{
  "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": "71610-540",
      "generic_name": "Primidone",
      "labeler_name": "Aphena Pharma Solutions - Tennessee, LLC",
      "brand_name": "Primidone",
      "active_ingredients": [
        {
          "name": "PRIMIDONE",
          "strength": "50 mg/1"
        }
      ],
      "finished": true,
      "packaging": [
        {
          "package_ndc": "71610-540-09",
          "description": "9000 TABLET in 1 BOTTLE, PLASTIC (71610-540-09)",
          "marketing_start_date": "20210628",
          "sample": false
        },
        {
          "package_ndc": "71610-540-60",
          "description": "90 TABLET in 1 BOTTLE, PLASTIC (71610-540-60)",
          "marketing_start_date": "20210406",
          "sample": false
        },
        {
          "package_ndc": "71610-540-80",
          "description": "180 TABLET in 1 BOTTLE, PLASTIC (71610-540-80)",
          "marketing_start_date": "20210406",
          "sample": false
        },
        {
          "package_ndc": "71610-540-92",
          "description": "270 TABLET in 1 BOTTLE, PLASTIC (71610-540-92)",
          "marketing_start_date": "20210406",
          "sample": false
        },
        {
          "package_ndc": "71610-540-94",
          "description": "360 TABLET in 1 BOTTLE, PLASTIC (71610-540-94)",
          "marketing_start_date": "20210920",
          "sample": false
        }
      ],
      "listing_expiration_date": "20261231",
      "openfda": {
        "manufacturer_name": [
          "Aphena Pharma Solutions - Tennessee, LLC"
        ],
        "rxcui": [
          "198150"
        ],
        "spl_set_id": [
          "91de277e-34b8-4ee1-8846-f02aea626089"
        ],
        "nui": [
          "N0000175753",
          "N0000008486"
        ],
        "pharm_class_epc": [
          "Anti-epileptic Agent [EPC]"
        ],
        "pharm_class_pe": [
          "Decreased Central Nervous System Disorganized Electrical Activity [PE]"
        ],
        "unii": [
          "13AFD7670Q"
        ]
      },
      "marketing_category": "ANDA",
      "dosage_form": "TABLET",
      "spl_id": "11c79cec-987d-4bce-b8ce-ba3edbe60dc6",
      "product_type": "HUMAN PRESCRIPTION DRUG",
      "route": [
        "ORAL"
      ],
      "marketing_start_date": "20210222",
      "product_id": "71610-540_11c79cec-987d-4bce-b8ce-ba3edbe60dc6",
      "application_number": "ANDA040586",
      "brand_name_base": "Primidone",
      "pharm_class": [
        "Anti-epileptic Agent [EPC]",
        "Decreased Central Nervous System Disorganized Electrical Activity [PE]"
      ]
    }
  ]
}