Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 1.1.2 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/FHIR-us-pq-cmc-fda/ and changes regularly. See the Directory of published versions
{
"resourceType" : "MedicinalProductDefinition",
"id" : "ddd3abad-347c-4d2f-95f3-dd804e250502",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-drug-product-with-impurities"
]
},
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: MedicinalProductDefinition </b><a name=\"ddd3abad-347c-4d2f-95f3-dd804e250502\"> </a><a name=\"hcddd3abad-347c-4d2f-95f3-dd804e250502\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">ResourceMedicinalProductDefinition "ddd3abad-347c-4d2f-95f3-dd804e250502" </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-pqcmc-drug-product-with-impurities.html\">Drug Product Impurities</a></p></div><p><b>identifier</b>: TabletCoatedBeadsCoatedAll</p><p><b>description</b>: A drug product composed of one type of bead with two coatings inside a coated tablet</p><p><b>combinedPharmaceuticalDoseForm</b>: TABLET, MULTILAYER <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C42964)</span></p><h3>Impurities</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Reference</b></td></tr><tr><td style=\"display: none\">*</td><td><a href=\"Bundle-9e8f2d16-66b1-47ec-878d-f50ae021985b.html#urn-uuid-58ae52aa-c81e-415a-8791-e67a3195290d\">urn:uuid:58ae52aa-c81e-415a-8791-e67a3195290d</a></td></tr><tr><td style=\"display: none\">*</td><td><a href=\"Bundle-9e8f2d16-66b1-47ec-878d-f50ae021985b.html#urn-uuid-ffa30c0b-8031-436a-87f1-635b3bbe5989\">urn:uuid:ffa30c0b-8031-436a-87f1-635b3bbe5989</a></td></tr></table><blockquote><p><b>name</b></p><p><b>productName</b>: LEVOTHYROXINE SODIUM ANHYDROUS 125mg</p><p><b>type</b>: Non-Proprietary <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-product-name-types.html\">Product Name Types Code Types</a>#NON)</span></p><blockquote><p><b>part</b></p><p><b>part</b>: LEVOTHYROXINE SODIUM ANHYDROUS</p><p><b>type</b>: scientific name <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.5.0/CodeSystem-v3-EntityNamePartQualifierR2.html\">EntityNamePartQualifierR2</a>#SCI)</span></p></blockquote><blockquote><p><b>part</b></p><p><b>part</b>: 125mg</p><p><b>type</b>: LEVOTHYROXINE SODIUM ANHYDROUS <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.5.0/CodeSystem-v3-EntityNamePartQualifierR2.html\">EntityNamePartQualifierR2</a>#STR)</span></p></blockquote></blockquote></div>"
},
"identifier" : [
{
"value" : "TabletCoatedBeadsCoatedAll"
}
],
"description" : "A drug product composed of one type of bead with two coatings inside a coated tablet",
"combinedPharmaceuticalDoseForm" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
"code" : "C42964",
"display" : "TABLET, MULTILAYER"
}
]
},
"impurity" : [
{
"reference" : {
"reference" : "urn:uuid:58ae52aa-c81e-415a-8791-e67a3195290d"
}
},
{
"reference" : {
"reference" : "urn:uuid:ffa30c0b-8031-436a-87f1-635b3bbe5989"
}
}
],
"name" : [
{
"productName" : "LEVOTHYROXINE SODIUM ANHYDROUS 125mg",
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-product-name-types",
"code" : "NON",
"display" : "Non-Proprietary"
}
],
"text" : "Non-Proprietary"
},
"part" : [
{
"part" : "LEVOTHYROXINE SODIUM ANHYDROUS",
"type" : {
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2",
"code" : "SCI"
}
]
}
},
{
"part" : "125mg",
"type" : {
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2",
"code" : "STR"
}
],
"text" : "LEVOTHYROXINE SODIUM ANHYDROUS"
}
}
]
}
]
}