{
  "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": "68083-111",
      "generic_name": "Labetalol Hydrochloride",
      "labeler_name": "Gland Pharma Limited",
      "brand_name": "Labetalol Hydrochloride",
      "active_ingredients": [
        {
          "name": "LABETALOL HYDROCHLORIDE",
          "strength": "5 mg/mL"
        }
      ],
      "finished": true,
      "packaging": [
        {
          "package_ndc": "68083-111-01",
          "description": "10 VIAL, GLASS in 1 CARTON (68083-111-01)  / 20 mL in 1 VIAL, GLASS",
          "marketing_start_date": "20120419",
          "sample": false
        },
        {
          "package_ndc": "68083-111-02",
          "description": "10 VIAL, GLASS in 1 CARTON (68083-111-02)  / 40 mL in 1 VIAL, GLASS",
          "marketing_start_date": "20120419",
          "sample": false
        }
      ],
      "listing_expiration_date": "20261231",
      "openfda": {
        "manufacturer_name": [
          "Gland Pharma Limited"
        ],
        "rxcui": [
          "896771"
        ],
        "spl_set_id": [
          "48caf986-3126-48e1-afcd-16d65c9cfe00"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "1GEV3BAW9J"
        ]
      },
      "marketing_category": "ANDA",
      "dosage_form": "INJECTION, SOLUTION",
      "spl_id": "f3cca933-34c3-4efd-81c6-02a4920dda16",
      "product_type": "HUMAN PRESCRIPTION DRUG",
      "route": [
        "INTRAVENOUS"
      ],
      "marketing_start_date": "20120419",
      "product_id": "68083-111_f3cca933-34c3-4efd-81c6-02a4920dda16",
      "application_number": "ANDA090699",
      "brand_name_base": "Labetalol Hydrochloride",
      "pharm_class": [
        "Adrenergic beta-Antagonists [MoA]",
        "beta-Adrenergic Blocker [EPC]"
      ]
    }
  ]
}