{
  "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": "2026-09-25",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "product_ndc": "68382-141",
      "generic_name": "topiramate",
      "labeler_name": "Zydus Pharmaceuticals USA Inc.",
      "brand_name": "topiramate",
      "active_ingredients": [
        {
          "name": "TOPIRAMATE",
          "strength": "200 mg/1"
        }
      ],
      "finished": true,
      "packaging": [
        {
          "package_ndc": "68382-141-01",
          "description": "100 TABLET, FILM COATED in 1 BOTTLE (68382-141-01)",
          "marketing_start_date": "20090327",
          "sample": false
        },
        {
          "package_ndc": "68382-141-05",
          "description": "500 TABLET, FILM COATED in 1 BOTTLE (68382-141-05)",
          "marketing_start_date": "20090327",
          "sample": false
        },
        {
          "package_ndc": "68382-141-14",
          "description": "60 TABLET, FILM COATED in 1 BOTTLE (68382-141-14)",
          "marketing_start_date": "20090327",
          "sample": false
        },
        {
          "package_ndc": "68382-141-16",
          "description": "90 TABLET, FILM COATED in 1 BOTTLE (68382-141-16)",
          "marketing_start_date": "20090327",
          "sample": false
        }
      ],
      "listing_expiration_date": "20271231",
      "openfda": {
        "manufacturer_name": [
          "Zydus Pharmaceuticals USA Inc."
        ],
        "rxcui": [
          "151226",
          "199888",
          "199889",
          "199890"
        ],
        "spl_set_id": [
          "67dcdd6e-48bc-418e-a887-805929d83ce0"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0368382140142",
          "0368382141149",
          "0368382139146",
          "0368382138149"
        ],
        "nui": [
          "N0000008486",
          "N0000185506",
          "N0000182140"
        ],
        "pharm_class_pe": [
          "Decreased Central Nervous System Disorganized Electrical Activity [PE]"
        ],
        "pharm_class_moa": [
          "Cytochrome P450 3A4 Inducers [MoA]",
          "Cytochrome P450 2C19 Inhibitors [MoA]"
        ],
        "unii": [
          "0H73WJJ391"
        ]
      },
      "marketing_category": "ANDA",
      "dosage_form": "TABLET, FILM COATED",
      "spl_id": "48ba6ac8-7f36-4a5c-8055-295af6083862",
      "product_type": "HUMAN PRESCRIPTION DRUG",
      "route": [
        "ORAL"
      ],
      "marketing_start_date": "20090327",
      "product_id": "68382-141_48ba6ac8-7f36-4a5c-8055-295af6083862",
      "application_number": "ANDA078235",
      "brand_name_base": "topiramate",
      "pharm_class": [
        "Cytochrome P450 2C19 Inhibitors [MoA]",
        "Cytochrome P450 3A4 Inducers [MoA]",
        "Decreased Central Nervous System Disorganized Electrical Activity [PE]"
      ]
    }
  ]
}