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" : "<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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{
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"div" : "<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>\n</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>\n</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>"
},
"identifier" : [
{
"value" : "ASPIRIN-ACETAMINOPHEN"
}
],
"status" : "active",
"name" : "ASPIRIN 200mg, ACETAMINOPHEN 300mg 2000 tablets",
"manufacturedDoseForm" : {
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C154605",
"display" : "Tablet"
}
]
},
"manufacturer" : [
{
"reference" : "urn:uuid:b69435a0-45c6-4d44-9fde-b354e17408d7"
}
],
"property" : [
{
"type" : {
"text" : "Batch Quantity"
},
"valueQuantity" : {
"value" : 2000,
"unit" : "1*",
"system" : "http://unitsofmeasure.org",
"code" : "1"
}
},
{
"type" : {
"text" : "Batch Utilization"
},
"valueCodeableConcept" : {
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C133991",
"display" : "Development"
}
]
}
},
{
"type" : {
"text" : "Product Part Additional Information"
},
"valueMarkdown" : "Makes 2000 tablets equivalent to 2.402 kilograms, accounting for losses from evaporation"
}
],
"component" : [
{
"type" : {
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C66831",
"display" : "Layer"
}
]
},
"amount" : [
{
"value" : 925.97,
"unit" : "gram",
"system" : "http://unitsofmeasure.org",
"code" : "g"
},
{
"value" : 38.55,
"unit" : "percent",
"system" : "http://unitsofmeasure.org",
"code" : "%"
}
],
"constituent" : [
{
"amount" : [
{
"value" : 400,
"unit" : "gram",
"system" : "http://unitsofmeasure.org",
"code" : "g"
},
{
"value" : 43.1,
"unit" : "percent",
"system" : "http://unitsofmeasure.org",
"code" : "%"
}
],
"location" : [
{
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C203881",
"display" : "Active core/granulate"
}
],
"text" : "Purple Layer"
}
],
"hasIngredient" : [
{
"reference" : {
"reference" : "urn:uuid:d4713a90-38d1-49e5-a977-78c63e518562"
}
}
]
},
{
"amount" : [
{
"value" : 524.01,
"unit" : "gram",
"system" : "http://unitsofmeasure.org",
"code" : "g"
},
{
"value" : 56.59,
"unit" : "percent",
"system" : "http://unitsofmeasure.org",
"code" : "%"
}
],
"location" : [
{
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C203883",
"display" : "Intragranular"
}
],
"text" : "Purple Layer"
}
],
"hasIngredient" : [
{
"reference" : {
"reference" : "urn:uuid:9973ba9a-b257-425a-8fb9-6dcfe379ca08"
}
}
]
},
{
"amount" : [
{
"value" : 203.71,
"unit" : "gram",
"system" : "http://unitsofmeasure.org",
"code" : "g"
},
{
"value" : 22,
"unit" : "percent",
"system" : "http://unitsofmeasure.org",
"code" : "%"
}
],
"location" : [
{
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C203882",
"display" : "Extragranular"
}
],
"text" : "Purple Layer"
}
],
"hasIngredient" : [
{
"reference" : {
"reference" : "urn:uuid:4e394a0c-4b25-492e-aac7-0faf121ffc4f"
}
}
]
},
{
"extension" : [
{
"extension" : [
{
"url" : "overagePercent",
"valueDecimal" : 0.02
},
{
"url" : "overageJustification",
"valueMarkdown" : "Evaporation"
}
],
"url" : "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-product-batch-ingredient-extension"
}
],
"amount" : [
{
"value" : 311.68,
"unit" : "gram",
"system" : "http://unitsofmeasure.org",
"code" : "g"
},
{
"value" : 33,
"unit" : "percent",
"system" : "http://unitsofmeasure.org",
"code" : "%"
}
],
"location" : [
{
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C203882",
"display" : "Extragranular"
}
],
"text" : "Purple Layer"
}
],
"hasIngredient" : [
{
"reference" : {
"reference" : "urn:uuid:95648837-ec81-42d9-970c-eac390f2f604"
}
}
]
}
],
"property" : [
{
"type" : {
"text" : "Product Part Identifier"
},
"valueCodeableConcept" : {
"text" : "Purple Layer"
}
}
]
},
{
"type" : {
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C66831",
"display" : "Layer"
}
]
},
"amount" : [
{
"value" : 1476.03,
"unit" : "gram",
"system" : "http://unitsofmeasure.org",
"code" : "g"
},
{
"value" : 61.45,
"unit" : "percent",
"system" : "http://unitsofmeasure.org",
"code" : "%"
}
],
"constituent" : [
{
"amount" : [
{
"value" : 600.01,
"unit" : "gram",
"system" : "http://unitsofmeasure.org",
