tofacitinib

Orange BookUNIISPLATC L04AF01

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerZydus Pharmaceuticals USA Inc.

CountryUS (United States)

ATC codeL04AF01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
7071012436
60 TABLET, FILM COATED in 1 BOTTLE (70710-1243-6)
ndc11
7071012438
180 TABLET, FILM COATED in 1 BOTTLE (70710-1243-8)

Annotations

UNII (FDA Substance ID)

O1FF4DIV0D

TOFACITINIB CITRATE

RxCUI 1358492

Orange Book

A209829

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "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": "70710-1243_ac4bee46-e55b-46c7-a365-0cc6147f0b79",
  "productndc": "70710-1243",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "209829",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 5MG BASE",
        "product_no": "001",
        "approval_date": "Mar 13, 2023"
      }
    ],
    "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": "ANDA209829",
  "marketing_category": "ANDA",
  "nonproprietary_name": "tofacitinib",
  "start_marketing_date": "20260511",
  "active_numerator_strength": "5"
}

Related drugs

Other records sharing ATC code L04AF01.

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