637}">Inactive Ingredient</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-49d3b79e-b436-a242-93ba-b706b4364ab2.html#urn-uuid-254742fb-7b5b-49f5-b4af-e0d14d81f2f6">Bundle: identifier = UUID:49d3b79e-b436-a242-93ba-b706b4364ab2; type = document; timestamp = 2024-08-29 12:34:56+0000</a></td></tr></table><blockquote><p><b>strength</b></p><p><b>concentration</b>: 50.75 kilogram<span style="background: LightGoldenRodYellow"> (Details: UCUM codekg = 'kg')</span></p></blockquote><blockquote><p><b>strength</b></p><p><b>concentration</b>: 95.3572 percent<span style="background: LightGoldenRodYellow"> (Details: UCUM code% = '%')</span></p></blockquote></blockquote></div>
</text>
<identifier>
<value value="WaterBFIngredient"/>
</identifier>
<status value="active"/>
<role>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C42637"/>
<display value="Inactive Ingredient"/>
</coding>
</role>
<substance>
<code>
<reference>
<reference
value="urn:uuid:254742fb-7b5b-49f5-b4af-e0d14d81f2f6"/>
</reference>
</code>
<strength>
<concentrationQuantity>
<value value="50.75"/>
<unit value="kilogram"/>
<system value="http://unitsofmeasure.org"/>
<code value="kg"/>
</concentrationQuantity>
</strength>
<strength>
<concentrationQuantity>
<value value="95.3572"/>
<unit value="percent"/>
<system value="http://unitsofmeasure.org"/>
<code value="%"/>
</concentrationQuantity>
</strength>
</substance>
</Ingredient>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:cbb54715-3928-4e3f-9abe-32914f694957"/>
<resource>
<SubstanceDefinition>
<id value="cbb54715-3928-4e3f-9abe-32914f694957"/>
<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"><a name="SubstanceDefinition_cbb54715-3928-4e3f-9abe-32914f694957"> </a><p class="res-header-id"><b>Generated Narrative: SubstanceDefinition cbb54715-3928-4e3f-9abe-32914f694957</b></p><a name="cbb54715-3928-4e3f-9abe-32914f694957"> </a><a name="hccbb54715-3928-4e3f-9abe-32914f694957"> </a><a name="cbb54715-3928-4e3f-9abe-32914f694957-en-US"> </a><p><b>classification</b>: <span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C48807}">Chemical</span></p><p><b>grade</b>: <span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C134006}">USP-NF</span></p><p><b>manufacturer</b>: <a href="Bundle-30536c0e-456c-4f90-9f02-da7be1d289e9.html#urn-uuid-e165f057-5eed-4e64-8328-4438fc88fb1b">Bundle: identifier = UUID:1bf43677-1c61-41dd-93c2-8ec7f327d0f1; type = document; timestamp = 2023-12-15 22:19:47+0000</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><span title="Codes:{http://fdasis.nlm.nih.gov R16CO5Y76E}">R16CO5Y76E</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>ASPIRIN</td><td><span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C203355}">GSRS Preferred Term</span></td><td>true</td></tr></table></div>
</text>
<classification>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C48807"/>
<display value="Chemical"/>
</coding>
</classification>
<grade>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C134006"/>
<display value="USP-NF"/>
</coding>
</grade>
<manufacturer>
<reference value="urn:uuid:e165f057-5eed-4e64-8328-4438fc88fb1b"/>
</manufacturer>
<code>
<code>
<coding>
<system value="http://fdasis.nlm.nih.gov"/>
<code value="R16CO5Y76E"/>
</coding>
</code>
</code>
<name>
<name value="ASPIRIN"/>
<type>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C203355"/>
<display value="GSRS Preferred Term"/>
</coding>
</type>
<preferred value="true"/>
</name>
</SubstanceDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:ca1ff85f-3f05-46be-8cc4-30b076d88c13"/>
<resource>
<SubstanceDefinition>
<id value="ca1ff85f-3f05-46be-8cc4-30b076d88c13"/>
