FDA Purple Book

FDA Purple Book public records — biologics and biosimilars, license type and dosage.

Public regulatory/health data — not medical advice.

📊 Sample Output

applicant	blaNumber	proprietaryName	properName	licenseType	strength
Pfizer Inc.	761118	Abrilada	adalimumab-afzb	351(k) Interchangeable	40MG/0.8ML
Pfizer Inc.	761118	Abrilada	adalimumab-afzb	351(k) Interchangeable	40MG/0.8ML
Pfizer Inc.	761118	Abrilada	adalimumab-afzb	351(k) Interchangeable	20MG/0.4ML
Pfizer Inc.	761118	Abrilada	adalimumab-afzb	351(k) Interchangeable	10MG/0.2ML
Pfizer Inc.	761118	Abrilada	adalimumab-afzb	351(k) Interchangeable	40MG/0.8ML
Amgen Inc.	761024	Amjevita	adalimumab-atto	351(k) Interchangeable	20MG/0.4ML

Real rows from run hy2HHnXVlhfbYPNqC on build 0.0.17 (2026-09-25), unedited apart from masked emails/phones and shortened long text; fields the source does not publish are empty.

⚙️ Sample inputs

This is the Store example input — the same input Apify's automated check runs — so it is proven to return rows on the current build. Paste it into the input form, or send it through the API, CLI or a schedule:

{
  "properName": "adalimumab"
}

🔧 Input reference

Field	Type	Default	What it does
properName	string	"adalimumab"	Active substance / nonproprietary name, contains match (e.g. 'adalimumab').
proprietaryName	string		Brand name, contains match (e.g. 'Humira', 'Hadlima').
applicant	string		Sponsoring company, contains match.
blaNumber	string		Exact Biologics License Application number.
referenceProduct	string		Find biosimilars of this reference biologic (matches reference proper/brand name).
licenseType	array of string		351(a) = reference biologic; 351(k) Biosimilar; 351(k) Interchangeable.
onlyBiosimilars	boolean	false	Return only 351(k) products (biosimilars and interchangeables).
exclusivityExpiringAfter	string		Keep products whose exclusivity expires on/after this date (YYYY-MM-DD).
exclusivityExpiringBefore	string		Keep products whose exclusivity expires on/before this date (YYYY-MM-DD). Useful for near-term biosimilar opportunities.
maxResults	integer	3000	Maximum number of product records to return.

🧾 JSON sample record

One real record from run hy2HHnXVlhfbYPNqC (emails/phones masked, long text shortened):

{
  "applicant": "Pfizer Inc.",
  "blaNumber": "761118",
  "proprietaryName": "Abrilada",
  "properName": "adalimumab-afzb",
  "licenseType": "351(k) Interchangeable",
  "strength": "40MG/0.8ML",
  "dosageForm": "Injection",
  "routeOfAdministration": "Subcutaneous",
  "productPresentation": "Autoinjector",
  "marketingStatus": "Rx",
  "licensure": "Licensed",
  "approvalDate": "15-Nov-19",
  "interchangeableApprovalDate": "4-Oct-23",
  "referenceProductProperName": "adalimumab",
  "referenceProductProprietaryName": "Humira",
  "supplementNumber": "",
  "submissionType": "Original",
  "interchangeableSupplementNumber": "7",
  "licenseNumber": "2001",
  "productNumber": "001",
  "center": "CDER",
  "dateOfFirstLicensure": "",
  "firstInterchangeableExclusivityExpDate": "",
  "referenceProductExclusivityExpDate": "",
  "orphanExclusivityExpDate": "",
  "patentListProvided": "",
  "isBiosimilar": true,
  "isInterchangeable": true,
  "isReferenceProduct": false,
  "referenceProduct": "adalimumab",
  "sourceFile": "https://www.accessdata.fda.gov/drugsatfda_docs/PurpleBook/2026/purplebook-search-August-data-download.csv"
}

💰 Pricing

Event	Price (USD)	When it is charged
Actor Start (apify-actor-start)	$5e-05	Charged when the Actor starts running. Number of events charged depends on Actor memory (one event per GB, minimum one event).
Biologic record (apify-default-dataset-item)	$0.1	Single result in the default dataset.

Pay-per-event: you pay only for what the run delivers. A run that delivers nothing bills no result events (only the actor-start event, when the actor defines one). Example: a run that delivers 100 results costs 100 × $0.1 = $10.00 plus the start fee.

🔗 Related Actors

More from the NexGenData Healthcare & FDA family:

• FDA Drug Shortages Monitor — Current & Resolved API
• FDA Orange Book — Drug Patent & Exclusivity API
• FDA Pharma Pipeline Tracker — Milestone Data API
• FDA Recall Monitor — Drug & Device Safety Alerts
• FDA Warning Letters & 483 Inspections API
• Medical Device Records — FDA 510(k) & PMA API

15 more in this family on the NexGenData Store page.

📊 What you get

Clean JSON, one record per record (full output has 31 fields):

• applicant — Applicant
• blaNumber — Bla Number
• proprietaryName — Proprietary Name
• properName — Proper Name
• licenseType — License Type
• strength — Strength
• dosageForm — Dosage Form
• routeOfAdministration — Route Of Administration
• productPresentation — Product Presentation
• marketingStatus — Marketing Status

Date columns that are often empty, and why: FDA fills most exclusivity and licensure dates only for the products they apply to. In FDA's September 2026 file, dateOfFirstLicensure was set on 40 of 2,272 products, referenceProductExclusivityExpDate on 36, firstInterchangeableExclusivityExpDate on interchangeable biosimilars only (for example Cyltezo, Hyrimoz, Simlandi), and orphanExclusivityExpDate on about 1 in 4. FDA's own "Exclusivity Expiration Date" column was empty on every product, so it is not output. The exclusivityExpiringBefore / exclusivityExpiringAfter filters use the reference-product exclusivity date, so they only match products where FDA lists one.

Pricing: $0.100 per record (Pay-Per-Event) — about 10 records per $1.

🤖 Use with AI agents

Point Claude, the OpenAI Agents SDK, an n8n flow or any MCP-aware client at it and pull official records on demand.

Sample agent prompt:

List FDA-licensed biosimilars of Humira with license type and approval date.

Agentic payments (x402): Supports agentic payment via x402 — agents can call this actor with USDC, no API key required.

🔗 Related regulatory actors

FDA & public-health records family:

OpenFDA Drug · Drug Approvals · Drug Shortages · Warning Letters/483 · Pharma Pipeline · Adverse Events · Medical Devices

Product-safety recalls: NHTSA Recalls · NHTSA Defects · NHTSA Safety · CPSC Recalls

Agent front door — Healthcare & FDA MCP: Healthcare & FDA MCP

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Public official records and enforcement data, assembled for research and monitoring.