NDC/NHRIC Labeler Code Assistance

NDC/NHRIC Labeler Code Assistance

The National Drug Code (NDC) Labeler Code is a critical identifier for drugs marketed in the U.S., assigned by the FDA. This 10-digit code plays an essential role in ensuring the regulatory compliance of pharmaceutical products, including prescription drugs, over-the-counter (OTC) drugs, cosmetics, and bulk drug ingredients.

The NDC is typically broken down into 3 parts:

1. Labeler Code (first 5 digits): Assigned by the FDA to the brand owner, packer, or manufacturer. This unique identifier helps ensure that the product is accurately linked to the company responsible for its distribution or manufacturing.
2. Product Code (next 4 digits): These digits, generated by the labeler, describe the specific formulation, strength, and dosage form of the drug.
3. Package Code (last digit): This final digit indicates the packaging of the drug, such as bottle size or number of tablets in a pack.

By obtaining an NDC Labeler Code, pharmaceutical companies gain a compliant path for listing products, maintaining accurate records, and ensuring consistent product distribution across U.S. markets.

The NDC Directory, along with the Drug Registration and Listing System (DRLS), plays a critical role in the identification and regulation of drug products in the U.S. The NDC is a standardized identifier for drugs and is a key element in ensuring that all drugs distributed in the United States are accurately cataloged, regulated, and compliant with the Drug Listing Act of 1972 and subsequent FDA regulations.

NDC Numbers are critical in the implementation and enforcement of the Drug Listing Act and other FDA regulations. They are used to track and ensure that drugs meet safety, efficacy, and quality standards. Regulatory agencies and healthcare professionals rely on the NDC Directory for various purposes, such as identifying drugs, monitoring adverse effects, and verifying drug information.

Masuu US Agent assists pharmaceutical companies by facilitating the registration and renewal of the NHRIC/NDC Labeler Code with the FDA. This ensures that drugs are properly listed and identified in accordance with the FDA’s regulatory requirements under 21 CFR 207.33.