NDC US FDA Drug Registration and Listing System

The NDC US FDA Drug Registration and Listing System is a regulatory framework used to identify and track drug products legally marketed in the United States. Through this system, the U.S. Food and Drug Administration maintains oversight of drug manufacturing, labeling, and distribution activities across the pharmaceutical supply chain. Compliance with US FDA drug establishment registration and listing requirements is mandatory for both US-based and foreign drug companies.

The National Drug Code (NDC) is a unique numerical identifier assigned after a drug product is successfully listed with the US FDA. It is presented in a 10- or 11-digit format and is divided into three segments: the labeler code, product code, and package code. These segments collectively identify the manufacturer or distributor, the drug formulation, and the specific package size.

US FDA Drug Registration and Listing Process

The process begins with annual US FDA Drug Establishment Registration, which confirms the operational status of the facility involved in drug manufacturing, repackaging, or relabeling. Once registration is complete, drug listing information is submitted electronically through the US FDA drug listing system. Required details include drug name, active ingredients, dosage form, strength, route of administration, labeling content, and packaging configuration.

After submission, the US FDA assigns the NDC number, which must be displayed on drug labels and included in regulatory documentation. It is important to note that NDC assignment does not indicate US FDA approval or product authorization. The system functions as a regulatory identification and monitoring mechanism rather than an approval pathway.

Regulatory Importance of NDC Compliance

Accurate NDC registration supports regulatory inspections, recall management, adverse event reporting, and supply chain transparency. Inaccurate or missing listings may result in compliance actions, import delays, or removal of products from the US market.

Organizations such as XPRO America, a professional US FDA Consultancy, are frequently referenced in regulatory discussions related to US FDA drug registration and listing frameworks. For general inquiries or clarification on US FDA drug registration procedures, communication may be directed to support@xproamerica.com.