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Reader task: you need to know what the FDA National Drug Code (NDC) Directory contains, how to search it, and what a listing does and does not prove. This page covers the directory as a platform; for how an NDC is built (labeler, product and package segments, 10-digit versus 11-digit forms) see What is an NDC?
What the FDA NDC Directory is
The NDC Directory is the FDA’s searchable listing of drug products identified by National Drug Code. According to the FDA’s directory page (content current as of 4 March 2026, read 7 November 2026), it contains information on active and certified finished and unfinished drugs that labelers have submitted to FDA in structured product labeling (SPL) listing files, and it is updated daily. SPL is the electronic format labelers use for listing and labeling; see structured product labeling (SPL).
Who runs it and what it covers
The directory is published by the FDA. Its content comes from labelers, not from FDA review: each labeler is responsible for the accuracy of its own entries.
What is included
- Finished prescription and over-the-counter drugs, whether approved or unapproved.
- Repackaged and relabeled drugs.
- Compounded products that were reported and assigned an NDC within the last two years.
- Unfinished drugs, which have their own search tab and download file.
- Only listings that are past their marketing start date and not past their marketing end date.
What is excluded
- Animal drugs and blood products.
- Drugs made under contract.
- Drugs marketed only as part of a kit, combination or inner layer and not sold individually.
- Non-drug products, because NDC assignment to them is prohibited.
The FDA also publishes an excluded-drugs data file among its downloads, which is the place to look when a product you expect is not found in the search.
How to search the directory
The search interface is on the FDA’s Drugs database site (the NDC page under accessdata.fda.gov, CDER). It has three tabs, and each tab offers different fields:
- Finished Products: Select Type, Proprietary Name, Application Number, Nonproprietary Name, NDC Code, Labeler.
- Unfinished Products: Select Type, Nonproprietary Name, NDC Code, Labeler.
- Compounded Products: Select Type, Nonproprietary Name, NDC Code, Establishment Information.
To look up a code, open the Finished Products tab and use the NDC Code field; to search by name use Proprietary Name or Nonproprietary Name. The same page links to the NDC API, the Data Files, Background Information and the FDA’s drug registration and listing instructions. Questions about the directory can be sent to the FDA address given on the search page ([email protected]).
Downloads and API
The FDA offers zipped downloads of the directory as text and Excel files, plus separate files for unfinished drugs, compounded drugs and excluded drugs, with definitions of the product and package files linked from the directory page. The openFDA project also exposes an NDC endpoint that returns data from the directory; openFDA converts the records to JSON and adds annotation fields, and its use is subject to openFDA’s Terms of Service.
Strengths and limits
- Strength: a free, official, daily-updated source for matching an NDC to a listed product, labeler and package.
- Not verification: the FDA states that inclusion is not FDA verification or approval of the information.
- Not approval: an NDC does not denote that a drug is approved.
- Not coverage: a listing is not proof of drug status or of Medicare, Medicaid or other payer coverage.
- Labeler-supplied: the labeler is responsible for each entry. FDA’s SPL implementation guidance also states that each January FDA inactivates human drug listings that were not certified and removes them from the directory, so a missing listing may simply be an uncertified one.
This is general reference information, not medical or dispensing advice.
Alternatives and companions
| Resource | What it holds | Note |
|---|---|---|
| FDA NDC Directory | Listing data from labelers’ SPL files: products, labelers, NDC packages | Not an approval list |
| DailyMed (NLM) | Submitted SPL labeling as HTML, PDF and XML, with bulk downloads and web services | NLM does not review SPL content before publication; shows “in use” labeling that may differ from FDA-approved labeling |
| openFDA NDC endpoint | Directory data as JSON with annotation fields | Not for medical-care decisions |
| FDALabel / FDA Online Label Repository | Labeling text drawn from DailyMed’s database, with different search and display | FDA describes FDALabel as covering over 140,000 labelings |
| NSDE file | Comprehensive NDC SPL Data Elements: listing data elements, not labeling text | Bulk data file |
FAQ
How do I look up an 11-digit or a 10-digit NDC?
Use the NDC Code field on the Finished Products tab. How the 10-digit labeler-product-package segments map to the 11-digit billing format is explained in What is an NDC?
Can I find discontinued NDCs?
The directory holds listings that are past their marketing start date and not past their marketing end date, so discontinued products are generally not in the searchable set. The FDA provides an excluded-drugs file among its downloads.
Is the directory the same as DailyMed?
No. Both draw on labeler SPL submissions, but the directory is built from listing data, while DailyMed publishes the submitted labeling documents.
Can I look up an NDC by CPT code?
The search fields listed above do not include CPT code, and the FDA does not describe a CPT crosswalk in the directory.
Sources
- FDA, National Drug Code Directory: https://www.fda.gov/drugs/drug-approvals-and-databases/national-drug-code-directory (content current as of 4 March 2026; read 7 November 2026)
- FDA, NDC search interface: https://www.accessdata.fda.gov/scripts/cder/ndc/index.cfm (read 7 November 2026)
- openFDA, Drug NDC: https://open.fda.gov/apis/drug/ndc/ (read 7 November 2026)
- FDA, SPL implementation guidance (January inactivation of uncertified listings; DailyMed, FDALabel and NSDE descriptions)
