Drugs

1Description

Drug labeling and approval data: indications, dosage forms and strengths, contraindications, warnings, interactions, adverse reactions, ingredients, application numbers and approval history. Label sections are split into separate fields and linked to NDC codes, RxCUI, UNII and pharmacologic class. Pharma and health tech teams use it for drug information products, pharmacovigilance and competitive intelligence, and ML teams use it to train clinical NLP models.

Subsets

• Drug labels
• Indications
• Formulations and strengths
• Adverse events
• Approval history
• Drug interactions

2Schema

3Sample records

Sample record

{
  "brand_name": "Jardiance",
  "generic_name": "empagliflozin",
  "manufacturer": "Boehringer Ingelheim Pharmaceuticals, Inc.",
  "application_number": "NDA204629",
  "sponsor": "BOEHRINGER INGELHEIM",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "route": [
    "ORAL"
  ],
  "pharmacologic_class": [
    "Sodium-Glucose Cotransporter 2 Inhibitor [EPC]",
    "Sodium-Glucose Transporter 2 Inhibitors [MoA]"
  ],
  "unii": "HDC1R2M35U",
  "rxcui": [
    "1545658",
    "1545664",
    "1545666",
    "1545668"
  ],
  "product_ndc": [
    "0597-0152",
    "0597-0153"
  ],
  "products": [
    {
      "strength": "10MG",
      "dosage_form": "TABLET",
      "marketing_status": "Prescription",
      "te_code": "AB",
      "reference_listed_drug": true
    },
    {
      "strength": "25MG",
      "dosage_form": "TABLET",
      "marketing_status": "Prescription",
      "te_code": "AB",
      "reference_listed_drug": true
    }
  ],
  "first_approval_date": "2014-08-01",
  "first_approval_type": "Type 1 - New Molecular Entity",
  "approval_history": [
    "2014-08-01: ORIG-1, original approval, standard review",
    "2015-06-26: SUPPL-2, efficacy supplement, standard review",
    "2015-06-26: SUPPL-3, efficacy supplement, standard review",
    "2015-06-26: SUPPL-1, efficacy supplement, standard review",
    "2016-03-18: SUPPL-5, efficacy supplement, standard review",
    "2016-12-02: SUPPL-8, efficacy supplement, standard review",
    "2021-08-18: SUPPL-26, efficacy supplement, standard review",
    "2022-02-24: SUPPL-33, efficacy supplement, priority review",
    "2023-06-20: SUPPL-42, efficacy supplement, priority review",
    "2023-09-21: SUPPL-40, efficacy supplement, standard review"
  ],
  "total_submissions": 26,
  "label_effective_date": "2026-01-30",
  "label_set_id": "faf3dd6a-9cd0-39c2-0d2e-232cb3f67565",
  "indications_and_usage": "JARDIANCE is indicated: to reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure. to reduce the risk of sustained decline in eGFR, end-stage kidney disease, cardiovascular death, and hospitalization in adults with chronic kidney disease at risk of progression. to reduce the risk of cardiovascular death in adults with type 2 diabetes mellitus and established cardiovascular disease. as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older ...",
  "dosage_forms_and_strengths": "JARDIANCE tablets available as: 10 mg pale yellow, round, biconvex and bevel-edged, film-coated tablets debossed with \"S 10\" on one side and the Boehringer Ingelheim company symbol on the other side. 25 mg pale yellow, oval, biconvex, film-coated tablets debossed with \"S 25\" on one side and the Boehringer Ingelheim company symbol on the other side. Tablets: 10 mg, 25 mg",
  "contraindications": "JARDIANCE is contraindicated in patients: with a hypersensitivity to empagliflozin or any of the excipients in JARDIANCE, reactions such as angioedema have occurred. Hypersensitivity to empagliflozin or any of the excipients in JARDIANCE.",
  "warnings_and_precautions": "Diabetic Ketoacidosis in Patients with Type 1 Diabetes Mellitus and Other Ketoacidosis: Consider ketone monitoring in patients with type 1 diabetes mellitus and consider ketone monitoring in others at risk for ketoacidosis, as indicated. Assess for ketoacidosis regardless of presenting blood glucose levels and discontinue JARDIANCE if ketoacidosis ...",
  "drug_interactions": "See Table 4 for clinically relevant interactions with JARDIANCE. Table 4 Clinically Relevant Interactions with JARDIANCE Diuretics Clinical Impact Coadministration of empagliflozin with diuretics resulted in increased urine volume and frequency of voids, which might enhance the potential for volume depletion. Intervention Before initiating JARDIANCE, assess volume status and renal function. In ...",
  "adverse_reactions": "The following important adverse reactions are described below and elsewhere in the labeling: Diabetic Ketoacidosis in Patients with Type 1 Diabetes Mellitus and Other Ketoacidosis Volume Depletion Genitourinary Infections, including Urosepsis, Pyelonephritis, Necrotizing Fasciitis of the Perineum (Fournier's Gangrene), and Genital Mycotic Infections Hypoglycemia Hypersensitivity Reactions Most ...",
  "label_url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=faf3dd6a-9cd0-39c2-0d2e-232cb3f67565",
  "approval_url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=204629"
}

4Uses

• Drug information and clinical decision support products
• Pharmacovigilance and label change monitoring
• Competitive intelligence on approvals and indications
• Training clinical NLP and medical question answering models
• Formulary and drug interaction checking

6Access

The full Drugs dataset (MLC-0402), records on request. Delivered as JSONL, CSV or Parquet under a commercial licence.

Request the full dataset