FDA RFQ: National Drug Code (NDC) Level Information Data

Notice ID: 75F40123Q00191

Description

A vital part of FDA and CDER’s mission is to promote and protect the public health. Offices within CDER take a variety of approaches to meet these broad goals. For example, the Office of Surveillance and Epidemiology (OSE) evaluates drug risks and promotes the safe use of drugs by the American people. The Division of Medication Error, Prevention and Analysis (DMEPA) aims to increase the safe use of drug products by minimizing use error that is related to the naming, labeling, product design, or packaging of drug products with the goal of eliminating medication errors in the United States healthcare system.

NDC-Level Data Requirements

For this requirement, the data resource(s) shall be sufficient to meet FDA’s need to analyze NDC-level data. The data resource(s) shall capture the following data elements

1. The company-specific data elements shall include (but are not limited to): name of corporation (parent company); name of manufacturer (marketing company).
2. The drug-specific data elements shall include for all approved and unapproved prescription and nonprescription (e.g., homeopathic medications, dietary supplements, medical foods, and other over-the-counter (OTC)) products which are assigned a primary (e.g., container that holds the product, unit of use) or secondary (packaging that holds the primary packaging, unit of sale) NDC:
   1. product names (U.S. proprietary and non- proprietary)
   2. synonyms (e.g., Vitamin C as a synonym for ascorbic acid)
   3. brand status (brand, generic and branded generic), Rx status (Rx, OTC)
   4. originator status (e.g., originator, re-packager, branded or private label, etc.)
   5. active ingredient(s)
   6. inactive ingredients…

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