film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0006-5373
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name
Basis of Strength
Strength
ERTUGLIFLOZIN PIDOLATE (UNII: MLU731K321) (ERTUGLIFLOZIN - UNII:6C282481IP) ERTUGLIFLOZIN 2.5 mg
METFORMIN HYDROCHLORIDE (UNII: 786Z46389E) (METFORMIN - UNII:9100L32L2N) METFORMIN HYDROCHLORIDE 1000 mg
Inactive Ingredients
Ingredient Name
Strength
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
MAGNESIUM STEARATE (UNII: 70097M6I30)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
CARNAUBA WAX (UNII: R12CBM0EIZ)
Product Characteristics
Color PINK Score no score
Shape OVAL Size 19mm
Flavor Imprint Code 2;5;1000
Contains
Packaging
#
Item Code
Package Description
Marketing Start Date
Marketing End Date
1
NDC:0006-5373-03 60 in 1 BOTTLE; Type 0: Not a Combination Product 12/19/2017
2
NDC:0006-5373-06 180 in 1 BOTTLE; Type 0: Not a Combination Product 12/19/2017
3
NDC:0006-5373-07 500 in 1 BOTTLE; Type 0: Not a Combination Product 12/19/2017
4
NDC:0006-5373-09 2 in 1 CARTON 12/19/2017
4
NDC:0006-5373-08 14 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 NDA209806 12/19/2017
SEGLUROMET
ertugliflozin and metformin hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0006-5370
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name
Basis of Strength
Strength
ERTUGLIFLOZIN PIDOLATE (UNII: MLU731K321) (ERTUGLIFLOZIN - UNII:6C282481IP) ERTUGLIFLOZIN 7.5 mg
METFORMIN HYDROCHLORIDE (UNII: 786Z46389E) (METFORMIN - UNII:9100L32L2N) METFORMIN HYDROCHLORIDE 500 mg
Inactive Ingredients
Ingredient Name
Strength
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
