{
  "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": 19
    }
  },
  "results": [
    {
      "update_type": "Reverified",
      "initial_posting_date": "12/20/2023",
      "package_ndc": "0641-6028-25",
      "generic_name": "Fentanyl Citrate Injection",
      "contact_info": "800-631-2174",
      "availability": "Available",
      "related_info": "Additional lots will be scheduled for manufacturing to meet demand.  Product will be made available as it is released.",
      "openfda": {
        "application_number": [
          "NDA019101"
        ],
        "brand_name": [
          "FENTANYL CITRATE"
        ],
        "generic_name": [
          "FENTANYL CITRATE"
        ],
        "manufacturer_name": [
          "Hikma Pharmaceuticals USA Inc."
        ],
        "product_ndc": [
          "0641-6028",
          "0641-6024",
          "0641-6027",
          "0641-6025",
          "0641-6026",
          "0641-6029",
          "0641-6030",
          "0641-6247",
          "0641-6248",
          "0641-6249"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAMUSCULAR",
          "INTRAVENOUS"
        ],
        "substance_name": [
          "FENTANYL CITRATE"
        ],
        "rxcui": [
          "1735003",
          "1735007",
          "1735008",
          "1735013",
          "2168270",
          "2474269",
          "2629337"
        ],
        "spl_id": [
          "546a047c-1faf-4751-9e48-079e4c35b6fa"
        ],
        "spl_set_id": [
          "ce5db1c2-feb1-4ad2-847a-d02e865bd47e"
        ],
        "package_ndc": [
          "0641-6024-01",
          "0641-6024-10",
          "0641-6027-01",
          "0641-6027-25",
          "0641-6025-01",
          "0641-6025-10",
          "0641-6028-01",
          "0641-6028-10",
          "0641-6028-25",
          "0641-6026-01",
          "0641-6026-05",
          "0641-6029-01",
          "0641-6029-25",
          "0641-6030-01",
          "0641-6247-01",
          "0641-6247-25",
          "0641-6248-01",
          "0641-6248-10",
          "0641-6249-01",
          "0641-6249-10"
        ],
        "unii": [
          "MUN5LYG46H"
        ]
      },
      "update_date": "08/13/2026",
      "therapeutic_category": [
        "Analgesia/Addiction",
        "Pediatric"
      ],
      "dosage_form": "Injection",
      "presentation": "Fentanyl Citrate, Injection, 50 mcg/1 mL (NDC 0641-6028-25)",
      "company_name": "Hikma Pharmaceuticals USA, Inc.",
      "status": "Current"
    }
  ]
}