{
  "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": "2026-09-29",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "product_ndc": "55150-296",
      "generic_name": "Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride",
      "labeler_name": "Eugia US LLC",
      "brand_name": "Dexmedetomidine Hydrochloride",
      "active_ingredients": [
        {
          "name": "DEXMEDETOMIDINE HYDROCHLORIDE",
          "strength": "4 ug/mL"
        }
      ],
      "finished": true,
      "packaging": [
        {
          "package_ndc": "55150-296-10",
          "description": "10 POUCH in 1 CARTON (55150-296-10)  / 1 BAG in 1 POUCH / 50 mL in 1 BAG",
          "marketing_start_date": "20201207",
          "sample": false
        }
      ],
      "listing_expiration_date": "20271231",
      "openfda": {
        "manufacturer_name": [
          "Eugia US LLC"
        ],
        "rxcui": [
          "309710",
          "1718906",
          "1718909"
        ],
        "spl_set_id": [
          "8c162541-986b-4b30-866c-b2631ba2c975"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "1018WH7F9I"
        ]
      },
      "marketing_category": "ANDA",
      "dosage_form": "INJECTION, SOLUTION",
      "spl_id": "a1eab62d-fcef-4b83-9266-3c5f7a05927b",
      "product_type": "HUMAN PRESCRIPTION DRUG",
      "route": [
        "INTRAVENOUS"
      ],
      "marketing_start_date": "20201207",
      "product_id": "55150-296_a1eab62d-fcef-4b83-9266-3c5f7a05927b",
      "application_number": "ANDA210321",
      "brand_name_base": "Dexmedetomidine Hydrochloride",
      "pharm_class": [
        "Adrenergic alpha2-Agonists [MoA]",
        "Central alpha-2 Adrenergic Agonist [EPC]",
        "General Anesthesia [PE]"
      ]
    }
  ]
}