{
  "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": "2026-10-09",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 12
    }
  },
  "results": [
    {
      "update_type": "Reverified",
      "initial_posting_date": "04/10/2020",
      "package_ndc": "42023-186-20",
      "generic_name": "Dexmedetomidine Hydrochloride Injection",
      "contact_info": "800-828-9393",
      "availability": "Unavailable",
      "related_info": "Estimated recovery: TBD; Please check wholesalers for inventory",
      "openfda": {
        "application_number": [
          "ANDA208266"
        ],
        "brand_name": [
          "DEXMEDETOMIDINE HYDROCHLORIDE"
        ],
        "generic_name": [
          "DEXMEDETOMIDINE HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "Par Health USA, LLC"
        ],
        "product_ndc": [
          "42023-186",
          "42023-146",
          "42023-187"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "DEXMEDETOMIDINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "309710",
          "1718906",
          "1718909"
        ],
        "spl_id": [
          "54174211-6684-4fb9-a605-be12b94e2948"
        ],
        "spl_set_id": [
          "1ee59985-4c1d-48f7-b8f9-5584c2d55e08"
        ],
        "package_ndc": [
          "42023-146-25",
          "42023-186-20",
          "42023-187-10"
        ],
        "unii": [
          "1018WH7F9I"
        ]
      },
      "update_date": "10/02/2026",
      "therapeutic_category": [
        "Anesthesia"
      ],
      "dosage_form": "Injection",
      "presentation": "Dexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 42023-186-20)",
      "company_name": "Par Health, USA LLC",
      "shortage_reason": "Other",
      "status": "Current"
    }
  ]
}