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  1. Drug Approvals and Databases

National Drug Code Directory

On July 22, 2022, FDA announced the availability of Proposed Rule on Revising the National Drug Code Format.

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Directorio de Códigos Nacionales de Medicamentos (Spanish Version)

FDA’s National Drug Code (NDC) Directory contains information about finished drug products, unfinished drugs and compounded drug products.

Finished drug products

Drug establishments are required to provide FDA with a current list of all drugs manufactured, prepared, propagated, compounded or processed for sale in the U.S. at their facilities. Drugs are identified and reported using a unique, three-segment number called the National Drug Code (NDC) which serves as the FDA’s identifier for drugs. FDA publishes the listed NDC numbers in the NDC Directory which is updated daily.

The NDC Directory contains information on active and certified finished and unfinished drugs submitted to FDA in structured product labeling (SPL) electronic listing files by labelers. A labeler may be a manufacturer, including a repackager or relabeler, or the entity named on the product label.

The NDC Directory contains product listing data submitted for all finished drugs including prescription and over-the-counter drugs, approved and unapproved drugs and repackaged and relabeled drugs.

Unfinished drugs

Drug establishments producing active pharmaceutical ingredients are required to provide FDA with a current list of all drugs manufactured, prepared, propagated, compounded or processed in commercial distribution in the U.S. at their facilities.

The NDC unfinished drugs database contains product listing data submitted for all unfinished drugs, including active pharmaceutical ingredients, drugs for further processing and bulk drug substances for compounding.

Compounded drug products

The NDC Directory also includes information about finished compounded human drug products produced by outsourcing facilities that have elected to assign NDCs to their products. Outsourcing facilities – a type of drug compounding facility regulated under Section 503B of the FD&C Act – can be eligible for exemptions from drug registration and listing requirements if they meet the conditions under Section 503B. Outsourcing facilities may, but are not required to, assign NDCs to their finished compounded human drug products.

Outsourcing facilities are required to provide FDA with a list of drugs they compounded during the previous six-month period upon initial registration and in June and December each year. The NDC Directory draws data from these product reports.

The NDC Database only contains compounded drug products reported with the marketing category “Outsourcing Facility Compounded Human Drug Product (Exempt from Approval Requirements)” and that were assigned an NDC. Search results will include information reported to FDA within the last two years (last four reporting periods). *

*Inclusion of compounded drugs in the NDC Database coincides with the use of the marketing category “Outsourcing Facility Compounded Human Drug Product (Exempt from Approval Requirements)” beginning with the 2021-2 reporting period, i.e., June 01, 2021, thru November 30, 2021.

Important considerations about the NDC Directory

  • Inclusion in the NDC Directory does not indicate that FDA has verified the information provided or that the products are FDA approved. The content of each NDC Directory entry is the responsibility of the labeler submitting the SPL file.    
  • Assignment of an NDC number does not in any way denote FDA approval of the product. Any representation that creates an impression of FDA approval because a product has an NDC number is misleading and violates federal law.
  • Inclusion in the NDC Directory or assignment of an NDC number does not mean a product is a drug as defined by federal law.
  • Inclusion in the NDC Directory does not mean a product is covered or eligible for reimbursement by Medicare, Medicaid or other payers. Assignment of NDC number to non-drug products is prohibited.   
  • The NDC Directory does not contain all listed drugs. It does not include animal drugs, blood products, drugs manufactured under contract or drugs that are marketed solely as part of a kit or combination product or inner layer of a multi-level packaged product not marketed individually.
  • The NDC Directory contains product listings that have reached their marketing start date, but  have not yet reached marketing end date, if provided. Marketing start date is the date the labeler reports that the product has entered commercial distribution. A future date will prevent an NDC from being published until the date is reached. Marketing end date is provided by the labeler upon delisting to identify when the product is no longer in commercial distribution. A future marketing end date means the product has been delisted, but the NDC will remain active until that date is reached.
  • The NDC Directory contains compounded drug products reported using the marketing category “Outsourcing Facility Compounded Human Drug Product (Exempt from Approval Requirements)” and the assigned NDC within the last two years (last four reporting periods).

Adding, correcting or updating the NDC Directory

For finished drugs and unfinished drug products: Submit a new or updated product listing through SPL to add, correct or update product listing information in the NDC Directory. FDA does not submit or alter registration or listing data. Accuracy of the listing data is the responsibility of the company submitting the information to FDA. The agency monitors data accuracy and integrity through its compliance program. See the DRLS instructions for more information.

For compounded drugs: Outsourcing facilities submit product reports for compounded drugs twice a year and may update this data at any time. Outsourcing facilities should submit new or updated product reporting information through SPL to add, correct or update product reporting information that displays in the NDC Directory (see FDA guidance document on product reporting for outsourcing facilities).

Questions

See points of contact for drug registration and listing.

For drug compounding, contact Compounding@fda.hhs.gov.

Additional References

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