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
6353901202
60 TABLET, FILM COATED in 1 BOTTLE (63539-012-02)

Annotations

UNII (FDA Substance ID)

O1FF4DIV0D

TOFACITINIB CITRATE

RxCUI 1358492

Orange Book

N203214

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": "63539-012_184c6caf-b874-4b42-9a0d-30219f3fd2ef",
  "productndc": "63539-012",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "203214",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 5MG BASE",
        "product_no": "001",
        "approval_date": "Nov 6, 2012"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 10MG BASE",
        "product_no": "002",
        "approval_date": "May 30, 2018"
      }
    ],
    "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": "NDA203214",
  "marketing_category": "NDA",
  "nonproprietary_name": "tofacitinib",
  "start_marketing_date": "20121108",
  "active_numerator_strength": "5"
}

Related drugs

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