glimepiride

FDA Drug Profile — Glimepiride

glimepiride is listed in the FDA National Drug Code directory with 3 NDC codes, marketed under brand name including Glimepiride. Available dosage form: tablet.

Drug Details

Generic Name
glimepiride
Brand Names
Glimepiride
Application Number
ANDA077370
Sponsor
Solco Healthcare U.S., LLC
NDC Codes
3
Dosage Forms
TABLET
Routes
ORAL
Active Ingredients
GLIMEPIRIDE

Indications and Usage

1 INDICATIONS AND USAGE Glimepiride Tablet are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus [see Clinical Studies ( 14.1 ) ]. Limitations of Use Glimepiride should not be used for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis, as it would not be effective in these settings. Glimepiride Tablets are a sulfonylurea indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus ( 1 ). Important Limitations of Use: Not for treating type 1 diabetes mellitus or diabetic ketoacidosis ( 1 ).