XELJANZ

Product NDC
63539-029
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tofacitinib
Dosage form
SOLUTION
Route
ORAL
Labeler
U.S. Pharmaceuticals
Application
NDA213082
Marketing category
NDA
Substance
TOFACITINIB CITRATE
Current FDA listing
Yes

Related Records

Packages

Package NDCDescriptionMarketing startMarketing endSampleStatus
63539-029-021 BOTTLE in 1 CARTON (63539-029-02) / 240 mL in 1 BOTTLE (63539-029-01) 2021-02-08NoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
XELJANZU.S. Pharmaceuticals | Pfizer Inc | Viatris Pharmaceuticals LLC | Pfizer Ireland Pharmaceuticals Unlimited Company | Pfizer Manufacturing Deutschland GmbH | Pfizer Asia Manufacturing Pte Ltd | Pharmacia & Upjohn Company LLC2026-03-27HUMAN PRESCRIPTION DRUG LABEL17
XELJANZU.S. Pharmaceuticals | Pfizer Inc | Viatris Pharmaceuticals LLC | Pfizer Ireland Pharmaceuticals Unlimited Company | Pfizer Manufacturing Deutschland GmbH | Pfizer Asia Manufacturing Pte Ltd2025-03-06HUMAN PRESCRIPTION DRUG LABEL13