The National Drug Code (NDC) is a unique 11-digit identifier assigned to every medication approved for sale in the United States. This code is a product of the Food and Drug Administration (FDA) and serves as a universal standard for identifying drugs.
The NDC is formatted as a three-segment number, with a 5-4-2 format. The segments represents the labeler (manufacturer; 5 digits), product (specific strength, dosage form, and formulation; 4 digits), and package (size and type; 2 digits) of a drug, respectively. This coding system helps in organizing drug information and facilitates the tracking of medications.
The FDA publishes all registered NDC numbers in the NDC Directory, which receives daily updates. This directory includes information for all completed drug products, encompassing over-the-counter medications, prescription medications, drugs without FDA approval, those that have been approved, and drugs that have been repackaged or relabeled.
It is crucial to understand that being listed in the NDC Directory does not imply that a drug has received FDA approval.
The NDC enhances the safety and efficiency of drug distribution and use. It enables healthcare providers, pharmacies, and insurers to accurately identify and manage medications, thereby reducing errors in prescribing, dispensing, and administering drugs.
The NDC system also supports drug recalls, monitoring, and reporting by providing a precise way to reference specific products.
It also simplifies the process of billing and reimbursement by ensuring that the drugs billed are clearly identified. Specifically for Medicare claims, hospitals are required to provide the precise NDC for drugs given to patients; without this information, the Centers for Medicare & Medicaid Services (CMS) will not provide reimbursement.