NDC 0069-0502

XELJANZ XR

Tofacitinib

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

Product ID0069-0502_51f83e6a-1602-400e-8d61-5958f6a0f978
NDC0069-0502
Product TypeHuman Prescription Drug
Proprietary NameXELJANZ XR
Generic NameTofacitinib
Dosage FormTablet, Film Coated, Extended Release
Route of AdministrationORAL
Marketing Start Date2020-01-21
Marketing CategoryNDA /
Application NumberNDA208246
Labeler NamePfizer Laboratories Div Pfizer Inc
Substance NameTOFACITINIB CITRATE
Active Ingredient Strength22 mg/1
Pharm ClassesJanus Kinase Inhibitor [EPC],Janus Kinase Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 0069-0502-30

30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0069-0502-30)
Marketing Start Date2020-01-21
NDC Exclude FlagN
Sample Package?N

Drug Details

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

NDCBrand NameGeneric Name
0069-0501XELJANZtofacitinib
0069-1001XELJANZtofacitinib
0069-1002XELJANZtofacitinib
63539-012XELJANZtofacitinib
63539-016XELJANZtofacitinib
63539-501XELJANZtofacitinib
0069-0502XELJANZtofacitinib
63539-502XELJANZtofacitinib

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