FDA Drug Approvals, Recalls & National Drug Code (NDC) Directory Scraper

Extract official FDA-approved prescription and OTC pharmaceuticals, National Drug Code (NDC) directories, active pharmaceutical ingredients, dosage forms, routes of administration, and real-time FDA Drug Recalls directly from openFDA.

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🎯 Key Features & Capabilities

• National Drug Code (NDC) Directory: Search over 130,000+ FDA-registered pharmaceuticals by proprietary Brand Name, Generic Active Ingredient, or Manufacturer.
• Drug Formulations & Strengths: Captures exact active chemical ingredients, dosage forms (tablets, injections, solutions), route of administration, and package NDC numbers.
• FDA Drug Recall Intelligence: Monitor Class I (life-threatening), Class II, and Class III drug recalls, recalling firms, contaminated lot numbers, and recall reasons.
• High Reliability & Zero Bot Blocking: Direct integration with the official US Food and Drug Administration (FDA) open data API.

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💼 Commercial Use Cases

• Pharmaceutical Wholesalers & Distributors: Verify active NDC registration status, packaging codes, and manufacturer labels before stocking inventory.
• Healthcare Compliance & Hospital Pharmacy Operations: Automate real-time alerts for newly published Class I and Class II drug recall notifications.
• Product Liability & Mass Tort Legal Intelligence: Identify affected patient lot numbers and manufacturer recall histories for medical litigation.
• HealthTech & Telehealth Formularies: Power digital prescription tools, drug databases, and generic substitution recommendations.

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📥 Input Parameters

Parameter	Type	Default	Description
mode	String	"NDC_DIRECTORY"	Mode: NDC_DIRECTORY (Formulations & Approvals) or DRUG_RECALLS (Recalls & Alerts).
brandName	String	"Ozempic"	Trade or brand name (e.g. Lipitor, Ozempic, Keytruda, Advil).
genericName	String	""	Active ingredient (e.g. semaglutide, atorvastatin, ibuprofen).
manufacturer	String	""	Labeler or manufacturer (e.g. Pfizer, Novo Nordisk, Merck).
recallClassification	String	"ALL"	Recalls mode severity: ALL, Class I, Class II, Class III.
maxItems	Integer	25	Maximum number of records to retrieve (1 to 500).

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📤 Output Dataset Format

Mode: NDC Directory

{
  "recordType": "NDC_DRUG_PROFILE",
  "productNdc": "0169-4130",
  "brandName": "Ozempic",
  "brandNameBase": "Ozempic",
  "genericName": "semaglutide",
  "labelerName": "Novo Nordisk",
  "dosageForm": "INJECTION",
  "route": ["SUBCUTANEOUS"],
  "marketingCategory": "NDA",
  "applicationNumber": "NDA209637",
  "listingExpirationDate": "20261231",
  "activeIngredients": [
    {
      "name": "SEMAGLUTIDE",
      "strength": "2 mg/1.5mL"
    }
  ],
  "pharmClass": ["GLP-1 Receptor Agonist [EPC]"],
  "packaging": [
    {
      "packageNdc": "0169-4130-12",
      "description": "1 PEN in 1 CARTON / 1.5 mL in 1 PEN"
    }
  ]
}

Mode: Drug Recalls

{
  "recordType": "FDA_DRUG_RECALL",
  "recallNumber": "D-321-2016",
  "classification": "Class II",
  "status": "Terminated",
  "productDescription": "Progesterone 100 mg/mL in Corn Oil Injection...",
  "reasonForRecall": "Lack of Assurance of Sterility...",
  "recallingFirm": "Essential Wellness Pharmacy",
  "distributionPattern": "Nationwide",
  "recallInitiationDate": "20160415",
  "voluntaryMandated": "Voluntary: Firm Initiated"
}

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🚀 How to Run Locally

cd fda-drug-approvals-scraper
python -m src.main