C3X673)
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)
PRODUCT CHARACTERISTICS
Color WHITE (white to off-white) Score no score
Shape ROUND Size 8mm
Flavor Imprint Code PFIZER;JKI5
Contains
PACKAGING
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0069-1001-01 60 in 1 BOTTLE; Type 0: Not a Combination Product 11/09/2012
2 NDC:0069-1001-02 180 in 1 BOTTLE; Type 0: Not a Combination Product 11/09/2012
3 NDC:0069-1001-03 28 in 1 BOTTLE; Type 0: Not a Combination Product 11/09/2012
MARKETING INFORMATION
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA203214 11/09/2012
XELJANZ XR
tofacitinib tablet, film coated, extended release
PRODUCT INFORMATION
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0069-0501
Route of Administration ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
Ingredient Name Basis of Strength Strength
TOFACITINIB CITRATE (UNII: O1FF4DIV0D) (TOFACITINIB - UNII:87LA6FU830) TOFACITINIB 11 mg
INACTIVE INGREDIENTS
Ingredient Name Strength
SORBITOL (UNII: 506T60A25R)
HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%) (UNII: 8136Y38GY5)
COPOVIDONE K25-31 (UNII: D9C330MD8B)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE ACETATE (UNII: 3J2P07GVB6)
HYDROXYPROPYL CELLULOSE (1200000 MW) (UNII: RFW2ET671P)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)
TRIACETIN (UNII: XHX3C3X673)
FERRIC OXIDE RED (UNII: 1K09F3G675)
SHELLAC (UNII: 46N107B71O)
AMMONIA (UNII: 5138Q19F1X)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
PRODUCT CHARACTERISTICS
Color PINK (pink) Score no score
Shape OVAL Size 8mm
Flavor Imprint Code JKI11
Contains
PACKAGING
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0069-0501-14 14 in 1 BOTTLE; Type 0: Not a Combination Product 03/07/2016
2 NDC:0069-0501-30 30 in 1 BOTTLE; Type 0: Not a Combination Product 03/07/2016
MARKETING INFORMATION
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA208246 03/07/2016
LABELER - PFIZER LABORATORIES DIV PFIZER INC (134489525)
ESTABLISHMENT
Name Address ID/FEI Business Operations
Pfizer Ireland Pharmaceuticals 896090987 ANALYSIS(0069-0501, 0069-1001) , API MANUFACTURE(0069-0501, 0069-1001)
ESTABLISHMENT
Name Address ID/FEI Business Operations
Pfizer Manufacturing Deutschland GmbH (Betriebsstätte Freiburg) 341970073 ANALYSIS(0069-0501, 0069-1001) , API MANUFACTURE(0069-0501, 0069-1001) , LABEL(0069-1001) , |
