se the accompanying Medication
Guide to each patient.
Each tablet contains 128.5 mg
sitagliptin phosphate, equivalent
to 100 mg sitagliptin.
Rx only
30 Tablets
Close
INGREDIENTS AND APPEARANCE
JANUVIA
sitagliptin tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0006-0221
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SITAGLIPTIN PHOSPHATE (UNII: TS63EW8X6F) (SITAGLIPTIN - UNII:QFP0P1DV7Z) SITAGLIPTIN 25 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
polyvinyl alcohol (UNII: 532B59J990)
FERRIC OXIDE RED (UNII: 1K09F3G675)
SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)
talc (UNII: 7SEV7J4R1U)
titanium dioxide (UNII: 15FIX9V2JP)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
Product Characteristics
Color PINK (pink) Score no score
Shape ROUND (round) Size 6mm
Flavor Imprint Code 221
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0006-0221-28 100 in 1 CARTON 10/16/2006
1 NDC:0006-0221-01 1 in 1 BLISTER PACK; Type 0: Not a Combination Product
2 NDC:0006-0221-31 30 in 1 BOTTLE; Type 0: Not a Combination Product 10/16/2006
3 NDC:0006-0221-54 90 in 1 BOTTLE; Type 0: Not a Combination Product 10/16/2006
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021995 10/16/2006
JANUVIA
sitagliptin tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0006-0112
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SITAGLIPTIN PHOSPHATE (UNII: TS63EW8X6F) (SITAGLIPTIN - UNII:QFP0P1DV7Z) SITAGLIPTIN 50 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
magnesium stearate (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
polyvinyl alcohol (UNII: 532B59J990)
FERRIC OXIDE RED (UNII: 1K09F3G675)
SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)
talc (UNII: 7SEV7J4R1U)
titanium dioxide (UNII: 15FIX9V2JP)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
Product Characteristics
Color BROWN (light beige) Score no score
Shape ROUND (round) Size 8mm
Flavor Imprint Code 112
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketin |
