Rx only 

 

60 Tablets 

 

PRINCIPAL DISPLAY PANEL - 7.5 mg / 500 mg Tablet Bottle Label 

 

PRINCIPAL DISPLAY PANEL - 7.5 mg / 1,000 mg Tablet Bottle Label 

 

NDC 0006-5374-03

 

Segluromet™

(ertugliflozin and

metformin HCl) tablets 

 

7.5 mg / 1,000 mg 

 

Dispense the accompanying Medication Guide

to each patient. 

 

Each tablet contains 9.71 mg ertugliflozin L-pyroglutamic

acid (equivalent to 7.5 mg

ertugliflozin) and 1,000 mg

of metformin hydrochloride.

 

Rx only 

 

60 Tablets 

 

PRINCIPAL DISPLAY PANEL - 7.5 mg / 1,000 mg Tablet Bottle Label 

 

INGREDIENTS AND APPEARANCE 

 

SEGLUROMET   

ertugliflozin and metformin hydrochloride tablet, film coated 

 

Product Information 

Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0006-5369 

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 500 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 15mm 

Flavor  Imprint Code 2;5;500 

Contains      

 

Packaging 

 

#

 

Item Code

 

Package Description

 

Marketing Start Date

 

Marketing End Date

1

NDC:0006-5369-03 60 in 1 BOTTLE; Type 0: Not a Combination Product 12/19/2017  

 

2

NDC:0006-5369-06 180 in 1 BOTTLE; Type 0: Not a Combination Product 12/19/2017  

 

3

NDC:0006-5369-07 500 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 NDA209806 12/19/2017  

 

SEGLUROMET