NDC/NHRIC Labeler Code Assistance
The National Drug Code (NDC Labeler Code) is a 10-digit identification number assigned by the FDA to each drug product marketed in the United States, whether over the counter (OTC) or prescription.
This number is essential for listing Rx, OTC, cosmetics, and bulk ingredients with the USFDA. The NDC is divided into two parts: the first five digits, known as the labeler code, are assigned by the FDA to the brand owner, packer, and/or manufacturer of the drug.
The second five digits are generated by the labeller company based on the drug formulation and packaging data. Masuu US Agent assists pharmaceutical companies in registering and renewing the NHRIC/NDC Labeller Code with the USFDA.
This process ensures compliance with the regulatory requirements outlined in 21 CFR 207.33. By securing the unique 5-digit labeller code and corresponding NDC numbers for each drug, companies can ensure accurate product identification and maintain regulatory compliance.