insulin glargine

FDA Drug Profile — Insulin glargine U-300, Lantus, TOUJEO Max, Insulin glargine U-300 Max, Lantus Solostar

insulin glargine is listed in the FDA National Drug Code directory with 12 NDC codes, marketed under brand names including Insulin glargine U-300, Lantus, TOUJEO Max. Available dosage form: injection, solution.

Drug Details

Generic Name
insulin glargine
Brand Names
Insulin glargine U-300, Lantus, TOUJEO Max, Insulin glargine U-300 Max, Lantus Solostar, LANTUS SOLOSTAR, TOUJEO, Insulin Glargine Solostar
Application Number
BLA206538
Sponsor
Sanofi-Aventis U.S. LLC
NDC Codes
12
Dosage Forms
INJECTION, SOLUTION
Routes
SUBCUTANEOUS
Active Ingredients
INSULIN GLARGINE

Indications and Usage

1 INDICATIONS AND USAGE LANTUS is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. LANTUS is a long-acting human insulin analog indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. ( 1 ) Limitations of Use Not recommended for the treatment of diabetic ketoacidosis. ( 1 ) Limitations of Use LANTUS is not recommended for the treatment of diabetic ketoacidosis.