{
  "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": "0378-1201",
      "generic_name": "Sorafenib",
      "labeler_name": "Mylan Pharmaceuticals Inc.",
      "brand_name": "Sorafenib Tosylate",
      "active_ingredients": [
        {
          "name": "SORAFENIB TOSYLATE",
          "strength": "200 mg/1"
        }
      ],
      "finished": true,
      "packaging": [
        {
          "package_ndc": "0378-1201-78",
          "description": "120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-1201-78)",
          "marketing_start_date": "20220601",
          "sample": false
        }
      ],
      "listing_expiration_date": "20271231",
      "openfda": {
        "manufacturer_name": [
          "Mylan Pharmaceuticals Inc."
        ],
        "rxcui": [
          "597747"
        ],
        "spl_set_id": [
          "b7919013-1511-44f0-a759-3fa78a9fa178"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "5T62Q3B36J"
        ]
      },
      "marketing_category": "ANDA",
      "dosage_form": "TABLET, FILM COATED",
      "spl_id": "40e1cce8-b7c1-4fad-8600-7d7b409bde7e",
      "product_type": "HUMAN PRESCRIPTION DRUG",
      "route": [
        "ORAL"
      ],
      "marketing_start_date": "20220601",
      "product_id": "0378-1201_40e1cce8-b7c1-4fad-8600-7d7b409bde7e",
      "application_number": "ANDA207012",
      "brand_name_base": "Sorafenib Tosylate",
      "pharm_class": [
        "Kinase Inhibitor [EPC]",
        "Protein Kinase Inhibitors [MoA]"
      ]
    }
  ]
}