Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
2.0.0 - STU2

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 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

## : Substance Name Type - JSON Representation

Page standards status: Trial-use | Maturity Level: 2

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    {
      "resourceType" : "ValueSet",
      "id" : "pqcmc-substance-name-type",
      "text" : {
        "status" : "generated",
        "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p class=\"res-header-id\"><b>Generated Narrative: ValueSet pqcmc-substance-name-type</b></p><a name=\"pqcmc-substance-name-type\"> </a><a name=\"hcpqcmc-substance-name-type\"> </a><ul><li>Include these codes as defined in <a href=\"http://terminology.hl7.org/6.4.0/CodeSystem-v3-nciThesaurus.html\"><code>http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl</code></a><table class=\"none\"><tr><td style=\"white-space:nowrap\"><b>Code</b></td><td><b>Display</b></td></tr><tr><td>C71898</td><td>Brand</td></tr><tr><td>C97054</td><td>Generic Name</td></tr><tr><td>C203355</td><td>GSRS Preferred Term</td></tr><tr><td>C203357</td><td>Systematic Name</td></tr><tr><td>C203358</td><td>USP-NF Established Name</td></tr><tr><td>C54682</td><td>CAS Number</td></tr><tr><td>C142585</td><td>INN</td></tr><tr><td>C96973</td><td>USAN</td></tr><tr><td>C203356</td><td>IUPAC Name</td></tr><tr><td>C95517</td><td>ISBT-128 DIN</td></tr><tr><td>C203354</td><td>Company ID/Code</td></tr></table></li></ul></div>"
      },
      "extension" : [
        {
          "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg",
          "valueCode" : "brr"
        },
        {
          "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm",
          "valueInteger" : 2,
          "_valueInteger" : {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-conformance-derivedFrom",
                "valueCanonical" : "http://hl7.org/fhir/us/pq-cmc-fda/ImplementationGuide/hl7.fhir.us.pq-cmc-fda"
              }
            ]
          }
        },
        {
          "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
          "valueCode" : "trial-use",
          "_valueCode" : {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-conformance-derivedFrom",
                "valueCanonical" : "http://hl7.org/fhir/us/pq-cmc-fda/ImplementationGuide/hl7.fhir.us.pq-cmc-fda"
              }
            ]
          }
        }
      ],
      "url" : "http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-substance-name-type",
      "identifier" : [
        {
          "system" : "urn:ietf:rfc:3986",
          "value" : "urn:oid:2.16.840.1.113883.4.642.40.36.48.27"
        }
      ],
      "version" : "2.0.0",
      "name" : "PqcmcSubstanceNameType",
      "title" : "Substance Name Type",
      "status" : "active",
      "experimental" : false,
      "date" : "2025-07-03T13:07:08+00:00",
      "publisher" : "HL7 International / Biomedical Research and Regulation",
      "contact" : [
        {
          "name" : "HL7 International / Biomedical Research and Regulation",
          "telecom" : [
            {
              "system" : "url",
              "value" : "http://www.hl7.org/Special/committees/rcrim"
            },
            {
              "system" : "email",
              "value" : "brr@lists.HL7.org"
            }
          ]
        }
      ],
      "description" : "A category of terminology used to qualify the information pertaining to the type of substance name in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents.",
      "jurisdiction" : [
        {
          "coding" : [
            {
              "system" : "urn:iso:std:iso:3166",
              "code" : "US",
              "display" : "United States of America"
            }
          ]
        }
      ],
      "compose" : {
        "include" : [
          {
            "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
            "concept" : [
              {
                "code" : "C71898",
                "display" : "Brand"
              },
              {
                "code" : "C97054",
                "display" : "Generic Name"
              },
              {
                "code" : "C203355",
                "display" : "GSRS Preferred Term"
              },
              {
                "code" : "C203357",
                "display" : "Systematic Name"
              },
              {
                "code" : "C203358",
                "display" : "USP-NF Established Name"
              },
              {
                "code" : "C54682",
                "display" : "CAS Number"
              },
              {
                "code" : "C142585",
                "display" : "INN"
              },
              {
                "code" : "C96973",
                "display" : "USAN"
              },
              {
                "code" : "C203356",
                "display" : "IUPAC Name"
              },
              {
                "code" : "C95517",
                "display" : "ISBT-128 DIN"
              },
              {
                "code" : "C203354",
                "display" : "Company ID/Code"
              }
            ]
          }
        ]
      }
    }