;
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
CARNAUBA WAX (UNII: R12CBM0EIZ)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
Product Characteristics
Color BROWN (BEIGE) Score no score
Shape OVAL (ALMOND-SHAPED) Size 12mm
Flavor Imprint Code 554
Contains
Packaging
Item Code
Package Description
Marketing Start Date
Marketing End Date
1NDC:0006-5367-03 30 in 1 BOTTLE; Type 0: Not a Combination Product 12/19/2017
2NDC:0006-5367-06 90 in 1 BOTTLE; Type 0: Not a Combination Product 12/19/2017
3NDC:0006-5367-07 500 in 1 BOTTLE; Type 0: Not a Combination Product 12/19/2017
4NDC:0006-5367-09 2 in 1 CARTON 12/19/2017
4NDC:0006-5367-08 7 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing Category
Application Number or Monograph Citation
Marketing Start Date
Marketing End Date
NDA NDA209805 12/19/2017
STEGLUJAN
ertugliflozin and sitagliptin tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0006-5368
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name
Basis of Strength
Strength
ERTUGLIFLOZIN PIDOLATE (UNII: MLU731K321) (ERTUGLIFLOZIN - UNII:6C282481IP) ERTUGLIFLOZIN 15 mg
SITAGLIPTIN PHOSPHATE (UNII: TS63EW8X6F) (SITAGLIPTIN - UNII:QFP0P1DV7Z) SITAGLIPTIN 100 mg
Inactive Ingredients
Ingredient Name
Strength
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)
MAGNESIUM STEARATE (UNII: 70097M6I30)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
CARNAUBA WAX (UNII: R12CBM0EIZ)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
Product Characteristics
Color BROWN Score no score
Shape OVAL (ALMOND-SHAPED) Size 12mm
Flavor Imprint Code 555
Contains
Packaging
Item Code
Package Description
Marketing Start Date
Marketing End Date
1NDC:0006-5368-03 30 in 1 BOTTLE; Type 0: Not a Combination Product 12/19/2017
2NDC:0006-5368-06 90 in 1 BOTTLE; Type 0: Not a Combination Product 12/19/2017
3NDC:0006-5368-07 500 in 1 BOTTLE; Type 0: Not a Combination Product 12/19/2017
4NDC:0006-5368-09 2 in 1 CARTON 12/19/2017
4NDC:0006-5368-08 7 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing Category
Application Number or Monograph Citation
