NDC Number

NDC Number refers to the National Drug Code number which is the FDA’s unique identifier for drugs. This number refers to the drugs listed in the NDC Directory.

Every drug that is manufactured, prepared, propagated, compounded, or processed for sale in the U.S.A. must have its own unique NDC number. NDC number is a 10 digit number divided into 3 different segments, the first four numbers represent labeler code, the next four numbers represent the product and the final 2 numbers represent the packing details.

ALL NDC Numbers are included in NDC directory and this directory provides data on active drugs, certified finished and unfinished drugs submitted to FDA.

There are 3 basic steps to get your product a NDC number

• Labeler Code Registration- This number is given by the FDA to your organization and it will remain constant
• Establishment Registration – FDA requires each plant to be registered with FDA before a Labeler code can be generated. Visit FDA Registration Page for more details on this step
• Preparation and Submission of SPL (Structured Product Labeling) to FDA.

SPL Contains all the details of the product for which NDC is requested. SPL has to be submitted in extensible markup language (XML) files

FDA also requires an annual update for Establishment registration and periodic update i.e in June and December of each year for the drug listed in NDC.

It is a mandatory requirement for drug companies engaged in manufacturing, repacking, relabeling, or salvaging drug products for selling in US to register their establishment with US FDA and list their products in NDC Directory.