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NDC Number — National Drug Code

An NDC (National Drug Code) number is a unique 10-digit identifier assigned to each drug product in the United States. It is required in the FDA drug listing.

10-Digit Unique CodeRequired For Drug Listing3-Segment FormatSince 2009
ndc number anatomy

What is an NDC Number?

An NDC (National Drug Code) number is a unique 10-digit identifier for a specific drug product in the United States. The NDC number is a mandatory requirement for drug product listing.

The NDC number consists of three segments: (1) Labeler Code — 4 or 5 digits identifying the drug labeler (manufacturer, re-packer, or re-labeler); (2) Product Code — 3 or 4 digits identifying the specific strength, dosage form, and formulation; (3) Package Code — 1 or 2 digits identifying the package size and type.

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The NDC Labeler Code is assigned by the FDA as part of the drug listing process. Once you have a labeler code, you assign the product code and package code segments.

Every OTC, prescription, animal, and homeopathic drug and API product sold in the USA must have an NDC number.

  • Labeler Code (4-5 digits) — assigned by FDA before drug listing
  • Product Code (3-4 digits) — assigned by the labeler for each specific product
  • Package Code (1-2 digits) — assigned by the labeler for each package size
  • NDC format — XXXXX-XXX-XX (10 digits total)
  • If printed on the label — must follow the FDA guidance

Information required for NDC Number request

    • Labeler Name
    • DUNS Number

FDA use DUNS number to verify the establishment address.

    • Contact Name & Address

Address includes Street, city, State, Postal code, Country, Phone and email.

    • Labeler Address

Address of the labeler including Street, city, State, Postal code and Country.

    • Business Operation

Identify the Type of business.

    • US Agent

Each foreign establishment should have a US agent.

 

SPL File Submission

After preparing the SPL file for NDC Labeler code request, it is submitted to FDA via Electronic Submission Gateway (ESG). Requests for NDC Labeler Codes are individually evaluated prior to entry into the NDC system. The initial submission for NDC Labeler Code is reviewed by FDA. Once the evaluation is completed, FDA will assign the first 5 digits of the NDC Labeler code which represents the establishment. After FDA assign the labeler code, the previous SPL file is resubmitted with assigned labeler code.

Frequently Asked Questions

Common questions about FDA NDC Numberr.
If you are a drug manufacturer or labeler who plans to market your products in the USA, you can submit an NDC request SPL to the FDA.
No. The NDC labeler code is only the first segment. The complete NDC number includes all three segments.
Dietary supplements regulated as food do not use NDC numbers. Only products registered as drug products require NDC numbers.
Yes. LMG handles drug establishment registration and NDC labeler code assignment for domestic and foreign manufacturers.

Need an NDC Number?

LMG handles FDA drug establishment registration and NDC labeler code assignment for OTC drug manufacturers worldwide.

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