pioglitazone and metformin hydrochloride

FDA Drug Profile — Actoplus Met

pioglitazone and metformin hydrochloride is listed in the FDA National Drug Code directory with 1 NDC code, marketed under brand name including Actoplus Met. Available dosage form: tablet, film coated.

Drug Details

Generic Name
pioglitazone and metformin hydrochloride
Brand Names
Actoplus Met
Application Number
NDA021842
Sponsor
Takeda Pharmaceuticals America, Inc.
NDC Codes
1
Dosage Forms
TABLET, FILM COATED
Routes
ORAL
Active Ingredients
PIOGLITAZONE HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

Indications and Usage

1 INDICATIONS AND USAGE ACTOPLUS MET is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use ACTOPLUS MET is not recommended to treat type 1 diabetes mellitus or diabetic ketoacidosis. ACTOPLUS MET is a combination of pioglitazone, a thiazolidinedione agonist of peroxisome proliferator receptor gamma, and metformin hydrochloride (HCl), 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 : Not recommended for treatment of type 1 diabetes or diabetic ketoacidosis. ( 1 )