FDA Drug and Biologic Knowledge Graph
FDA drug and biologic regulatory data as RDF, keyed on the application number (NDA, ANDA, BLA): Drugs@FDA, the NDC Directory, the Orange Book, the Purple Book, NSDE, SPL drug labels, drug shortages, complete response letters, establishment registries, inactive ingredients and drug master files, linked to FDA substances.
The FDA Drug and Biologic Knowledge Graph publishes the U.S. Food and Drug Administration's drug and biologic approval, listing, labeling and marketing data as linked data, 59.4 million triples. Every source field is kept, and every record carries its source dataset, record ID, source URL and download date. Named contact persons in the establishment registries are never ingested.
The hub is the application. fdadrug:DrugApplication, IRI https://bmedesign.org/fda-drug-biologic-kg/id/application/<nda|anda|bla><6 digits> (for example .../application/nda021234). Every source that names an application number is normalized to this one IRI, so a query can start from any of them: Drugs@FDA (29,383 applications from openFDA and the Drugs@FDA data files), the NDC Directory (fdadrug:hasApplication), the Orange Book, the Purple Book (BLAs), NSDE, SPL labels, drug shortages and complete response letters.
Products, submissions and documents. Under each application: .../product/<product number> (fdadrug:DrugProduct, also typed fdadrug:OrangeBookProduct when the Orange Book lists it) with marketing status and therapeutic-equivalence codes; .../submission/<type>-<number> (fdadrug:Submission, with status, status date, class and review priority) and its documents (fdadrug:ApplicationDocument, with the accessdata URL of each letter, label or review); Orange Book patents (fdadrug:OrangeBookPatent, with expiry date and use code) and exclusivities under their product. From the Purple Book, both the monthly change rows (fdadrug:PurpleBookChange, 5,505) and the current licensed-product list (fdadrug:PurpleBookProduct, 2,251) sit under their BLA.
Labels. fdadrug:DrugLabel (262,902 current SPL label sets from openFDA drug/label, IRI .../label/<set id>): every labeling section as text (indications, dosage, warnings, adverse reactions, clinical pharmacology and the rest), the SPL metadata and openFDA's harmonized fields, linked to the application, the package NDCs and the substances.
NDC listings. fdadrug:NdcProduct (138,419 products, IRI .../ndc-product/<product_id>) with labeler, dosage form, route, marketing category, active ingredients and openFDA's harmonized fields (RxCUI, SPL set ID, pharmacologic class); the NDC Directory's unfinished, excluded and compounder companion files are included. Package NDCs are shared nodes, .../ndc-package/<package ndc> (fdadrug:NdcPackage): the NDC Directory packaging list, the NSDE listing (670,521 packages, with marketing start and end dates), labels and drug shortages all point at the same node.
Establishments, ingredients, files. fdadrug:DrugEstablishment (DECRS registrations, keyed to FEI firm nodes in fda-compliance-kg), fdadrug:BloodEstablishment (CBER eBER) and fdadrug:HctpEstablishment (CBER eHCTERS, with functions, listings and donor information), fdadrug:InactiveIngredientRecord (9,076 rows of the Inactive Ingredient Database with its change log), fdadrug:DrugMasterFile (41,672 DMFs), fdadrug:OutsourcingFacility (98 registered 503B facilities), fdadrug:LicensedVaccine (96) and fdadrug:CellularGeneTherapyProduct (54).
Shortages and letters. fdadrug:DrugShortage (1,580 rows: status, reason, availability, update dates) linked to package NDCs and applications; fdadrug:CompleteResponseLetter (458 letters from FDA's transparency release, with the letter text).
Every link resolves. 8,481 stub nodes (fdadrug:isStub true) stand in for 4,740 applications, 3,577 package NDCs and 164 NDC products that other sources reference but Drugs@FDA and the NDC Directory do not list, so no link points to an untyped IRI.
Links to other graphs. fdadrug:hasSubstance links products, applications, labels and shortages to fda-substance-kg by UNII. fdadrug:hasFirm links establishments to FEI firm nodes in fda-compliance-kg. FAERS reports in fda-drug-event-kg point at the application and package NDC IRIs defined here. Drug recalls live in fda-compliance-kg and link back here through the same UNII and application IRIs.
Source and license. openFDA (drug/drugsfda, drug/ndc, drug/orangebook, drug/label, drug/shortages, other/nsde, transparency/crl), the Drugs@FDA data files, the Orange Book data files, the Purple Book monthly downloads, DECRS, the CBER eBER and eHCTERS public queries, the Inactive Ingredient Database, the Drug Master File list, the 503B registered outsourcing facility list, and CBER's vaccine and cellular and gene therapy product lists: public domain U.S. government works. Funded under NSF award 2535091 (Proto-OKN Theme 2: OKN-Fabric) through subaward 5136002. The graph is released under CC0 1.0.
provenance:
- derivedFrom:
label: openFDA drug endpoints (drugsfda, ndc, orangebook, label, shortages) and other/nsde, transparency/crl
uri: https://open.fda.gov/apis/
kind: Database
license:
data:
label: Public Domain
spdx: CC0-1.0
uri: https://open.fda.gov/license/
- derivedFrom:
label: Drugs@FDA data files
uri: https://www.fda.gov/drugs/drug-approvals-and-databases/drugsfda-data-files
kind: Database
license:
data:
label: Public Domain
spdx: CC0-1.0
- derivedFrom:
label: Orange Book data files
uri: https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files
kind: Database
license:
data:
label: Public Domain
spdx: CC0-1.0
- derivedFrom:
label: Purple Book monthly downloads
uri: https://purplebooksearch.fda.gov/downloads
kind: Database
license:
data:
label: Public Domain
spdx: CC0-1.0
- derivedFrom:
label: Drug Establishments Current Registration Site (DECRS) and CBER eBER and eHCTERS establishment registries
uri: https://www.fda.gov/drugs/drug-approvals-and-databases/drug-establishments-current-registration-site
kind: Database
license:
data:
label: Public Domain
spdx: CC0-1.0
- derivedFrom:
label: Inactive Ingredient Database, Drug Master Files list, registered outsourcing facilities, licensed vaccines and approved cellular and gene therapy products
uri: https://www.fda.gov/drugs/drug-approvals-and-databases
kind: Database
license:
data:
label: Public Domain
spdx: CC0-1.0