{
 "drug": "Gadobutrol Injection",
 "asOf": "2026-08-25",
 "status": "discontinuing",
 "since": "06/30/2026",
 "dayN": 56,
 "cat": "Medical Imaging",
 "companies": [
  "Jiangsu Hengrui Pharmaceuticals Co., Ltd."
 ],
 "reasons": [],
 "records": [
  {
   "discontinued_date": "06/30/2026",
   "update_type": "New",
   "initial_posting_date": "06/30/2026",
   "package_ndc": "65219-281-07",
   "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 65219-281-07)",
   "company_name": "Jiangsu Hengrui Pharmaceuticals Co., Ltd.",
   "status": "To Be Discontinued"
  },
  {
   "discontinued_date": "06/30/2026",
   "update_type": "New",
   "initial_posting_date": "06/30/2026",
   "package_ndc": "65219-281-10",
   "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 65219-281-10)",
   "company_name": "Jiangsu Hengrui Pharmaceuticals Co., Ltd.",
   "status": "To Be Discontinued"
  },
  {
   "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"
  },
  {
   "discontinued_date": "06/30/2026",
   "update_type": "New",
   "initial_posting_date": "06/30/2026",
   "package_ndc": "65219-281-15",
   "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 65219-281-15)",
   "company_name": "Jiangsu Hengrui Pharmaceuticals Co., Ltd.",
   "status": "To Be Discontinued"
  }
 ]
}