National Drug Code Directory

Search the National Drug Code Directory

FDA’s National Drug Code (NDC) directory contains information about finished, unfinished (e.g., active pharmaceutical ingredients) and compounded drugs. Visit FDA’s Proposed Rule on Revising the National Drug Code format for more information.

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 as well as repackaged and relabeled drugs.

Drug establishments are required to provide FDA with a current list of all drugs including active pharmaceutical ingredients (API) 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 NDC which serves as the FDA’s identifier for drugs. FDA publishes the listed NDC numbers in the NDC directory which is updated daily.

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, 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 and have not reached marketing end date.
- Marketing start date is the date that the drug is reported to enter U.S. commercial distribution. A future marketing start date will prevent publication of an NDC until the date is reached. Marketing end date is included when a drug is discontinued from U.S. 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 and the assigned NDC within the last two years.

Compounded drugs

Outsourcing facilities that have elected to assign NDCs to their products 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.

Outsourcing facilities may update their information through SPL at any time to add, correct or update product reporting information. Visit FDA’s guidance document on product reporting for outsourcing facilities for more information.

Adding, correcting or updating the NDC Directory

For finished and unfinished drugs: 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. Visit 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.

Questions

Visit points of contact for establishment registration and drug listing.
Contact compounding@fda.hhs.gov for questions related to compounded drugs.