<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"><a name="SubstanceDefinition_ca1ff85f-3f05-46be-8cc4-30b076d88c13"> </a><p class="res-header-id"><b>Generated Narrative: SubstanceDefinition ca1ff85f-3f05-46be-8cc4-30b076d88c13</b></p><a name="ca1ff85f-3f05-46be-8cc4-30b076d88c13"> </a><a name="hcca1ff85f-3f05-46be-8cc4-30b076d88c13"> </a><a name="ca1ff85f-3f05-46be-8cc4-30b076d88c13-en-US"> </a><p><b>classification</b>: <span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C48807}">Chemical</span></p><p><b>grade</b>: <span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C134006}">USP-NF</span></p><p><b>manufacturer</b>: <a href="Bundle-49d3b79e-b436-a242-93ba-b706b4364ab2.html#urn-uuid-4b565cf3-5353-48af-8cd6-5ccf4e9fd579">Bundle: identifier = UUID:49d3b79e-b436-a242-93ba-b706b4364ab2; type = document; timestamp = 2024-08-29 12:34:56+0000</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><span title="Codes:{http://fdasis.nlm.nih.gov 362O9ITL9D}">362O9ITL9D</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>ACETAMINOPHEN</td><td><span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C203355}">GSRS Preferred Term</span></td><td>true</td></tr></table></div>
</text>
<classification>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C48807"/>
<display value="Chemical"/>
</coding>
</classification>
<grade>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C134006"/>
<display value="USP-NF"/>
</coding>
</grade>
<manufacturer>
<reference value="urn:uuid:4b565cf3-5353-48af-8cd6-5ccf4e9fd579"/>
</manufacturer>
<code>
<code>
<coding>
<system value="http://fdasis.nlm.nih.gov"/>
<code value="362O9ITL9D"/>
</coding>
</code>
</code>
<name>
<name value="ACETAMINOPHEN"/>
<type>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C203355"/>
<display value="GSRS Preferred Term"/>
</coding>
</type>
<preferred value="true"/>
</name>
</SubstanceDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:99f4a24f-880f-45f1-8364-8e4e03977b2e"/>
<resource>
<SubstanceDefinition>
<id value="99f4a24f-880f-45f1-8364-8e4e03977b2e"/>
<meta>
<profile
value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-excipient"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="SubstanceDefinition_99f4a24f-880f-45f1-8364-8e4e03977b2e"> </a><p class="res-header-id"><b>Generated Narrative: SubstanceDefinition 99f4a24f-880f-45f1-8364-8e4e03977b2e</b></p><a name="99f4a24f-880f-45f1-8364-8e4e03977b2e"> </a><a name="hc99f4a24f-880f-45f1-8364-8e4e03977b2e"> </a><a name="99f4a24f-880f-45f1-8364-8e4e03977b2e-en-US"> </a><p><b>classification</b>: <span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C45305}">Mixture</span></p><p><b>grade</b>: <span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C134009}">Company Standard</span></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><span title="Codes:{http://fdasis.nlm.nih.gov O8232NY3SJ}">O8232NY3SJ</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>STARCH, CORN</td><td><span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C203355}">GSRS Preferred Term</span></td><td>true</td></tr></table><h3>SourceMaterials</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C48807}">Chemical</span></td></tr></table></div>
</text>
<classification>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C45305"/>
<display value="Mixture"/>
</coding>
</classification>
<grade>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C134009"/>
<display value="Company Standard"/>
</coding>
</grade>
<code>
<code>
<coding>
<system value="http://fdasis.nlm.nih.gov"/>
<code value="O8232NY3SJ"/>
</coding>
</code>
</code>
<name>
<name value="STARCH, CORN"/>
<type>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C203355"/>
<display value="GSRS Preferred Term"/>
</coding>
</type>
<preferred value="true"/>
</name>
<sourceMaterial>
<type>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C48807"/>
<display value="Chemical"/>
</coding>
