U.S. FDA Registration & Labeling Compliance Assistance

FDA National Drug Code NDC

The United States' Drug Listing Act of 1972 requires registered drug establishments to provide the FDA with a current list of all drugs manufactured, prepared, propagated, compounded, or processed for commercial distribution. Drug products are identified and reported using a unique 10 digit , three-segment number, called the National Drug Code (NDC Labeler code), 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 to public.

Related Page: OTC Drug Establishment Registration and OTC Drug Listing

 The first 5 numeric characters of the 10-character NDC code identify the manufacturer or distributor and are known as the Labeler Code. This part is assigned by FDA. The last 5 numeric characters of the 10-character code identify the drug and the trade package size and type. The segment that identifies the drug formulation is known as the Product Code and the segment that identifies the trade package size and type is known as the Package Code. The manufacturer or distributor will assign the Product Code and the Package Code before drug listing.

In order to obtain NDC Labeler code the drug manufacturers should submit a request in SPL (Structured Product Labeling) format via FDA's Electronic Submission Gateway or ESG. In order to successfully submit the SPL drug manufacturers also should have a U.S. agent. FDA Listing Inc. can act as the U.S. agent as well as assisting drug manufacturers to prepare and submit the SPL file to obtain the NDC Labeler code. Click the start button to inquire assistance for NDC Labeler code.