alogliptin and metformin hydrochloride

FDA Drug Profile — KAZANO, alogliptin and metformin hydrochloride

alogliptin and metformin hydrochloride is listed in the FDA National Drug Code directory with 13 NDC codes, marketed under brand names including KAZANO, alogliptin and metformin hydrochloride. Available dosage form: tablet, film coated.

Drug Details

Generic Name
alogliptin and metformin hydrochloride
Brand Names
KAZANO, alogliptin and metformin hydrochloride
Application Number
NDA203414
Sponsor
Takeda Pharmaceuticals America, Inc.
NDC Codes
13
Dosage Forms
TABLET, FILM COATED
Routes
ORAL
Active Ingredients
ALOGLIPTIN BENZOATE, METFORMIN HYDROCHLORIDE

Indications and Usage

1 INDICATIONS AND USAGE Alogliptin and metformin HCl tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Alogliptin and metformin HCl tablets are a combination of alogliptin, a dipeptidyl-peptidase-4 (DPP-4) inhibitor and metformin, a biguanide indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. ( 1 ) Limitations of Use: Should not be used in patients with type 1 diabetes mellitus. ( 1 ) Limitations of Use Alogliptin and metformin HCl tablets should not be used in patients with type 1 diabetes mellitus.