JANUVIA (Page 7 of 7)

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JANUVIA sitagliptin tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:58118-0277(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
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS
croscarmellose sodium
magnesium stearate
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOLS
polyvinyl alcohol
FERRIC OXIDE RED
SODIUM STEARYL FUMARATE
talc
titanium dioxide
FERRIC OXIDE YELLOW
Product Characteristics
Color BROWN (beige) Score no score
Shape ROUND (round) Size 10mm
Flavor Imprint Code 277
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:58118-0277-3 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:58118-0277-6 60 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:58118-0277-9 90 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021995 10/16/2006
Labeler — Clinical Solutions Wholesale (078710347)
Registrant — Clinical Solutions Wholesale (078710347)
Establishment
Name Address ID/FEI Operations
Clinical Solutions Wholesale 078710347 REPACK (58118-0277), RELABEL (58118-0277)

Revised: 12/2013 Clinical Solutions Wholesale

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