NDC 0069-1001

XELJANZ

Tofacitinib

XELJANZ is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Pfizer Laboratories Div Pfizer Inc. The primary component is Tofacitinib Citrate.

Product ID0069-1001_109ebd67-7ce7-4c07-9101-3afd19cefd7b
NDC0069-1001
Product TypeHuman Prescription Drug
Proprietary NameXELJANZ
Generic NameTofacitinib
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2012-11-09
Marketing CategoryNDA / NDA
Application NumberNDA203214
Labeler NamePfizer Laboratories Div Pfizer Inc
Substance NameTOFACITINIB CITRATE
Active Ingredient Strength5 mg/1
Pharm ClassesJanus Kinase Inhibitor [EPC], Janus Kinase Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 0069-1001-01

60 TABLET, FILM COATED in 1 BOTTLE (0069-1001-01)
Marketing Start Date2012-11-09
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0069-1001-02 [00069100102]

XELJANZ TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA203214
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-11-09
Marketing End Date2012-11-09

NDC 0069-1001-03 [00069100103]

XELJANZ TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA203214
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-11-09

NDC 0069-1001-01 [00069100101]

XELJANZ TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA203214
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-11-09

Drug Details

Active Ingredients

IngredientStrength
TOFACITINIB CITRATE5 mg/1

OpenFDA Data

SPL SET ID:cf74ba2f-afc5-4baa-8594-979c889a5831
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1357547
  • 1357541
  • 1741049
  • 2048566
  • 2048568
  • 1741046
  • UPC Code
  • 0300691001011
  • 0300690501307
  • 0300691002018
  • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    0069-0501XELJANZtofacitinib
    0069-0502XELJANZtofacitinib
    0069-1001XELJANZtofacitinib
    0069-1002XELJANZtofacitinib
    63539-012XELJANZXELJANZ
    63539-016XELJANZXELJANZ
    0069-1029XELJANZXELJANZ

    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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