JANUVIA (Page 7 of 7)

Package/Label Display Panel

Januvia (sitagliptin) tablets

100 mg

1350 Tablets

bottle label
(click image for full-size original)
JANUVIA sitagliptin tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55154-5042(NDC:0006-0277)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SITAGLIPTIN PHOSPHATE (SITAGLIPTIN) SITAGLIPTIN 100 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS DIBASIC CALCIUM PHOSPHATE
CROSCARMELLOSE SODIUM
magnesium stearate
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYVINYL ALCOHOL, UNSPECIFIED
FERRIC OXIDE RED
SODIUM STEARYL FUMARATE
talc
titanium dioxide
FERRIC OXIDE YELLOW
Product Characteristics
Color BROWN (light beige) Score no score
Shape ROUND (round) Size 10mm
Flavor Imprint Code 277
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55154-5042-8 1350 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021995 10/16/2006
Labeler — Cardinal Health 107, LLC (118546603)

Revised: 01/2023 Cardinal Health 107, LLC

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