NDC 63539-501

Xeljanzxr 11 mg tablet, extended release

On the label: U.S. Pharmaceuticals.

Ireland: 2Singapore: 1United States: 1

Where it's made

FactoryWhereRoleLast FDA inspection
Pfizer Asia Manufacturing Pte LtdSingapore, SingaporeMakes the active ingredient and tests it Problems found, fixed voluntarilyOct 18, 2023 · 6 inspections
Pfizer Ireland Pharmaceuticals Unlimited CompanyNewbridge, IrelandMakes it and tests it Problems found, fixed voluntarilySep 23, 2022 · 8 inspections
Pfizer Ireland Pharmaceuticals Unlimited CompanyRingaskiddy, IrelandMakes the active ingredient and tests it Problems found, fixed voluntarilyOct 25, 2024 · 6 inspections
Viatris Pharmaceuticals LLCBarceloneta, PR, United StatesMakes it and tests it No problems foundJun 13, 2025 · 8 inspections, 1 with FDA action
Pfizer Manufacturing Deutschland GmbHFreiburg im Breisgau, GermanyTests it, packages it and labels it Problems found, fixed voluntarilyJul 2, 2025 · 8 inspections
Viatris Pharmaceuticals LLCVega Baja, PR, United StatesTests it, packages it and labels it Problems found, fixed voluntarilyMay 18, 2026 · 11 inspections

Product details

Generic drug
Tofacitinib: every company that makes it
Form
tablet, extended release, oral
Strength
11 mg
Approval
NDA NDA208246
On the market since
Mar 7, 2016
Package NDCs
63539-501-14 63539-501-30
Official label
DailyMed (National Library of Medicine), updated Oct 6, 2026

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