{
  "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": "2026-10-06",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "product_ndc": "14445-154",
      "generic_name": "Varenicline tartrate",
      "labeler_name": "Indoco Remedies Limited",
      "brand_name": "Varenicline tartrate",
      "active_ingredients": [
        {
          "name": "VARENICLINE TARTRATE",
          "strength": "1 mg/1"
        }
      ],
      "finished": true,
      "packaging": [
        {
          "package_ndc": "14445-154-02",
          "description": "1 BLISTER PACK in 1 CARTON (14445-154-02)  / 56 TABLET, FILM COATED in 1 BLISTER PACK",
          "marketing_start_date": "20241101",
          "sample": false
        },
        {
          "package_ndc": "14445-154-56",
          "description": "56 TABLET, FILM COATED in 1 BOTTLE (14445-154-56)",
          "marketing_start_date": "20241101",
          "sample": false
        }
      ],
      "listing_expiration_date": "20261231",
      "openfda": {
        "manufacturer_name": [
          "Indoco Remedies Limited"
        ],
        "rxcui": [
          "636671",
          "636676",
          "749289"
        ],
        "spl_set_id": [
          "cd83bc6c-20f4-42e1-adb4-a3d1d89413f4"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0314445155011"
        ],
        "unii": [
          "82269ASB48"
        ]
      },
      "marketing_category": "ANDA",
      "dosage_form": "TABLET, FILM COATED",
      "spl_id": "97b537d2-8829-42ad-86e9-8523b4430843",
      "product_type": "HUMAN PRESCRIPTION DRUG",
      "route": [
        "ORAL"
      ],
      "marketing_start_date": "20241101",
      "product_id": "14445-154_97b537d2-8829-42ad-86e9-8523b4430843",
      "application_number": "ANDA219106",
      "brand_name_base": "Varenicline tartrate",
      "pharm_class": [
        "Cholinergic Agonists [MoA]",
        "Cholinergic Receptor Agonist [EPC]",
        "Partial Cholinergic Nicotinic Agonist [EPC]",
        "Partial Cholinergic Nicotinic Agonists [MoA]"
      ]
    }
  ]
}