XELJANZ

Orange BookUNIISPLATC L04AF01

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

Identification

ManufacturerU.S. Pharmaceuticals

CountryUS (United States)

ATC codeL04AF01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6353950230
30 TABLET, EXTENDED RELEASE in 1 BOTTLE (63539-502-30)

Annotations

UNII (FDA Substance ID)

O1FF4DIV0D

TOFACITINIB CITRATE

RxCUI 1358492

Orange Book

N208246

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": {
    "68e3d6b2-7838-4d2d-a417-09d919b43e13": {
      "match": "brand_token",
      "title": "XELJANZ (TOFACITINIB) TABLET, FILM COATED XELJANZ XR (TOFACITINIB) TABLET, EXTENDED RELEASE XELJANZ (TOFACITINIB) SOLUTION [U.S. PHARMACEUTICALS]",
      "spl_version": "17",
      "published_date": "2026-03-30"
    }
  },
  "productid": "63539-502_184c6caf-b874-4b42-9a0d-30219f3fd2ef",
  "productndc": "63539-502",
  "dosage_form": "TABLET, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "208246",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 11MG BASE",
        "product_no": "001",
        "approval_date": "Feb 23, 2016"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 22MG BASE",
        "product_no": "002",
        "approval_date": "Dec 12, 2019"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TOFACITINIB CITRATE",
  "proprietary_name": "XELJANZ",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA208246",
  "marketing_category": "NDA",
  "nonproprietary_name": "tofacitinib",
  "start_marketing_date": "20200121",
  "active_numerator_strength": "22"
}

Related drugs

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