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
6353902902
1 BOTTLE in 1 CARTON (63539-029-02) / 240 mL in 1 BOTTLE (63539-029-01)

Annotations

UNII (FDA Substance ID)

O1FF4DIV0D

TOFACITINIB CITRATE

RxCUI 1358492

Orange Book

N213082

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": "63539-029_184c6caf-b874-4b42-9a0d-30219f3fd2ef",
  "productndc": "63539-029",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "213082",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 1MG BASE/ML",
        "product_no": "001",
        "approval_date": "Sep 25, 2020"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TOFACITINIB CITRATE",
  "proprietary_name": "XELJANZ",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA213082",
  "marketing_category": "NDA",
  "nonproprietary_name": "tofacitinib",
  "start_marketing_date": "20210208",
  "active_numerator_strength": "1"
}

Related drugs

Other records sharing ATC code L04AF01.

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