Terminology owner/maintenance organisation

Name, contact details, website		Food and Drug Administration
Center for Drug Evaluation and Research
Office of Compliance, Immediate Office
Drug Registration and Listing Team
10903 New Hampshire Ave
Silver Spring, MD 20993-0002
Email: eDRLS@fda.hhs.gov

Formal name of the code system

National Drug Code (NDC)

Short name or abbreviation of the code system name

NDC
Technical identifier/s for the code system 

OID: 2.16.840.1.113883.6.69
Canonical URL: http://hl7.org/fhir/sid/ndc
URN:

Scope/domain statement for the code system

(Official or from HTA)

"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 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."

Link to information about the code system - including how to obtain the content

Information regarding the FDA published NDC Directory can be found here

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 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" 

Arrangement or agreements with HL7 for use of content

None
Version management - timing and identification of versions

The FDA Drug Directory of NDCs is published daily. Use the format YYYYMMDD to refer to a particular distribution. Implementers should note that any any point there are additional NDC codes that organizations have assigned but not yet reported to FDA. Therefore, a full set of NDCs (that exists in the marketplace) is unknown and cannot be versioned completely.


IP Information and Licensing Information

NDC codes have no copyright acknowledgment or license requirements.

HL7 users of this information - which HL7 products use this link (if known)

HL7 Pharmacy Work Group, HL7 Financial Management Work Group

Process to request content change

"To add a new entry, or to correct erroneous or incomplete product data in the NDC Directory, a labeler should submit a new SPL to update the information. See the eDRLS website for instructions on submitting SPL."

Other useful Information

"Current regulations require a registered establishment to update its drug listing data in June and December of each year, or, at the discretion of the establishment, when a change occurs (see 21 C.F.R. § 207.57(c)); therefore, FDA may not yet have been notified of recent changes before updating the NDC Directory. FDA makes every effort to prevent errors and discrepancies in the NDC Directory data."

"Each listed drug product is assigned a unique 10-digit, 3-segment number. This number, known as the NDC, identifies the labeler, product, and trade package size."

For certain purposes, including the proper billing of drug products, an 11-digit NDC may be required. The Centers for Medicare & Medicaid Services (CMS) and other government entities require an NDC as part of their billing claim form. Some government agencies, including HIPAA, may require the NDC in an 11-digit format with leading zeros. Increasingly, private payers require the 11-digit code, but rules can vary greatly.

  • The CMS NDC identifier is formatted as 11 digits with no spaces, hyphens or other characters.
  • If the NDC Package code is less than 11 digits (for example, a 4-4-2 structure) the code must be padded with leading zeros.
  • The leading zero is added to the needed section to create a 5-4-2 configuration.

An example of how the 10-digit and 11-digit formatted NDC relate is shown here as a reference. 

Information current as at (date)

20201026
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