What organization assigns the National Drug Code (NDC)?

The National Drug Code (NDC) is assigned by the manufacturer of the drug. The NDC serves as a unique identifier for medications approved by the FDA and is crucial for various aspects of drug regulation, including tracking and billing.

Manufacturers are responsible for applying for their own NDC numbers when they produce a new drug. The code itself comprises three segments that indicate the labeler, product, and package size, which helps distinguish between different products, strengths, and packaging types.

While organizations such as the FDA and CDER (Center for Drug Evaluation and Research) regulate and oversee the drug approval process, it is ultimately the responsibility of the manufacturer to create and submit the NDC. The DEA (Drug Enforcement Administration) is involved in regulating controlled substances but does not directly assign NDCs. Understanding that the manufacturer plays a pivotal role in the assignment of the NDC provides insight into the drug approval and marketing processes.