{
  "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": [
    {
      "update_type": "Reverified",
      "initial_posting_date": "11/04/2024",
      "package_ndc": "50633-310-11",
      "generic_name": "Hydroxocobalamin Injection",
      "related_info_link": "https://www.fda.gov/media/185400/download",
      "contact_info": "1 877 377 3784",
      "availability": "Limited Availability",
      "related_info": "Cyanokit is available to order. To address the drug shortage, BTG International Inc (a SERB Pharmaceuticals company) coordinated with the U.S. Food and Drug Administration (FDA) to make the following impacted batches available to U.S. patients during this period of shortage.",
      "openfda": {
        "application_number": [
          "NDA022041"
        ],
        "brand_name": [
          "CYANOKIT"
        ],
        "generic_name": [
          "HYDROXOCOBALAMIN"
        ],
        "manufacturer_name": [
          "BTG INTERNATIONAL INC."
        ],
        "product_ndc": [
          "50633-310"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "HYDROXOCOBALAMIN"
        ],
        "rxcui": [
          "700496",
          "700499"
        ],
        "spl_id": [
          "9955075c-c059-4b63-b387-e98ef13e60dc"
        ],
        "spl_set_id": [
          "d56fcc8d-bd64-46ab-b0c0-2124bd745a6b"
        ],
        "package_ndc": [
          "50633-310-11"
        ],
        "nui": [
          "N0000175429"
        ],
        "pharm_class_epc": [
          "Antidote [EPC]"
        ],
        "unii": [
          "Q40X8H422O"
        ]
      },
      "update_date": "10/01/2026",
      "therapeutic_category": [
        "Other"
      ],
      "dosage_form": "Injection",
      "presentation": "Cyanokit, Injection, 5 g/250mL (NDC 50633-310-11)",
      "company_name": "BTG International Inc.",
      "shortage_reason": "Other",
      "status": "Current"
    }
  ]
}