National Drug Code (NDC) Level Information Data

A vital part of FDA and CDER’s mission is to promote and protect the public health. Offices within CDER take a variety of approaches to meet these broad goals. For example, the Office of Surveillance and Epidemiology (OSE) evaluates drug risks and promotes the safe use of drugs by the American people. The Division of Medication Error, Prevention and Analysis (DMEPA) aims to increase the safe use of drug products by minimizing use error that is related to the naming, labeling, product design, or packaging of drug products with the goal of eliminating medication errors in the United States healthcare system. To fulfill these missions and other program functions, CDER requires access to NDC-level data to accurately characterize each FDA-regulated product active or previously active in the U.S. marketplace, down to the level of the active ingredients, inactive ingredients, strength, dosage formulation, manufacturer, and packaging. Access to these data allows the FDA to respond to post-marketing issues related to naming, route, strength, dosage form, labeling, product design, or packaging of drug products to increase the safe use of drug products by assessing safety risks and evaluating the effectiveness of strategies to mitigate those risks.