{
  "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": "2026-10-02",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "product_ndc": "70377-057",
      "generic_name": "Tofacitinib",
      "labeler_name": "Biocon Pharma Inc",
      "brand_name": "Tofacitinib XR",
      "brand_name_suffix": "XR",
      "active_ingredients": [
        {
          "name": "TOFACITINIB CITRATE",
          "strength": "11 mg/1"
        }
      ],
      "finished": true,
      "packaging": [
        {
          "package_ndc": "70377-057-11",
          "description": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (70377-057-11)",
          "marketing_start_date": "20260603",
          "sample": false
        }
      ],
      "listing_expiration_date": "20271231",
      "openfda": {
        "manufacturer_name": [
          "Biocon Pharma Inc"
        ],
        "rxcui": [
          "1741046"
        ],
        "spl_set_id": [
          "f0160e3d-63ea-75fb-4b88-fe3d6a6ce030"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0370377057113"
        ],
        "unii": [
          "O1FF4DIV0D"
        ]
      },
      "marketing_category": "ANDA",
      "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE",
      "spl_id": "abb2bd0f-2de5-6ca1-6f9a-84a65a1c131d",
      "product_type": "HUMAN PRESCRIPTION DRUG",
      "route": [
        "ORAL"
      ],
      "marketing_start_date": "20260603",
      "product_id": "70377-057_abb2bd0f-2de5-6ca1-6f9a-84a65a1c131d",
      "application_number": "ANDA219442",
      "brand_name_base": "Tofacitinib",
      "pharm_class": [
        "Janus Kinase Inhibitor [EPC]",
        "Janus Kinase Inhibitors [MoA]"
      ]
    }
  ]
}