</type>
</sourceMaterial>
</SubstanceDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:a4624559-6c4f-4e90-996d-bc3bf2f5a3f4"/>
<resource>
<SubstanceDefinition>
<id value="a4624559-6c4f-4e90-996d-bc3bf2f5a3f4"/>
<meta>
<profile
value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-excipient"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="SubstanceDefinition_a4624559-6c4f-4e90-996d-bc3bf2f5a3f4"> </a><p class="res-header-id"><b>Generated Narrative: SubstanceDefinition a4624559-6c4f-4e90-996d-bc3bf2f5a3f4</b></p><a name="a4624559-6c4f-4e90-996d-bc3bf2f5a3f4"> </a><a name="hca4624559-6c4f-4e90-996d-bc3bf2f5a3f4"> </a><a name="a4624559-6c4f-4e90-996d-bc3bf2f5a3f4-en-US"> </a><p><b>classification</b>: <span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C45305}">Mixture</span></p><p><b>grade</b>: <span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C176793}">BP</span></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><span title="Codes:{http://fdasis.nlm.nih.gov 3GOV20705G}">3GOV20705G</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>WINE GRAPE</td><td><span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C203355}">GSRS Preferred Term</span></td><td>true</td></tr></table><h3>SourceMaterials</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C14258}">Plant</span></td></tr></table></div>
</text>
<classification>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C45305"/>
<display value="Mixture"/>
</coding>
</classification>
<grade>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C176793"/>
<display value="BP"/>
</coding>
</grade>
<code>
<code>
<coding>
<system value="http://fdasis.nlm.nih.gov"/>
<code value="3GOV20705G"/>
</coding>
</code>
</code>
<name>
<name value="WINE GRAPE"/>
<type>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C203355"/>
<display value="GSRS Preferred Term"/>
</coding>
</type>
<preferred value="true"/>
</name>
<sourceMaterial>
<type>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C14258"/>
<display value="Plant"/>
</coding>
</type>
</sourceMaterial>
</SubstanceDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:254742fb-7b5b-49f5-b4af-e0d14d81f2f6"/>
<resource>
<SubstanceDefinition>
<id value="254742fb-7b5b-49f5-b4af-e0d14d81f2f6"/>
<meta>
<profile
value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-excipient"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="SubstanceDefinition_254742fb-7b5b-49f5-b4af-e0d14d81f2f6"> </a><p class="res-header-id"><b>Generated Narrative: SubstanceDefinition 254742fb-7b5b-49f5-b4af-e0d14d81f2f6</b></p><a name="254742fb-7b5b-49f5-b4af-e0d14d81f2f6"> </a><a name="hc254742fb-7b5b-49f5-b4af-e0d14d81f2f6"> </a><a name="254742fb-7b5b-49f5-b4af-e0d14d81f2f6-en-US"> </a><p><b>classification</b>: <span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C48807}">Chemical</span></p><p><b>grade</b>: <span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C134006}">USP-NF</span></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><span title="Codes:{http://fdasis.nlm.nih.gov 059QF0KO0R}">059QF0KO0R</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>WATER</td><td><span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C203355}">GSRS Preferred Term</span></td><td>true</td></tr></table><h3>SourceMaterials</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C48807}">Chemical</span></td></tr></table></div>
</text>
<classification>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C48807"/>
<display value="Chemical"/>
</coding>
</classification>
<grade>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C134006"/>
<display value="USP-NF"/>
</coding>
</grade>
<code>
<code>
<coding>
<system value="http://fdasis.nlm.nih.gov"/>
<code value="059QF0KO0R"/>
</coding>
</code>
</code>
<name>
<name value="WATER"/>
