💊 FDA Orange Book Scraper

🚀 Export FDA Orange Book approved drugs with TE codes and ingredients in seconds.

🕒 Last updated: 2026-05-26 · 📊 12 fields per record · 29,000+ products · 200+ TE codes · 12 fields per drug product

The FDA Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) lists every approved prescription, OTC, and biologic product in the United States. This Actor uses the official openFDA Drugs@FDA API to pull one row per product and 12 structured fields covering application, sponsor, ingredient, dosage, route, marketing status, and TE code.

🎯 Target Audience	💡 Primary Use Cases
Pharma teams	Map generics to RLDs
Compliance & legal	Verify TE equivalence claims
Pricing & market access	Build payer formularies
Researchers	Study approval-trend datasets

📋 What the FDA Orange Book Scraper does

• Queries the public FDA Orange Book source and structures the response
• Returns one record per item with 12 normalized fields
• Supports pagination and optional filters
• Outputs to CSV, Excel, JSON, XML via Apify dataset
• Auto-limits to 10 items on the free plan; up to 1,000,000 on paid

💡 Why it matters: FDA Orange Book data is public record. This Actor makes it usable.

🎬 Full Demo (🚧 Coming soon)

⚙️ Input

Field	Type	Description
maxItems	integer	Cap on rows (free: 10)
search	string	Optional openFDA search expression (e.g. sponsor_name:PFIZER)

{ "maxItems": 100 }

{ "maxItems": 500, "search": "sponsor_name:PFIZER" }

⚠️ Good to Know: openFDA refreshes the Orange Book monthly. Some discontinued products retain historical TE codes.

📊 Output

Field	Type	Description
🔹 applicationNumber	string	FDA application number (NDA/ANDA/BLA)
🔹 sponsor	string	Sponsor / applicant company
🔹 brandName	string	Product brand name
🔹 activeIngredient	string	Active ingredient(s) + strength
🔹 dosageForm	string	Dosage form (TABLET, INJECTION...)
🔹 route	string	Route of administration (ORAL, IV...)
🔹 marketingStatus	string	Prescription / OTC / Discontinued
🔹 teCode	string	Therapeutic equivalence code
🔹 referenceDrug	boolean	Whether this is the reference listed drug
🔹 referenceStandard	boolean	Whether this is the reference standard
🔹 latestSubmissionStatus	string	AP, RV, etc.
🔹 latestSubmissionDate	string	YYYYMMDD of latest submission status
🕒 scrapedAt	string	ISO timestamp of when the record was collected
❌ error	string | null	Error message if extraction failed

✨ Why choose this Actor

• Direct FDA Orange Book source, no third-party caching
• Real-time data, never stale
• Pay-per-result pricing; only charged for what you keep
• Works with Make, Zapier, n8n, Airbyte, GitHub Actions, Google Sheets

📈 How it compares to alternatives

Approach	Cost	Maintenance	Coverage
Manual Orange Book PDF download	Free	Medium	Static snapshot
Pharma DBs (IQVIA, Cortellis)	$$$$	None	Curated, paywalled
This actor	Pay per result	None	Live openFDA feed

🚀 How to use

1. Create a free account w/ $5 credit
2. Open the Actor page
3. Set maxItems and any optional filters
4. Run
5. Download dataset as CSV, Excel, JSON, or XML

💼 Business use cases

Competitor & market intelligence

Track FDA Orange Book entries relevant to your sector.

Compliance monitoring

Spot regulatory or enforcement signals in your industry feed.

Lead generation

Use FDA Orange Book entries as a clean prospect list.

Risk & due diligence

Vet counterparties or candidates against the official record.

🔌 Automating FDA Orange Book Scraper

Connects with Make, Zapier, n8n, Slack, Airbyte, GitHub Actions, and Google Drive via Apify's standard integrations.

🌟 Beyond business use cases

Research

Academic studies on regulation, public policy, and enforcement trends.

Personal

Citizens following developments in their communities.

Non-profit

Watchdog organizations and civic-tech projects auditing the record.

Experimentation

Train models on labeled regulatory data.

🤖 Ask an AI assistant about this scraper

ChatGPT, Claude, Perplexity, or Copilot can explain inputs, sample outputs, and integration patterns.

❓ Frequently Asked Questions

Q: What is a TE code? A: A two- or three-letter code rating therapeutic equivalence (AB, BX, etc.). Q: Are biologics included? A: Yes, via BLA application numbers. Q: Can I filter by sponsor? A: Yes via the search input: sponsor_name:PFIZER. Q: Are discontinued products included? A: Yes. Their marketing status reflects that. Q: How fresh is the data? A: openFDA updates the dataset monthly; we pull it live. Q: Is this affiliated with the FDA? A: No. Independent tool using the public openFDA API. Q: How are duplicates handled? A: Each product row is unique by application + product number. Q: What is the reference listed drug? A: The branded innovator a generic is compared against. Q: Can I get patent data? A: Patents are in a separate openFDA endpoint. Q: Are OTCs included? A: Yes. The marketingStatus field will say OTC.

🔌 Integrate with any app

Make, Zapier, n8n, Slack, Airbyte, GitHub Actions, Google Sheets, Webhooks, REST API.

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💡 Pro Tip: browse the complete ParseForge collection.

🆘 Need Help? Open our contact form

⚠️ Disclaimer: independent tool, not affiliated with the FDA Orange Book source agency or any government. Only publicly available data collected.