{
  "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": "2026-10-07",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "product_ndc": "70436-214",
      "generic_name": "gadobutrol",
      "labeler_name": "Slate Run Pharmaceuticals, LLC",
      "brand_name": "gadobutrol",
      "active_ingredients": [
        {
          "name": "GADOBUTROL",
          "strength": "604.72 mg/mL"
        }
      ],
      "finished": true,
      "packaging": [
        {
          "package_ndc": "70436-214-54",
          "description": "20 VIAL, SINGLE-DOSE in 1 CARTON (70436-214-54)  / 15 mL in 1 VIAL, SINGLE-DOSE (70436-214-34)",
          "marketing_start_date": "20231020",
          "sample": false
        },
        {
          "package_ndc": "70436-214-80",
          "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (70436-214-80)  / 15 mL in 1 VIAL, SINGLE-DOSE (70436-214-34)",
          "marketing_start_date": "20231020",
          "sample": false
        }
      ],
      "listing_expiration_date": "20261231",
      "openfda": {
        "manufacturer_name": [
          "Slate Run Pharmaceuticals, LLC"
        ],
        "spl_set_id": [
          "832e0ae1-4fe1-4dff-9978-c9200bcebb55"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000183362",
          "N0000175862"
        ],
        "pharm_class_epc": [
          "Gadolinium-based Contrast Agent [EPC]"
        ],
        "pharm_class_moa": [
          "Magnetic Resonance Contrast Activity [MoA]"
        ],
        "unii": [
          "1BJ477IO2L"
        ]
      },
      "marketing_category": "ANDA",
      "dosage_form": "INJECTION",
      "spl_id": "3304f07e-e137-e806-e063-6394a90a8a4a",
      "product_type": "HUMAN PRESCRIPTION DRUG",
      "route": [
        "INTRAVENOUS"
      ],
      "marketing_start_date": "20231020",
      "product_id": "70436-214_3304f07e-e137-e806-e063-6394a90a8a4a",
      "application_number": "ANDA217480",
      "brand_name_base": "gadobutrol",
      "pharm_class": [
        "Gadolinium-based Contrast Agent [EPC]",
        "Magnetic Resonance Contrast Activity [MoA]"
      ]
    }
  ]
}