TOFACITINIB

{
  "unii": {
    "unii": "O1FF4DIV0D",
    "rxcui": "1358492",
    "inchikey": "SYIKUFDOYJFGBQ-YLAFAASESA-N",
    "display_name": "TOFACITINIB CITRATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "ac0b26d5-1352-42ff-b5ea-3eb02d8508a4": {
      "match": "brand_token",
      "title": "TOFACITINIB TABLET, FILM COATED, EXTENDED RELEASE [ZYDUS LIFESCIENCES LIMITED]",
      "spl_version": "5",
      "published_date": "2026-05-21"
    }
  },
  "productid": "59651-685_7ce3b2ea-31b1-4429-85c7-90ebf4034c8a",
  "productndc": "59651-685",
  "dosage_form": "TABLET, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "218462",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 11MG BASE",
        "product_no": "001",
        "approval_date": "Jun 3, 2024"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TOFACITINIB CITRATE",
  "proprietary_name": "TOFACITINIB",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA218462",
  "marketing_category": "ANDA",
  "nonproprietary_name": "TOFACITINIB",
  "start_marketing_date": "20260514",
  "active_numerator_strength": "11"
}