openFDA Drug NDC Directory

Every NDC record, labeler name, dosage form, route, marketing category and packaging configuration comes from the FDA's own listing file, served through the openFDA API. The FDA refreshes it on its own schedule, so a product approved this week may take several days to appear.

Because the data is self-reported by labelers, its text carries their conventions verbatim — inconsistent capitalisation, abbreviations, occasional typos. Names on this site are normalised for display only; the underlying values are unchanged.

Structured Product Labeling

Prescribing information — indications, dosage and administration, contraindications, warnings, adverse reactions — is drawn from the manufacturer's SPL submission. It is the label as filed, not a summary or an interpretation.

ClinicalTrials.gov

Trial records, phases, recruiting status, sponsors and eligibility criteria come from the ClinicalTrials.gov API. Registry entries are maintained by sponsors, so a status of recruiting reflects the last time the sponsor updated the record.

The HCPCS crosswalk

J-code assignments, descriptors and billable units are maintained here against the CMS HCPCS Level II file, which updates quarterly. Crosswalks between a drug and its code are the one part of this site that is editorial rather than fetched, so verify against the current CMS file before submitting a high-value claim.

What this site is not

It is a reference for identifiers, not a pricing service and not clinical advice. Nothing here reflects a specific payer's fee schedule, coverage policy or authorisation requirements, all of which vary by contract.