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Drugs@FDADrugs@FDA (Approved Drug Products)
U.S. Food & Drug Administration (openFDA) · Tier-1 · research-only (never on individual profiles)
Drugs@FDA is the openFDA catalog of FDA-approved drug products — application number, sponsor, brand and generic name, dosage form, route, and marketing status. Fonteum keys each row on application number and product number.
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.
What this source does NOT mean
An approval record describes a drug product and its sponsor — it is not a statement about any healthcare provider, not a clinical recommendation, and not a Fonteum endorsement of a product. A named sponsor is not an asserted provider-identity match.
Research and data questions this source supports.
- Resolve an FDA application number to its sponsor, brand and generic name, dosage form, and marketing status.
- Build a drug-product reference that distinguishes prescription, OTC, and discontinued products by marketing status.
- Cross-reference a sponsor's approved-product portfolio against Part D spending and NDC directory entries.
- Power 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.
Fields listed below show their configured `display_allowed` flag from the §94 provenance schema. Fields marked write-locked are captured for audit and are not rendered on profile pages.
Research-only — never on profiles
6 fieldsWhat 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, publisher cadence.
Authority
U.S. Food & Drug Administration (openFDA)
Tier
Tier-1 · research-only (never on individual profiles)
Publisher / configured cadence
Declared or configured cadence: Weekly — openFDA republishes the Drugs@FDA partition. Not evidence of the latest loaded source date.
License
openFDA — CC0 public domain (U.S.-government works). Free to use; no API key required for bulk downloads. License ↗
Official URL
Attribution requirement
Source: U.S. Food & Drug Administration (openFDA) — Drugs@FDA · Snapshot {YYYY-MM-DD}
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. Snapshot and attestation fields must be read from the specific artifact; no provenance fact currently links deterministically to a signature.
What a single field looks like in the graph.
This worked example shows the provenance shape used when a surfaced field has populated source, last-checked, display-rule, and confidence metadata. Individual fields may omit unavailable values.
Field
Approved drug product (research-only)
Sample value
NDA 000000 · Example Brand (generic) · Tablet · Prescription
Provenance line
Source: openFDA Drugs@FDA · Snapshot 2026-06-14 · Methodology fda-drugs-at-fda/v1 · Display rule: product-keyed research reference
Official API, bulk download, and Fonteum endpoints.
Official API / download
Fonteum surface
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; Loaded dates must be read from the specific response; publisher cadence is not proof of a completed load. 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 → The generated source-catalog subset — documented datasets Fonteum cites.
- /data-provenance → The provider graph — pipeline diagram, source-family clusters, field-level provenance examples, display rules.
- /methodology → Documented sourcing, publisher cadence, observed freshness, and corrections policy.
- /editorial-policy → Independence, sourcing, conflicts, corrections, retractions.