{
  "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": "2026-08-27",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 4
    }
  },
  "results": [
    {
      "discontinued_date": "06/30/2026",
      "update_type": "New",
      "initial_posting_date": "06/30/2026",
      "package_ndc": "65219-281-02",
      "generic_name": "Gadobutrol Injection",
      "contact_info": "888-386-1300",
      "related_info": "Discontinuance of single dose vials, the other two Imaging Bulk Package(IBP) strengths are to remain in supply: the IBP strengths (18.1416 g/30 mL and 39.3068 g/65 mL); Marketed by Fresenius Kabi, USA",
      "openfda": {
        "application_number": [
          "ANDA215061"
        ],
        "brand_name": [
          "GADOBUTROL"
        ],
        "generic_name": [
          "GADOBUTROL"
        ],
        "manufacturer_name": [
          "Fresenius Kabi USA, LLC"
        ],
        "product_ndc": [
          "65219-281"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "GADOBUTROL"
        ],
        "spl_id": [
          "490c8c3e-3195-40af-8f34-40d8df2719c3"
        ],
        "spl_set_id": [
          "007696d0-4b62-4937-9640-4ad619504df4"
        ],
        "package_ndc": [
          "65219-281-00",
          "65219-281-02",
          "65219-281-03",
          "65219-281-07",
          "65219-281-08",
          "65219-281-10",
          "65219-281-05",
          "65219-281-15"
        ],
        "nui": [
          "N0000183362",
          "N0000175862"
        ],
        "pharm_class_epc": [
          "Gadolinium-based Contrast Agent [EPC]"
        ],
        "pharm_class_moa": [
          "Magnetic Resonance Contrast Activity [MoA]"
        ],
        "unii": [
          "1BJ477IO2L"
        ]
      },
      "update_date": "06/30/2026",
      "therapeutic_category": [
        "Medical Imaging"
      ],
      "dosage_form": "Injection",
      "presentation": "Gadobutrol, Injection, 604.72 mg/mL (NDC 65219-281-02)",
      "company_name": "Jiangsu Hengrui Pharmaceuticals Co., Ltd.",
      "status": "To Be Discontinued"
    }
  ]
}