Help with PharmCatalyst's NDC Database Searches


What are the parts of an NDC?

The National Drug Code (NDC) has 3 parts, identifying the labeler/vendor, product, and package size.

The labeler code represents a company and is the group of numbers before the first dash. A labeler is any firm that manufactures, repacks or distributes a drug product.  If you don't know the labeler code for a company and you need it for a search of a company's drugs, you can get the labeler code (and product code) by doing an "NDC Search Using Brand Name" with any drug that you know that company markets.

The product code is the second part, often between two dashes. It corresponds to a drug, and identifies a specific strength, dosage form, and formulation for a particular firm.

The third segment, the package code, identifies package sizes.  Do not use the package code when searching the database.

An NDC in the FDA's database is always 10 numbers and will be in one of the following configurations: 4-4-2, 5-3-2, or 5-4-1. For consistency, some agencies, organizations or computer systems may display or want the NDC in an eleven digit format -- the labeler code as 5 digits with leading zeros if needed; the product code as 4 digits with leading zeros if needed; the package size as 2 characters with leading zeros when needed.

Why is the NDC that I'm looking for not found?

Maybe: 

  • the firm has not submitted the listing information to the FDA; 
  • the firm has notified the FDA that the product is no longer being marketed; 
  • firm has not complied fully with the listing process so the product is considered pending until complete information is provided in accordance with 21 CFR 207.

What is the source of the data and other info on this page?

The FDA.

Why did the search yield unexpected results?

Marketing agreements between/among pharmaceutical firms is a common cause. Not all NDCs in the FDA database are actually used in the marketplace.

How current is the Data?

The data is updated quarterly within 5 working days after the end of March, June, September, and December.