ERISTICS
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 Marketing End Date
1 NDC:0006-0112-28 100 in 1 CARTON 10/16/2006
1 NDC:0006-0112-01 1 in 1 BLISTER PACK; Type 0: Not a Combination Product
2 NDC:0006-0112-31 30 in 1 BOTTLE; Type 0: Not a Combination Product 10/16/2006
3 NDC:0006-0112-54 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:0006-0277
Route of Administration ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
Ingredient Name Basis of Strength Strength
SITAGLIPTIN PHOSPHATE (UNII: TS63EW8X6F) (SITAGLIPTIN - UNII:QFP0P1DV7Z) SITAGLIPTIN 100 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 BROWN (beige) Score no score
Shape ROUND (round) Size 10mm
Flavor Imprint Code 277
Contains
PACKAGING
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0006-0277-28 100 in 1 CARTON 10/16/2006
1 NDC:0006-0277-01 1 in 1 BLISTER PACK; Type 0: Not a Combination Product
2 NDC:0006-0277-31 30 in 1 BOTTLE; Type 0: Not a Combination Product 10/16/2006
3 NDC:0006-0277-54 90 in 1 BOTTLE; Type 0: Not a Combination Product 10/16/2006
4 NDC:0006-0277-02 30 in 1 DOSE PACK; Type 0: Not a Combination Product 10/16/2006
5 NDC:0006-0277-33 30 in 1 DOSE PACK; Type 0: Not a Combination Product 10/16/2006
6 NDC:0006-0277-82 1000 in 1 BOTTLE; Type 0: Not a Combination Product 10/16/2006
7 NDC:0006-0277-14 2 in 1 CARTON 10/12/2012
7 7 in 1 BLISTER PACK; Type 0: Not a Combination Product
8 NDC:0006-0277-27 4 in 1 CARTON 10/16/2006 09/30/2015
8 7 in 1 BLISTER PACK; Type 0: Not a Combination Product
9 NDC:0006-0277-30 30 in 1 BOTTLE; Type 0: Not a Combination Produ |
