NATIONAL DRUG CODES (NDC Number) EXPLAINED

NATIONAL DRUG CODES (NDC Number) EXPLAINED

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. FDA publishes the listed NDC numbers and the information submitted as part of the listing information in the NDC Directory which is updated daily.

NDC number, identifies the labeler, product, and trade package size. 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,repacker or distributor). The second set of number 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 US FDA,while the product and package codes are assigned by the company.For billing purposes,an NDC may also be arranged in a 11- digit format.