NDC 63539-501

XELJANZ XR

Tofacitinib

XELJANZ XR is a Oral Tablet, Extended Release in the Human Prescription Drug category. It is labeled and distributed by U.s. Pharmaceuticals. The primary component is Tofacitinib Citrate.

Product ID63539-501_11ae0c37-f8b9-44bf-b4a7-aef76dd348e3
NDC63539-501
Product TypeHuman Prescription Drug
Proprietary NameXELJANZ XR
Generic NameTofacitinib
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2016-03-07
Marketing CategoryNDA / NDA
Application NumberNDA208246
Labeler NameU.S. Pharmaceuticals
Substance NameTOFACITINIB CITRATE
Active Ingredient Strength11 mg/1
Pharm ClassesJanus Kinase Inhibitor [EPC],Janus Kinase Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 63539-501-14

14 TABLET, EXTENDED RELEASE in 1 BOTTLE (63539-501-14)
Marketing Start Date2016-03-07
NDC Exclude FlagN
Sample Package?Y

NDC SPL Data Element Entries

NDC 63539-501-14 [63539050114]

XELJANZ XR TABLET, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA208246
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-03-07

NDC 63539-501-30 [63539050130]

XELJANZ XR TABLET, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA208246
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-03-07

Drug Details

Active Ingredients

IngredientStrength
TOFACITINIB CITRATE11 mg/1

OpenFDA Data

SPL SET ID:68e3d6b2-7838-4d2d-a417-09d919b43e13
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1357547
  • 1357541
  • 1741049
  • 2048566
  • 2048568
  • 1741046
  • Pharmacological Class

    • Janus Kinase Inhibitor [EPC]
    • Janus Kinase Inhibitors [MoA]

    NDC Crossover Matching brand name "XELJANZ XR" or generic name "Tofacitinib"

    NDCBrand NameGeneric Name
    63539-501XELJANZ XRXELJANZ XR
    63539-502XELJANZ XRXELJANZ XR
    0069-0501XELJANZtofacitinib
    0069-0502XELJANZtofacitinib
    0069-1001XELJANZtofacitinib
    0069-1002XELJANZtofacitinib

    Trademark Results [XELJANZ]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    XELJANZ
    XELJANZ
    86126490 4563705 Live/Registered
    Pfizer Inc.
    2013-11-22
    XELJANZ
    XELJANZ
    85678862 not registered Dead/Abandoned
    Pfizer Inc.
    2012-07-17
    XELJANZ
    XELJANZ
    77688128 4099367 Live/Registered
    Pfizer Inc.
    2009-03-11

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