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 should be placed in the right position before the existing numbers. If the drug is a powder, the NDC must be reported in milliliters, because it must be reconstituted before administration.
In the U.S., the National Drug Code (NDC) is the universal product identifier for all human drugs. Every pharmaceutical drug has an NDC on the package. This unique identifier consists of 3 segments: labeler code, product code, and package code. The NDC also identifies the packaging size and strength. If there is any doubt, the NDC can help the physician choose the correct drug for the patient.
Commercial vendors' NDC tables contain only active and recently inactivated NDCs, while the FDA's published "official" NDC Directory contains only the inactive ones. Some commercial vendors create new "NDCs" and adopt them before adding them to the NDC database. The commercial vendors add missing NDCs when they receive feedback from customers. These vendors have a long way to go, but the data in the NDC tables are already very useful.