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

: DrugProductComponent example for an excipient - Maize starch - JSON Representation

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{
  "resourceType" : "Ingredient",
  "id" : "d01421cc-6488-468b-a676-d3e7281875e2",
  "meta" : {
    "profile" : [
      🔗 "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-component"
    ]
  },
  "text" : {
    "status" : "generated",
    "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Ingredient</b><a name=\"d01421cc-6488-468b-a676-d3e7281875e2\"> </a><a name=\"hcd01421cc-6488-468b-a676-d3e7281875e2\"> </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 Ingredient &quot;d01421cc-6488-468b-a676-d3e7281875e2&quot; </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-pqcmc-component.html\">Drug Product Component</a></p></div><p><b>status</b>: draft</p><p><b>role</b>: Inactive Ingredient <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C42637)</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-bd0f0a7a-27ea-4884-801d-bd0546e80888.html#urn-uuid-393a14e7-3edc-4373-bbe5-9e569d504a1c\">urn:uuid:393a14e7-3edc-4373-bbe5-9e569d504a1c</a></td></tr></table><h3>Strengths</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Extension</b></td><td><b>Presentation[x]</b></td><td><b>TextPresentation</b></td></tr><tr><td style=\"display: none\">*</td><td/><td>700 mg<span style=\"background: LightGoldenRodYellow\"> (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C28253 = 'mg')</span>/1 [arb'U]<span style=\"background: LightGoldenRodYellow\"> (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C75765 = '[arb'U]')</span></td><td>700mg</td></tr></table></blockquote></div>"
  },
  "status" : "draft",
  "role" : {
    "coding" : [
      {
        "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
        "code" : "C42637",
        "display" : "Inactive Ingredient"
      }
    ]
  },
  "substance" : {
    "code" : {
      "reference" : {
        "reference" : "urn:uuid:393a14e7-3edc-4373-bbe5-9e569d504a1c"
      }
    },
    "strength" : [
      {
        "extension" : [
          {
            "extension" : [
              {
                "url" : "strengthType",
                "valueCodeableConcept" : {
                  "coding" : [
                    {
                      "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
                      "code" : "C168628",
                      "display" : "Mass"
                    }
                  ]
                }
              },
              {
                "url" : "contentPercent",
                "valueDecimal" : 0.5828
              }
            ],
            "url" : "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/strength-extension"
          }
        ],
        "presentationRatio" : {
          "numerator" : {
            "value" : 700,
            "unit" : "mg",
            "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
            "code" : "C28253"
          },
          "denominator" : {
            "value" : 1,
            "unit" : "[arb'U]",
            "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
            "code" : "C75765"
          }
        },
        "textPresentation" : "700mg"
      }
    ]
  }
}