tofacitinib

Orange BookUNIISPLATC L04AF01

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

Identification

ManufacturerZydus Lifesciences Limited

CountryUS (United States)

ATC codeL04AF01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
7077116273
30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (70771-1627-3)
ndc11
7077116279
90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (70771-1627-9)

Annotations

UNII (FDA Substance ID)

O1FF4DIV0D

TOFACITINIB CITRATE

RxCUI 1358492

Orange Book

A214264

ABAB

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": "70771-1627_8997ddda-2a43-45c8-98b0-f1ac03fa3d09",
  "productndc": "70771-1627",
  "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "214264",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 11MG BASE",
        "product_no": "001",
        "approval_date": "Aug 19, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 22MG BASE",
        "product_no": "002",
        "approval_date": "Aug 19, 2021"
      }
    ],
    "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": "ANDA214264",
  "marketing_category": "ANDA",
  "nonproprietary_name": "tofacitinib",
  "start_marketing_date": "20260520",
  "active_numerator_strength": "11"
}

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