What is the Origin of National Drug Code?

The NDC system was mandated by the Drug Listing Act of 1972, requiring all drug establishments to register their products with the FDA. This regulatory origin established a universal coding standard to maintain an accurate, comprehensive database of all marketed drugs, facilitating regulatory oversight and preventing medication errors. The structure is rooted in the need for a hierarchical identification system for complex pharmaceutical inventories.

What is the Mechanism of National Drug Code?

The NDC functions as a critical mechanism for unambiguous identification of a drug product from manufacturing through dispensing and billing. The code is placed on all drug packaging and serves as the primary data element for electronic health records and pharmacy management systems, ensuring that the exact formulation and strength of a hormonal preparation are dispensed to the patient. Its structure allows for efficient data aggregation and analysis by regulatory bodies to monitor drug utilization and safety.

National Drug Code ∞ Area

National Drug Code

Meaning

The National Drug Code (NDC) is a unique, three-segment numerical identifier assigned by the U.S. Food and Drug Administration (FDA) to all commercially available human drug products in the United States. This standardized code is essential for product identification, regulatory reporting, prescribing, and reimbursement across the pharmaceutical supply chain. Each segment of the 10- or 11-digit code specifies the labeler (manufacturer), the product (specific strength, dosage form, and formulation), and the package size, ensuring precise tracking of all hormonal and other medications.