USFDA - NDC Number-- National Drug Code

USFDA - NATIONAL DRUG CODES (NDC Number)

In US market 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 human drugs in United states. NDC number, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. A labeler is any firm that manufactures (including repackers or relabelers), or distributes (under its own name) the drug. The first set of numbers in the NDC identifies the labeler (manufacturer, repackager, or distributer). The second set of numbers is the product code, which identifies the specific strength, dosage form (i.e, capsule, tablet, liquid) and formulation of a drug for a specific company. Finally, the third set is the package code, which identifies package sizes and types. The labeler code is assigned by the U.S. Food and Drug Administration (FDA), while the product and package code are assigned by the company. For billing or other purposes, an NDC may also be arranged in an 11-digit format.