What is NDC Number for Prescription Medicines? The NDC Directory contains information for prescription and over-the-counter (OTC) medications, insulin products, and other items manufactured and marketed in the United States. The directory includes product names that are listed in accordance with the Drug Listing Act (DLA) and the regulatory standards of the Food and Drug Administration (FDA). However, some drug products are excluded from the NDC Directory due to incomplete listing obligations or other reasons.
To determine which drugs should be labeled with a US NDC, it's important to know how the FDA defines this code. The first five digits of an NDC come from the labeler code, which the FDA assigns to the manufacturer, distributor, or private label company. The NDC is assigned after a drug has been listed with the agency. For drug companies that are not familiar with the process, FDAbasics will prepare the application. Once approved, the FDA will assign the NDC within ten business days. NDCs must be submitted for all physician-administered drugs. They are usually displayed on the medicine container. The format should be 5-4-2, though some packages display less than eleven digits. To submit an NDC, the four-digit number