insulin glargine

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

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

Drug Details

Generic Name
insulin glargine
Brand Names
Lantus, Insulin glargine U-300 Max, LANTUS SOLOSTAR, TOUJEO, Insulin Glargine Solostar, Insulin glargine U-300, Lantus Solostar, TOUJEO Max
Application Number
BLA021081
Sponsor
A-S Medication Solutions
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.