Drugs@FDA (Approved Drug Products)

How this source shows up on Fonteum.

Aggregate drug-product reference, keyed to the sponsor / manufacturer (name-normalized for a deferred Open Payments cross-link). Fonteum surfaces the approved-product identity and marketing status; the entity-graph link is held for ambiguous matches, never written.

Research and data questions this source supports.

• 01Resolve an FDA application number to its sponsor, brand and generic name, dosage form, and marketing status.
• 02Build a drug-product reference that distinguishes prescription, OTC, and discontinued products by marketing status.
• 03Cross-reference a sponsor's approved-product portfolio against Part D spending and NDC directory entries.
• 04Power a research surface on approved-product counts by sponsor or dosage form.

Dataset size: 51,713 approved drug products (2026-06-14 snapshot)

Per-field display contract.

Every field below has a `display_allowed` flag in the §94 provenance schema. Write-locked fields are captured to provenance for audit but never rendered on profile pages.

What we can’t infer from this source.

• Tier-1 — aggregate research context only; never rendered on individual provider profiles.
• Product-keyed by application/product number; sponsor is name-keyed, with the entity-graph cross-link deferred.
• Marketing status reflects the source at snapshot time (e.g. Prescription, Discontinued); it is not real-time.
• openFDA omits empty fields; some historical applications carry sparse product detail.

Authority, license, refresh cadence.

What the source allows.

openFDA data is CC0 public domain. No API key is required for bulk downloads; attribution to openFDA is the courtesy ask. Fonteum pulls the Drugs@FDA partition and attests each snapshot.

What a single field looks like in the graph.

A worked example. Every field surfaced from this source carries this shape of provenance line — source · last checked · display rule · confidence (when applicable).

Official API, bulk download, and Fonteum endpoints.

Common questions about Drugs@FDA.

What is Drugs@FDA?

Drugs@FDA is the openFDA catalog of FDA-approved drug products. Each row carries the FDA application number, product number, sponsor, brand and generic name, dosage form, route, and marketing status. Fonteum keys each row on application number and product number.

How do I download Drugs@FDA data?

The data is available from the openFDA Drugs@FDA API (api.fda.gov/drug/drugsfda.json) and as a bulk download from open.fda.gov. It is CC0 public domain — free to download and redistribute with attribution, with no API key required.

Does an approved product mean it is currently marketed?

Not necessarily. The marketing_status field distinguishes Prescription, Over-the-counter, and Discontinued products. An approval record is historical; the marketing status reflects the source at snapshot time and is not real-time.

Is this linked to prescribers or providers?

No. Drugs@FDA is product- and sponsor-keyed; the sponsor is recorded by name. There is no NPI in the source, and the Open Payments manufacturer cross-link is deferred — ambiguous matches are held, not written.

How fresh is Fonteum's copy?

openFDA republishes the Drugs@FDA partition on a roughly weekly cadence; Fonteum re-pulls on snapshot publication. As of the 2026-06-14 snapshot, Fonteum holds 51,713 approved drug products.

Where this source already shows up.

Related sources in the graph

• /sources/fda-enforcement-reports →
• /sources/fda-drug-ndc →
• /sources/cms-part-d-spending-by-drug →

• /sources → The full source library — every dataset Fonteum cites.
• /data-provenance → The provider graph — pipeline diagram, source-family clusters, field-level provenance examples, display rules.
• /methodology → Network-wide sourcing, refresh cadence, and corrections policy.
• /editorial-policy → Independence, sourcing, conflicts, corrections, retractions.