L - 100 MG TABLET BOTTLE LABEL
NDC 0006-0277-31
Januvia®
(sitagliptin) tablets
100 mg
Dispense the accompanying Medication
Guide to each patient.
Each tablet contains 128.5 mg
sitagliptin phosphate, equivalent
to 100 mg sitagliptin.
Rx only
30 Tablets
PRINCIPAL DISPLAY PANEL - 100 mg Tablet Bottle Label
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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
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)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYVINYL ALCOHOL, UNSPECIFIED (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
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)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYVINYL ALCOHOL, UNSPECIFIED (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 CHARACT |
