{
  "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": 27
    }
  },
  "results": [
    {
      "update_type": "Revised",
      "initial_posting_date": "11/01/2017",
      "package_ndc": "0641-6254-01",
      "generic_name": "Hydromorphone Hydrochloride Injection",
      "contact_info": "800-631-2174",
      "availability": "Unavailable",
      "related_info": "Product temporarily on backorder.  Additional lots will be available in the August 2026 timeframe.",
      "openfda": {
        "application_number": [
          "NDA217812"
        ],
        "brand_name": [
          "HYDROMORPHONE HYDROCHLORIDE"
        ],
        "generic_name": [
          "HYDROMORPHONE HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "Hikma Pharmaceuticals USA Inc."
        ],
        "product_ndc": [
          "0641-6254"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAMUSCULAR",
          "INTRAVENOUS",
          "SUBCUTANEOUS"
        ],
        "substance_name": [
          "HYDROMORPHONE HYDROCHLORIDE"
        ],
        "spl_id": [
          "68e84ae8-2bd5-4f57-abef-4d0cde3c4775"
        ],
        "spl_set_id": [
          "c729424e-e483-4bf8-b86c-ce56636dcffa"
        ],
        "package_ndc": [
          "0641-6254-01"
        ],
        "unii": [
          "L960UP2KRW"
        ]
      },
      "update_date": "08/13/2026",
      "therapeutic_category": [
        "Analgesia/Addiction"
      ],
      "dosage_form": "Injection",
      "presentation": "Hydromorphone Hydrochloride, Injection, 2 mg/1 mL (NDC 0641-6254-01)",
      "company_name": "Hikma Pharmaceuticals USA, Inc.",
      "shortage_reason": "Demand increase for the drug",
      "status": "Current"
    }
  ]
}