"code" : "g"
},
{
"value" : 40.65,
"unit" : "percent",
"system" : "http://unitsofmeasure.org",
"code" : "%"
}
],
"location" : [
{
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C203881",
"display" : "Active core/granulate"
}
],
"text" : "Example1Drug_LayerB"
}
],
"hasIngredient" : [
{
"reference" : {
"reference" : "urn:uuid:fbd464cc-2511-4a3a-b058-3cec4fffd14f"
}
}
]
},
{
"amount" : [
{
"value" : 876.02,
"unit" : "gram",
"system" : "http://unitsofmeasure.org",
"code" : "g"
},
{
"value" : 59.35,
"unit" : "percent",
"system" : "http://unitsofmeasure.org",
"code" : "%"
}
],
"location" : [
{
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C203883",
"display" : "Intragranular"
}
],
"text" : "Example1Drug_LayerB"
}
],
"hasIngredient" : [
{
"reference" : {
"reference" : "urn:uuid:9973ba9a-b257-425a-8fb9-6dcfe379ca08"
}
}
]
},
{
"amount" : [
{
"value" : 369.01,
"unit" : "gram",
"system" : "http://unitsofmeasure.org",
"code" : "g"
},
{
"value" : 25,
"unit" : "percent",
"system" : "http://unitsofmeasure.org",
"code" : "%"
}
],
"location" : [
{
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C203882",
"display" : "Extragranular"
}
],
"text" : "Example1Drug_LayerB"
}
],
"hasIngredient" : [
{
"reference" : {
"reference" : "urn:uuid:95648837-ec81-42d9-970c-eac390f2f604"
}
}
]
}
],
"property" : [
{
"type" : {
"text" : "Product Part Identifier"
},
"valueCodeableConcept" : {
"text" : "Example1Drug_LayerB"
}
}
]
}
]
}
},
{
"fullUrl" : "urn:uuid:d4713a90-38d1-49e5-a977-78c63e518562",
"resource" : {
"resourceType" : "Ingredient",
"id" : "d4713a90-38d1-49e5-a977-78c63e518562",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-dp-ingredient"
]
},
"text" : {
"status" : "generated",
"div" : "<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>"
},
"identifier" : {
"value" : "Asprin - Ingredient"
},
"status" : "active",
"role" : {
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C82533",
"display" : "Active Ingredient"
}
]
},
"substance" : {
"code" : {
"reference" : {
"reference" : "urn:uuid:cbb54715-3928-4e3f-9abe-32914f694957"
}
},
"strength" : [
{
"concentrationQuantity" : {
"value" : 400,
"unit" : "gram",
"system" : "http://unitsofmeasure.org",
"code" : "g"
}
},
{
"concentrationQuantity" : {
"value" : 10.4,
"unit" : "percent",
"system" : "http://unitsofmeasure.org",
"code" : "%"
}
}
]
}
}
},
{
"fullUrl" : "urn:uuid:fbd464cc-2511-4a3a-b058-3cec4fffd14f",
"resource" : {
"resourceType" : "Ingredient",
"id" : "fbd464cc-2511-4a3a-b058-3cec4fffd14f",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-dp-ingredient"
]
},
"text" : {
"status" : "generated",
"div" : "<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>"
},
"identifier" : {
"value" : "AcetaminophenIngredient"
},
"status" : "active",
"role" : {
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C82533",
"display" : "Active Ingredient"
}
]
},
"substance" : {
"code" : {
"reference" : {
"reference" : "urn:uuid:ca1ff85f-3f05-46be-8cc4-30b076d88c13"
}
},
"strength" : [
{
"concentrationQuantity" : {
"value" : 600,
"unit" : "gram",
"system" : "http://unitsofmeasure.org",
"code" : "g"
}
},
{
"concentrationQuantity" : {
"value" : 25,
"unit" : "percent",
"system" : "http://unitsofmeasure.org",
"code" : "%"
}
}
]
}
}
},
{
"fullUrl" : "urn:uuid:9973ba9a-b257-425a-8fb9-6dcfe379ca08",
"resource" : {
"resourceType" : "Ingredient",
"id" : "9973ba9a-b257-425a-8fb9-6dcfe379ca08",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-dp-ingredient"
]
},
"text" : {
"status" : "generated",
"div" : "<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>"
},
"identifier" : {
"value" : "MaizeStarchIngredient"
},
"status" : "active",
"role" : {
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C42637",
"display" : "Inactive Ingredient"
}
]
},
"substance" : {
"code" : {
"reference" : {
"reference" : "urn:uuid:99f4a24f-880f-45f1-8364-8e4e03977b2e"
}
},
"strength" : [
{
"concentrationQuantity" : {
"value" : 1400.03,
"unit" : "gram",
"system" : "http://unitsofmeasure.org",
"code" : "g"
}
},
{
"concentrationQuantity" : {
"value" : 58.28,
"unit" : "percent",
"system" : "http://unitsofmeasure.org",
"code" : "%"
}
}
]
}
}
},
{
"fullUrl" : "urn:uuid:4e394a0c-4b25-492e-aac7-0faf121ffc4f",
"resource" : {
