e information, talk to your healthcare provider. You can ask your pharmacist or healthcare provider for information about XELJANZ that is written for health professionals.
What are the ingredients in XELJANZ?
Active ingredient: tofacitinib citrate
Inactive ingredients: microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, magnesium stearate, HPMC 2910/Hypromellose 6cP, titanium dioxide, macrogol/PEG3350, and triacetin.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
LAB-0535-1.0
November 2012
PRINCIPAL DISPLAY PANEL - 60 Tablet Bottle Label
PROFESSIONAL SAMPLE-NOT FOR SALE
ALWAYS DISPENSE WITH MEDICATION GUIDE
Pfizer
NDC 63539-012-02
Xeljanz™
(tofacitinib tablets)
5 mg*
60 Tablets
Rx only
XELJANZ
tofacitinib citrate tablet, film coated
Product Information
Product Type
HUMAN PRESCRIPTION DRUG
Item Code (Source)
NDC:63539-012
Route of Administration
ORAL
DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name
Basis of Strength
Strength
TOFACITINIB CITRATE (TOFACITINIB)
TOFACITINIB
5 mg
Inactive Ingredients
Ingredient Name
Strength
CELLULOSE, MICROCRYSTALLINE
LACTOSE MONOHYDRATE
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
TITANIUM DIOXIDE
TRIACETIN
POLYETHYLENE GLYCOL 3350
HYPROMELLOSE 2910 (6 MPA.S)
Product Characteristics
Color
WHITE (white to off-white)
Score
no score
Shape
ROUND
Size
8mm
Flavor
Imprint Code
PFIZER;JK15
Contains
Packaging
Item Code
Package Description
Multilevel Packaging
1
NDC:63539-012-02
60 TABLET, FILM COATED in 1 BOTTLE
None
Marketing Information
Marketing Category
Application Number or Monograph Citation
Marketing Start Date
Marketing End Date
NDA
NDA203214
11/08/2012
Labeler - U.S. Pharmaceuticals (829076905)
Establishment
Name
Address
ID/FEI
Operations
Pfizer Pharmaceuticals LLC
829084552
LABEL, PACK
Establishment
Name
Address
ID/FEI
Operations
Pfizer Manufacturing Deutschland GmbH (Betriebsstätte Freiburg)
341970073
ANALYSIS, LABEL, MANUFACTURE, PACK
