{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-09-29",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "product_ndc": "0078-0681",
      "generic_name": "dabrafenib",
      "labeler_name": "Novartis Pharmaceuticals Corporation",
      "brand_name": "Tafinlar",
      "active_ingredients": [
        {
          "name": "DABRAFENIB MESYLATE",
          "strength": "75 mg/1"
        }
      ],
      "finished": true,
      "packaging": [
        {
          "package_ndc": "0078-0681-66",
          "description": "120 CAPSULE in 1 BOTTLE (0078-0681-66)",
          "marketing_start_date": "20160401",
          "sample": false
        }
      ],
      "listing_expiration_date": "20271231",
      "openfda": {
        "manufacturer_name": [
          "Novartis Pharmaceuticals Corporation"
        ],
        "rxcui": [
          "1424916",
          "1424918",
          "1425228",
          "1425230",
          "2632552",
          "2632556"
        ],
        "spl_set_id": [
          "fee1e6b1-e1a5-4254-9f2e-a70e0f8dbdea"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "B6DC89I63E"
        ]
      },
      "marketing_category": "NDA",
      "dosage_form": "CAPSULE",
      "spl_id": "6c546993-1f7f-409b-b108-60f22e9b948a",
      "product_type": "HUMAN PRESCRIPTION DRUG",
      "route": [
        "ORAL"
      ],
      "marketing_start_date": "20160401",
      "product_id": "0078-0681_6c546993-1f7f-409b-b108-60f22e9b948a",
      "application_number": "NDA202806",
      "brand_name_base": "Tafinlar",
      "pharm_class": [
        "Breast Cancer Resistance Protein Inhibitors [MoA]",
        "Cytochrome P450 2B6 Inducers [MoA]",
        "Cytochrome P450 2C19 Inducers [MoA]",
        "Cytochrome P450 2C8 Inducers [MoA]",
        "Cytochrome P450 2C9 Inducers [MoA]",
        "Cytochrome P450 3A4 Inducers [MoA]",
        "Kinase Inhibitor [EPC]",
        "Organic Anion Transporter 1 Inhibitors [MoA]",
        "Organic Anion Transporter 3 Inhibitors [MoA]",
        "Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA]",
        "Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA]",
        "Protein Kinase Inhibitors [MoA]"
      ]
    }
  ]
}