{
  "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": "2026-10-05",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "product_ndc": "68788-8376",
      "generic_name": "Zolpidem Tartrate",
      "labeler_name": "Preferred Pharmaceuticals Inc.",
      "dea_schedule": "CIV",
      "brand_name": "Zolpidem Tartrate",
      "active_ingredients": [
        {
          "name": "ZOLPIDEM TARTRATE",
          "strength": "12.5 mg/1"
        }
      ],
      "finished": true,
      "packaging": [
        {
          "package_ndc": "68788-8376-2",
          "description": "28 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68788-8376-2)",
          "marketing_start_date": "20230301",
          "sample": false
        },
        {
          "package_ndc": "68788-8376-3",
          "description": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68788-8376-3)",
          "marketing_start_date": "20230301",
          "sample": false
        },
        {
          "package_ndc": "68788-8376-6",
          "description": "60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68788-8376-6)",
          "marketing_start_date": "20230301",
          "sample": false
        },
        {
          "package_ndc": "68788-8376-9",
          "description": "90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68788-8376-9)",
          "marketing_start_date": "20230301",
          "sample": false
        }
      ],
      "listing_expiration_date": "20261231",
      "openfda": {
        "manufacturer_name": [
          "Preferred Pharmaceuticals Inc."
        ],
        "rxcui": [
          "854880"
        ],
        "spl_set_id": [
          "625fad5b-8817-4773-a2fc-20b662140e6e"
        ],
        "unii": [
          "WY6W63843K"
        ]
      },
      "marketing_category": "ANDA",
      "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE",
      "spl_id": "fa1a688d-f773-4772-bf54-c1aed9ed8db1",
      "product_type": "HUMAN PRESCRIPTION DRUG",
      "route": [
        "ORAL"
      ],
      "marketing_start_date": "20230301",
      "product_id": "68788-8376_fa1a688d-f773-4772-bf54-c1aed9ed8db1",
      "application_number": "ANDA204170",
      "brand_name_base": "Zolpidem Tartrate",
      "pharm_class": [
        "Central Nervous System Depression [PE]",
        "GABA A Receptor Positive Modulators [MoA]",
        "gamma-Aminobutyric Acid A Receptor Positive Modulator [EPC]"
      ]
    }
  ]
}