Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
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This page is part of the Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA (v1.0.0-ballot: STU1 Ballot 1) based on FHIR (HL7® FHIR® Standard) v5.0.0. . For a full list of available versions, see the Directory of published versions

: drug product for specification - JSON Representation

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{
  "resourceType" : "MedicinalProductDefinition",
  "id" : "89676a69-1fe7-422c-ab00-92abe4ef6ea9",
  "meta" : {
    "profile" : [
      🔗 "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-routine-drug-product"
    ]
  },
  "text" : {
    "status" : "generated",
    "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: MedicinalProductDefinition</b><a name=\"89676a69-1fe7-422c-ab00-92abe4ef6ea9\"> </a><a name=\"hc89676a69-1fe7-422c-ab00-92abe4ef6ea9\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource MedicinalProductDefinition &quot;89676a69-1fe7-422c-ab00-92abe4ef6ea9&quot; </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-pqcmc-routine-drug-product.html\">Routine Drug Product</a></p></div><p><b>identifier</b>: Example2BeadDrug</p><p><b>combinedPharmaceuticalDoseForm</b>: CAPSULE <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C25158)</span></p><p><b>route</b>: ORAL <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C38288)</span></p><blockquote><p><b>name</b></p><p><b>productName</b>: OXAZEPAM 30mg, PROPRANOLOL HYDROCHLORIDE 60mg</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>: OXAZEPAM</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>: 30mg</p><p><b>type</b>: strength 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>#STR)</span></p></blockquote><blockquote><p><b>part</b></p><p><b>part</b>: PROPRANOLOL HYDROCHLORIDE</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>: 60mg</p><p><b>type</b>: strength 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>#STR)</span></p></blockquote></blockquote></div>"
  },
  "identifier" : [
    {
      "value" : "Example2BeadDrug"
    }
  ],
  "combinedPharmaceuticalDoseForm" : {
    "coding" : [
      {
        "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
        "code" : "C25158",
        "display" : "CAPSULE"
      }
    ]
  },
  "route" : [
    {
      "coding" : [
        {
          "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
          "code" : "C38288",
          "display" : "ORAL"
        }
      ]
    }
  ],
  "name" : [
    {
      "productName" : "OXAZEPAM 30mg, PROPRANOLOL HYDROCHLORIDE 60mg",
      "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" : "OXAZEPAM",
          "type" : {
            "coding" : [
              {
                "system" : "http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2",
                "code" : "SCI"
              }
            ]
          }
        },
        {
          "part" : "30mg",
          "type" : {
            "coding" : [
              {
                "system" : "http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2",
                "code" : "STR"
              }
            ]
          }
        },
        {
          "part" : "PROPRANOLOL HYDROCHLORIDE",
          "type" : {
            "coding" : [
              {
                "system" : "http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2",
                "code" : "SCI"
              }
            ]
          }
        },
        {
          "part" : "60mg",
          "type" : {
            "coding" : [
              {
                "system" : "http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2",
                "code" : "STR"
              }
            ]
          }
        }
      ]
    }
  ]
}