<type>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C203355"/>
<display value="GSRS Preferred Term"/>
</coding>
</type>
<preferred value="true"/>
</name>
<sourceMaterial>
<type>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C48807"/>
<display value="Chemical"/>
</coding>
</type>
</sourceMaterial>
</SubstanceDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:4b565cf3-5353-48af-8cd6-5ccf4e9fd579"/>
<resource>
<Organization>
<id value="4b565cf3-5353-48af-8cd6-5ccf4e9fd579"/>
<meta>
<profile
value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-organization"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Organization_4b565cf3-5353-48af-8cd6-5ccf4e9fd579"> </a><p class="res-header-id"><b>Generated Narrative: Organization 4b565cf3-5353-48af-8cd6-5ccf4e9fd579</b></p><a name="4b565cf3-5353-48af-8cd6-5ccf4e9fd579"> </a><a name="hc4b565cf3-5353-48af-8cd6-5ccf4e9fd579"> </a><a name="4b565cf3-5353-48af-8cd6-5ccf4e9fd579-en-US"> </a><p><b>identifier</b>: DUNS/783452221, FEI/6913973</p><p><b>name</b>: Manufacturing Site (J. Jones Research)</p><h3>Contacts</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Address</b></td></tr><tr><td style="display: none">*</td><td>Manufacturing Site (J. Jones Research), 444 Grant Street, Bedford, NY, United States</td></tr></table></div>
</text>
<identifier>
<type>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C134003"/>
<display value="DUNS"/>
</coding>
</type>
<system value="urn:oid:1.3.6.1.4.1.519.1"/>
<value value="783452221"/>
</identifier>
<identifier>
<type>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C134004"/>
<display value="FEI"/>
</coding>
</type>
<system value="urn:oid:2.16.840.1.113883.4.82"/>
<value value="6913973"/>
</identifier>
<name value="Manufacturing Site (J. Jones Research)"/>
<contact>
<address>
<type value="postal"/>
<text
value="Manufacturing Site (J. Jones Research), 444 Grant Street, Bedford, NY, United States"/>
<line value="444 Grant Street"/>
<city value="Bedford"/>
<state value="NY"/>
<postalCode value="15600"/>
<country value="USA"/>
</address>
</contact>
</Organization>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:e165f057-5eed-4e64-8328-4438fc88fb1b"/>
<resource>
<Organization>
<id value="e165f057-5eed-4e64-8328-4438fc88fb1b"/>
<meta>
<profile
value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-organization"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Organization_e165f057-5eed-4e64-8328-4438fc88fb1b"> </a><p class="res-header-id"><b>Generated Narrative: Organization e165f057-5eed-4e64-8328-4438fc88fb1b</b></p><a name="e165f057-5eed-4e64-8328-4438fc88fb1b"> </a><a name="hce165f057-5eed-4e64-8328-4438fc88fb1b"> </a><a name="e165f057-5eed-4e64-8328-4438fc88fb1b-en-US"> </a><p><b>identifier</b>: DUNS/143265222</p><p><b>name</b>: Vandechemie</p><h3>Contacts</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Address</b></td></tr><tr><td style="display: none">*</td><td>Vandechemie, Ruzettelaan 39234, Blankenberge, 8370, Belgium</td></tr></table></div>
</text>
<identifier>
<type>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C134003"/>
<display value="DUNS"/>
</coding>
</type>
<system value="urn:oid:1.3.6.1.4.1.519.1"/>
<value value="143265222"/>
</identifier>
<name value="Vandechemie"/>
<contact>
<address>
<type value="postal"/>
<text
value="Vandechemie, Ruzettelaan 39234, Blankenberge, 8370, Belgium"/>
<line value="Ruzettelaan 39234"/>
<city value="Blankenberge"/>
<postalCode value="8370"/>
<country value="BEL"/>
</address>
</contact>
</Organization>
</resource>
</entry>
</Bundle>
IG © 2021+ HL7 International / Biomedical Research and Regulation. Package hl7.fhir.us.pq-cmc-fda#2.0.0-ballot based on FHIR 5.0.0. Generated 2024-12-04
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