{
  "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": "68462-324",
      "generic_name": "ezetimibe and simvastatin",
      "labeler_name": "Glenmark Pharmaceuticals Inc., USA",
      "brand_name": "ezetimibe and simvastatin",
      "active_ingredients": [
        {
          "name": "EZETIMIBE",
          "strength": "10 mg/1"
        },
        {
          "name": "SIMVASTATIN",
          "strength": "80 mg/1"
        }
      ],
      "finished": true,
      "packaging": [
        {
          "package_ndc": "68462-324-05",
          "description": "500 TABLET in 1 BOTTLE (68462-324-05)",
          "marketing_start_date": "20190627",
          "sample": false
        },
        {
          "package_ndc": "68462-324-30",
          "description": "30 TABLET in 1 BOTTLE (68462-324-30)",
          "marketing_start_date": "20190627",
          "sample": false
        },
        {
          "package_ndc": "68462-324-90",
          "description": "90 TABLET in 1 BOTTLE (68462-324-90)",
          "marketing_start_date": "20190627",
          "sample": false
        }
      ],
      "listing_expiration_date": "20261231",
      "openfda": {
        "manufacturer_name": [
          "Glenmark Pharmaceuticals Inc., USA"
        ],
        "rxcui": [
          "476345",
          "476349",
          "476350",
          "476351"
        ],
        "spl_set_id": [
          "32d0e130-1211-44ca-be60-5379ffec96fd"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0368462321300",
          "0368462322307",
          "0368462323304"
        ],
        "nui": [
          "N0000008553",
          "N0000175911",
          "N0000175589",
          "N0000000121"
        ],
        "pharm_class_pe": [
          "Decreased Cholesterol Absorption [PE]"
        ],
        "pharm_class_epc": [
          "Dietary Cholesterol Absorption Inhibitor [EPC]",
          "HMG-CoA Reductase Inhibitor [EPC]"
        ],
        "pharm_class_moa": [
          "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"
        ],
        "unii": [
          "EOR26LQQ24",
          "AGG2FN16EV"
        ]
      },
      "marketing_category": "ANDA",
      "dosage_form": "TABLET",
      "spl_id": "9c80244b-f111-425c-bf4c-c8cc91300cce",
      "product_type": "HUMAN PRESCRIPTION DRUG",
      "route": [
        "ORAL"
      ],
      "marketing_start_date": "20190627",
      "product_id": "68462-324_9c80244b-f111-425c-bf4c-c8cc91300cce",
      "application_number": "ANDA208699",
      "brand_name_base": "ezetimibe and simvastatin",
      "pharm_class": [
        "Decreased Cholesterol Absorption [PE]",
        "Dietary Cholesterol Absorption Inhibitor [EPC]",
        "HMG-CoA Reductase Inhibitor [EPC]",
        "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"
      ]
    }
  ]
}