"resourceType" : "Ingredient",
"id" : "4e394a0c-4b25-492e-aac7-0faf121ffc4f",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-dp-ingredient"
]
},
"text" : {
"status" : "generated",
"div" : "<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>"
},
"identifier" : {
"value" : "GrapeskinIngredient"
},
"status" : "active",
"role" : {
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C42637",
"display" : "Inactive Ingredient"
}
]
},
"substance" : {
"code" : {
"reference" : {
"reference" : "urn:uuid:a4624559-6c4f-4e90-996d-bc3bf2f5a3f4"
}
},
"strength" : [
{
"concentrationQuantity" : {
"value" : 203.71,
"unit" : "gram",
"system" : "http://unitsofmeasure.org",
"code" : "g"
}
},
{
"concentrationQuantity" : {
"value" : 8.48,
"unit" : "percent",
"system" : "http://unitsofmeasure.org",
"code" : "%"
}
}
]
}
}
},
{
"fullUrl" : "urn:uuid:95648837-ec81-42d9-970c-eac390f2f604",
"resource" : {
"resourceType" : "Ingredient",
"id" : "95648837-ec81-42d9-970c-eac390f2f604",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-dp-ingredient"
]
},
"text" : {
"status" : "generated",
"div" : "<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>"
},
"identifier" : {
"value" : "WaterBFIngredient"
},
"status" : "active",
"role" : {
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C42637",
"display" : "Inactive Ingredient"
}
]
},
"substance" : {
"code" : {
"reference" : {
"reference" : "urn:uuid:254742fb-7b5b-49f5-b4af-e0d14d81f2f6"
}
},
"strength" : [
{
"concentrationQuantity" : {
"value" : 50.75,
"unit" : "kilogram",
"system" : "http://unitsofmeasure.org",
"code" : "kg"
}
},
{
"concentrationQuantity" : {
"value" : 95.3572,
"unit" : "percent",
"system" : "http://unitsofmeasure.org",
"code" : "%"
}
}
]
}
}
},
{
"fullUrl" : "urn:uuid:cbb54715-3928-4e3f-9abe-32914f694957",
"resource" : {
"resourceType" : "SubstanceDefinition",
"id" : "cbb54715-3928-4e3f-9abe-32914f694957",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-routine-drug-substance"
]
},
"text" : {
"status" : "generated",
"div" : "<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>"
},
"classification" : [
{
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C48807",
"display" : "Chemical"
}
]
}
],
"grade" : [
{
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C134006",
"display" : "USP-NF"
}
]
}
],
"manufacturer" : [
{
"reference" : "urn:uuid:e165f057-5eed-4e64-8328-4438fc88fb1b"
}
],
"code" : [
{
"code" : {
"coding" : [
{
"system" : "http://fdasis.nlm.nih.gov",
"code" : "R16CO5Y76E"
}
]
}
}
],
"name" : [
{
"name" : "ASPIRIN",
"type" : {
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C203355",
"display" : "GSRS Preferred Term"
}
]
},
"preferred" : true
}
]
}
},
{
"fullUrl" : "urn:uuid:ca1ff85f-3f05-46be-8cc4-30b076d88c13",
"resource" : {
"resourceType" : "SubstanceDefinition",
"id" : "ca1ff85f-3f05-46be-8cc4-30b076d88c13",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-routine-drug-substance"
]
},
"text" : {
"status" : "generated",
"div" : "<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>"
},
"classification" : [
{
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C48807",
"display" : "Chemical"
}
]
}
],
"grade" : [
{
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C134006",
"display" : "USP-NF"
}
]
}
],
"manufacturer" : [
{
"reference" : "urn:uuid:4b565cf3-5353-48af-8cd6-5ccf4e9fd579"
}
],
"code" : [
{
"code" : {
"coding" : [
{
"system" : "http://fdasis.nlm.nih.gov",
"code" : "362O9ITL9D"
}
]
}
}
],
"name" : [
{
"name" : "ACETAMINOPHEN",
"type" : {
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C203355",
"display" : "GSRS Preferred Term"
}
]
},
"preferred" : true
}
]
}
},
{
"fullUrl" : "urn:uuid:99f4a24f-880f-45f1-8364-8e4e03977b2e",
"resource" : {
"resourceType" : "SubstanceDefinition",
"id" : "99f4a24f-880f-45f1-8364-8e4e03977b2e",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-excipient"
]
},
"text" : {
"status" : "generated",
"div" : "<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>"
},
"classification" : [
{
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C45305",
"display" : "Mixture"
}
]
}
],
"grade" : [
{
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C134009",
"display" : "Company Standard"
}
]
}
],
"code" : [
{
"code" : {
"coding" : [
{
