NDC 63539-502

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 ID63539-502_11ae0c37-f8b9-44bf-b4a7-aef76dd348e3
NDC63539-502
Product TypeHuman Prescription Drug
Proprietary NameXELJANZ XR
Generic NameTofacitinib
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2020-01-21
Marketing CategoryNDA /
Application NumberNDA208246
Labeler NameU.S. Pharmaceuticals
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 63539-502-30

30 TABLET, EXTENDED RELEASE in 1 BOTTLE (63539-502-30)
Marketing Start Date2020-01-21
NDC Exclude FlagN
Sample Package?Y

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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