s 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
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