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This page is part of the Da Vinci Payer Data Exchange (v2.0.0: STU2) based on FHIR (HL7® FHIR® Standard) R4. This is the current published version. For a full list of available versions, see the Directory of published versions

: FDA National Drug Code (NDC) - XML Representation

Active as of 2024-01-06

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<ValueSet xmlns="http://hl7.org/fhir">
  <id value="FDANationalDrugCode"/>
  <text>
    <status value="generated"/>
    <div xmlns="http://www.w3.org/1999/xhtml"><ul><li>Include all codes defined in <a href="http://terminology.hl7.org/5.0.0/CodeSystem-v3-ndc.html"><code>http://hl7.org/fhir/sid/ndc</code></a></li></ul></div>
  </text>
  <extension
             url="http://hl7.org/fhir/StructureDefinition/structuredefinition-wg">
    <valueCode value="fm"/>
  </extension>
  <url
       value="http://hl7.org/fhir/us/davinci-pdex/ValueSet/FDANationalDrugCode"/>
  <version value="2.0.0"/>
  <name value="FDANationalDrugCode"/>
  <title value="FDA National Drug Code (NDC)"/>
  <status value="active"/>
  <experimental value="true"/>
  <date value="2024-01-06T03:22:26+00:00"/>
  <publisher value="HL7 International / Financial Management"/>
  <contact>
    <name value="HL7 International / Financial Management"/>
    <telecom>
      <system value="url"/>
      <value value="http://www.hl7.org/Special/committees/fm"/>
    </telecom>
    <telecom>
      <system value="email"/>
      <value value="fm@lists.HL7.org"/>
    </telecom>
  </contact>
  <contact>
    <name value="Mark Scrimshire (mark.scrimshire@onyxhealth.io)"/>
    <telecom>
      <system value="email"/>
      <value value="mailto:mark.scrimshire@onyxhealth.io"/>
    </telecom>
  </contact>
  <contact>
    <name value="HL7 International - Financial Management"/>
    <telecom>
      <system value="url"/>
      <value value="http://www.hl7.org/Special/committees/fm"/>
    </telecom>
  </contact>
  <description
               value="The Drug Listing Act of 1972 requires registered drug establishments to provide the Food and Drug Administration (FDA) with a current list of all drugs manufactured, prepared, propagated, compounded, or processed by it for commercial distribution.  (See Section 510 of the Federal Food, Drug, and Cosmetic Act (Act) (21 U.S.C. § 360)). Drug products are identified and reported using a unique, three-segment number, called the National Drug Code (NDC), which serves as a universal product identifier for drugs. FDA publishes the listed NDC numbers and the information submitted as part of the listing information in the NDC Directory which is updated daily.

The information submitted as part of the listing process, the NDC number, and the NDC Directory are used in the implementation and enforcement of the Act.

Users should note:

Starting June 1, 2011, only drugs for which electronic listings (SPL) have been submitted to the FDA are included in the NDC Directory. Drugs for which listing information was last submitted to FDA on paper forms, prior to June 2009, are included on a separate file and will not be updated after June 2012.

Information regarding the FDA published NDC Directory can be found [here](https://www.fda.gov/drugs/drug-approvals-and-databases/national-drug-code-directory)

Users should note a few important items

*   The NDC Directory is updated daily.
*   The new NDC Directory contains ONLY information on final marketed drugs submitted to the FDA in SPL electronic listing files by labelers.
*   The NDC Directory does not contain all listed drugs. The new version includes the final marketed drugs which listing information were submitted electronically. It does not include animal drugs, blood products, or human drugs that are not in final marketed form, such as Active Pharmaceutical Ingredients(APIs), drugs for further processing, drugs manufactured exclusively for a private label distributor, or drugs that are marketed solely as part of a kit or combination product or inner layer of a multi-level packaged product not marketed individually. For more information about how certain kits or multi-level packaged drugs are addressed in the new NDC Directory, see the NDC Directory Package File definitions document. For the FDA Online Label Repository page and additional resources go to: [FDA Online Label Repository](https://labels.fda.gov/)"/>
  <jurisdiction>
    <coding>
      <system value="urn:iso:std:iso:3166"/>
      <code value="US"/>
      <display value="United States of America"/>
    </coding>
  </jurisdiction>
  <copyright
             value="NDC codes have no copyright acknowledgment or license requirements."/>
  <compose>
    <include>
      <system value="http://hl7.org/fhir/sid/ndc"/>
    </include>
  </compose>
</ValueSet>