"system" : "http://fdasis.nlm.nih.gov",
"code" : "O8232NY3SJ"
}
]
}
}
],
"name" : [
{
"name" : "STARCH, CORN",
"type" : {
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C203355",
"display" : "GSRS Preferred Term"
}
]
},
"preferred" : true
}
],
"sourceMaterial" : {
"type" : {
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C48807",
"display" : "Chemical"
}
]
}
}
}
},
{
"fullUrl" : "urn:uuid:a4624559-6c4f-4e90-996d-bc3bf2f5a3f4",
"resource" : {
"resourceType" : "SubstanceDefinition",
"id" : "a4624559-6c4f-4e90-996d-bc3bf2f5a3f4",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-excipient"
]
},
"text" : {
"status" : "generated",
"div" : "<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>"
},
"classification" : [
{
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C45305",
"display" : "Mixture"
}
]
}
],
"grade" : [
{
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C176793",
"display" : "BP"
}
]
}
],
"code" : [
{
"code" : {
"coding" : [
{
"system" : "http://fdasis.nlm.nih.gov",
"code" : "3GOV20705G"
}
]
}
}
],
"name" : [
{
"name" : "WINE GRAPE",
"type" : {
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C203355",
"display" : "GSRS Preferred Term"
}
]
},
"preferred" : true
}
],
"sourceMaterial" : {
"type" : {
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C14258",
"display" : "Plant"
}
]
}
}
}
},
{
"fullUrl" : "urn:uuid:254742fb-7b5b-49f5-b4af-e0d14d81f2f6",
"resource" : {
"resourceType" : "SubstanceDefinition",
"id" : "254742fb-7b5b-49f5-b4af-e0d14d81f2f6",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-excipient"
]
},
"text" : {
"status" : "generated",
"div" : "<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>"
},
"classification" : [
{
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C48807",
"display" : "Chemical"
}
]
}
],
"grade" : [
{
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C134006",
"display" : "USP-NF"
}
]
}
],
"code" : [
{
"code" : {
"coding" : [
{
"system" : "http://fdasis.nlm.nih.gov",
"code" : "059QF0KO0R"
}
]
}
}
],
"name" : [
{
"name" : "WATER",
"type" : {
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C203355",
"display" : "GSRS Preferred Term"
}
]
},
"preferred" : true
}
],
"sourceMaterial" : {
"type" : {
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C48807",
"display" : "Chemical"
}
]
}
}
}
},
{
"fullUrl" : "urn:uuid:4b565cf3-5353-48af-8cd6-5ccf4e9fd579",
"resource" : {
"resourceType" : "Organization",
"id" : "4b565cf3-5353-48af-8cd6-5ccf4e9fd579",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-organization"
]
},
"text" : {
"status" : "generated",
"div" : "<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>"
},
"identifier" : [
{
"type" : {
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C134003",
"display" : "DUNS"
}
]
},
"system" : "urn:oid:1.3.6.1.4.1.519.1",
"value" : "783452221"
},
{
"type" : {
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C134004",
"display" : "FEI"
}
]
},
"system" : "urn:oid:2.16.840.1.113883.4.82",
"value" : "6913973"
}
],
"name" : "Manufacturing Site (J. Jones Research)",
"contact" : [
{
"address" : {
"type" : "postal",
"text" : "Manufacturing Site (J. Jones Research), 444 Grant Street, Bedford, NY, United States",
"line" : [
"444 Grant Street"
],
"city" : "Bedford",
"state" : "NY",
"postalCode" : "15600",
"country" : "USA"
}
}
]
}
},
{
"fullUrl" : "urn:uuid:e165f057-5eed-4e64-8328-4438fc88fb1b",
"resource" : {
"resourceType" : "Organization",
"id" : "e165f057-5eed-4e64-8328-4438fc88fb1b",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-organization"
]
},
"text" : {
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"div" : "<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>"
},
"identifier" : [
{
"type" : {
"coding" : [
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}
]
},
"system" : "urn:oid:1.3.6.1.4.1.519.1",
"value" : "143265222"
}
],
"name" : "Vandechemie",
"contact" : [
{
"address" : {
"type" : "postal",
"text" : "Vandechemie, Ruzettelaan 39234, Blankenberge, 8370, Belgium",
"line" : [
"Ruzettelaan 39234"
],
"city" : "Blankenberge",
"postalCode" : "8370",
"country" : "BEL"
}
}
]
}
}
]
}
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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