FDA Drug Database Extractor

Six FDA drug data sources in one Actor — Orange Book (patents and exclusivity), the NDC Directory, openFDA adverse events, recalls and labeling, and Drugs@FDA approvals — returned as typed records. Official openFDA endpoints, no API key.

What it does

The FDA publishes drug data across several separate systems, each with its own quirks. This Actor unifies them behind one mode switch:

Mode	Source	What you get
orangeBook	Orange Book	Approved products with patent and exclusivity data
ndcDirectory	NDC Directory	National Drug Code listings, packaging, labeler
openFDA-events	FAERS	Adverse-event reports
openFDA-recalls	Enforcement	Drug recalls and enforcement actions
openFDA-labeling	SPL labeling	Structured product labels
drugsAtFDA	Drugs@FDA	Approval history and application records

Filter any mode by active ingredient, proprietary (brand) name or applicant company.

Features

• Six FDA data sources behind a single input form.
• Filter by active ingredient — generic names like atorvastatin, metformin.
• Filter by brand name — proprietary names as marketed.
• Filter by applicant — pull everything for a manufacturer.
• Patent and exclusivity data via Orange Book, central to generic-entry analysis.
• Adverse events and recalls for safety and pharmacovigilance work.
• Official openFDA API — authoritative, and no API key required.
• Result cap — maxResults keeps runs bounded.

What people use it for

• Generic-entry analysis — see when patents and exclusivity on a reference drug expire.
• Pharmacovigilance — monitor adverse-event reports for a molecule or brand.
• Recall monitoring — schedule runs and get alerted to enforcement actions.
• Competitive intelligence — track a competitor's approvals and portfolio.
• Formulary and procurement research — resolve NDC codes, packaging and labelers.

Which mode answers which question

• "When can a generic launch?" → orangeBook. It carries the patent and exclusivity information that determines generic entry, plus reference-listed-drug flags.
• "What are the safety signals?" → openFDA-events for FAERS adverse-event reports.
• "Has anything been recalled?" → openFDA-recalls.
• "What does the label say?" → openFDA-labeling for structured product labels including indications and warnings.
• "What's the approval history?" → drugsAtFDA.
• "What NDC codes and packaging exist?" → ndcDirectory.

Date formats and marketing status

Some FDA sources return dates as compact YYYYMMDD strings (19910328) rather than ISO dates — that's the source format, passed through unchanged. Watch marketing_status too: DISCONTINUED products remain in the database long after they leave the market, so filter on it when you only want currently marketed drugs.

Input

mode is required and selects the data source. The three filter fields apply across modes; leave them empty for an unfiltered sample.

Field	Type	Default	What it does
mode (required)	string	orangeBook	orangeBook, ndcDirectory, openFDA-events, openFDA-recalls, openFDA-labeling, drugsAtFDA Options: orangeBook, ndcDirectory, openFDA-events, openFDA-recalls, openFDA-labeling, drugsAtFDA.
activeIngredient	array	[]	Generic name(s) of the active ingredient
proprietaryName	array	[]	Proprietary/brand name
applicant	array	[]	Company name filter
maxResults	integer	100	Maximum records to return per run. Range 1–50000.

Input example

{
  "mode": "orangeBook",
  "maxResults": 10
}

Output

Record shape follows the FDA source for the chosen mode, so fields differ between modes. Orange Book records nest a products array containing active ingredients, strengths, brand names and marketing status.

Every dataset record contains: approval_date, product_number, products, mode, source, activeIngredient, proprietaryName, applicant, applicationNumber, applicationType, dosageForm, route, strength, marketingStatus, approvalDate, fetchedAt.

Output example

A real record from a run of this Actor:

{
  "approval_date": "19910328",
  "product_number": "002",
  "products": [
    {
      "active_ingredients": [
        {
          "name": "CEFAZOLIN SODIUM",
          "strength": "EQ 20MG BASE/ML"
        }
      ],
      "brand_name": "ANCEF IN PLASTIC CONTAINER",
      "application_name": "BAXTER HLTHCARE",
      "application_type": "A",
      "application_number": "063002",
      "reference_listed_drug": false,
      "reference_standard": false,
      "marketing_status": "DISCONTINUED"
    }
  ],
  "mode": "orangeBook",
  "source": "orangeBook",
  "activeIngredient": "CEFAZOLIN SODIUM",
  "proprietaryName": "ANCEF IN PLASTIC CONTAINER",
  "applicant": "BAXTER HEALTHCARE CORP",
  "applicationNumber": "063002",
  "applicationType": "A",
  "dosageForm": "INJECTABLE",
  "route": "INJECTION",
  "strength": "EQ 20MG BASE/ML",
  "marketingStatus": "DISCONTINUED",
  "approvalDate": "19910328",
  "fetchedAt": "2026-08-20T02:51:26.081Z"
}

Export the dataset as JSON, CSV, Excel, XML or JSONL from the Console, or pull it programmatically through the Apify API and any of the official clients.

How to use it

1. Click Try for free (or Start if you already have an Apify account).
2. Fill in the input fields described above — the defaults already produce a working run.
3. Press Start and watch the log; results stream into the dataset as they are found.
4. When the run finishes, open the Output/Storage tab and export as JSON, CSV or Excel.

Runs can be scheduled (hourly, daily, weekly) and wired into Slack, Google Sheets, Zapier, Make, webhooks or your own backend through Apify integrations. Everything the Console does is also available over the Apify API.

Pricing

This Actor is billed on Apify's pay-per-event model: a small charge when a run starts, plus a charge for each result written to the dataset. You only pay for records you actually receive — a run that finds nothing costs only the start event. Current rates are always shown on the Pricing tab of this page, and the run log prints your usage as it goes.

Free-plan credits from Apify cover a large amount of light usage, so you can evaluate the Actor before committing to anything.

FAQ

Do I need an openFDA API key?

No. openFDA is free and public. Keys exist only to raise rate limits for very heavy use; this Actor works without one.

What is the Orange Book?

The FDA's list of approved drug products with therapeutic-equivalence evaluations, including patent and exclusivity data. It's the primary reference for when generic competition can begin.

Can I use adverse-event data to conclude a drug caused harm?

No. FAERS reports are voluntary, unverified and lack a denominator — a report is not proof of causation, and volume tracks prescribing and publicity as much as risk. It's a signal-detection tool, and the FDA says so explicitly.

Why do fields differ between modes?

Each mode maps to a different FDA system with its own schema. The Actor preserves the source structure rather than flattening everything into a lowest-common-denominator shape that would lose information.

Are discontinued drugs included?

Yes — historical records remain. Check marketing_status to restrict to currently marketed products.

Is this suitable for clinical decisions?

No. It's a research and business-intelligence tool. Clinical decisions must rely on current prescribing information and professional judgement.

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Legal and responsible use

This Actor collects only publicly available information. You are responsible for how you use the data, including compliance with the target site's Terms of Service, robots directives, copyright, and data protection law such as GDPR and CCPA. Do not use it to gather personal data without a lawful basis.

Support and feedback

Found a bug, hit a site change, or need an extra field? Open a ticket on the Issues tab of this Actor — issues are read and fixed. Feature requests and custom-scraper enquiries are welcome through the same channel.