0P6)
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)
TRIACETIN (UNII: XHX3C3X673)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
Product Characteristics
Color PINK Score no score
Shape TRIANGLE (Triangular, biconvex) Size 7mm
Flavor Imprint Code 701
Contains
Packaging
#
Item Code
Package Description
Marketing Start Date
Marketing End Date
1
NDC:0006-5363-03 30 in 1 BOTTLE; Type 0: Not a Combination Product 12/19/2017
2
NDC:0006-5363-09 2 in 1 CARTON 12/19/2017
2
NDC:0006-5363-08 7 in 1 BOTTLE; Type 0: Not a Combination Product
3
NDC:0006-5363-06 90 in 1 BOTTLE; Type 0: Not a Combination Product 12/19/2017
4
NDC:0006-5363-07 500 in 1 BOTTLE; Type 0: Not a Combination Product 12/19/2017
5
NDC:0006-5363-10 30 in 1 BOTTLE; Type 0: Not a Combination Product 12/19/2017
Marketing Information
Marketing Category
Application Number or Monograph Citation
Marketing Start Date
Marketing End Date
NDA NDA209803 12/19/2017
STEGLATRO
ertugliflozin tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0006-5364
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name
Basis of Strength
Strength
ERTUGLIFLOZIN PIDOLATE (UNII: MLU731K321) (ERTUGLIFLOZIN - UNII:6C282481IP) ERTUGLIFLOZIN 15 mg
Inactive Ingredients
Ingredient Name
Strength
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
MAGNESIUM STEARATE (UNII: 70097M6I30)
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)
TRIACETIN (UNII: XHX3C3X673)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
Product Characteristics
Color RED Score no score
Shape TRIANGLE (Triangular, biconvex) Size 9mm
Flavor Imprint Code 702
Contains
Packaging
#
Item Code
Package Description
Marketing Start Date
Marketing End Date
1
NDC:0006-5364-03 30 in 1 BOTTLE; Type 0: Not a Combination Product 12/19/2017
2
NDC:0006-5364-09 2 in 1 CARTON 12/19/2017
2
NDC:0006-5364-08 7 in 1 BOTTLE; Type 0: Not a Combination Product
3
NDC:0006-5364-06 90 in 1 BOTTLE; Typ
