pioglitazone

FDA Drug Profile — Actos

pioglitazone is listed in the FDA National Drug Code directory with 6 NDC codes, marketed under brand name including Actos. Available dosage form: tablet.

Drug Details

Generic Name
pioglitazone
Brand Names
Actos
Application Number
NDA021073
Sponsor
Takeda Pharmaceutical Company Limited
NDC Codes
6
Dosage Forms
TABLET
Routes
ORAL
Active Ingredients
PIOGLITAZONE HYDROCHLORIDE

Indications and Usage

1 INDICATIONS AND USAGE Pioglitazone and metformin hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use Pioglitazone and metformin hydrochloride tablets are not recommended to treat type 1 diabetes mellitus or diabetic ketoacidosis. Pioglitazone and metformin hydrochloride tablets are a combination of pioglitazone, a thiazolidinedione agonist of peroxisome proliferator receptor gamma, and metformin hydrochloride, 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 )