insulin degludec

FDA Drug Profile — Insulin Degludec, Tresiba, TRESIBA

insulin degludec is listed in the FDA National Drug Code directory with 11 NDC codes, marketed under brand names including Insulin Degludec, Tresiba, TRESIBA. Available dosage form: injection, solution.

Drug Details

Generic Name
insulin degludec
Brand Names
Insulin Degludec, Tresiba, TRESIBA
Application Number
BLA203314
Sponsor
Novo Nordisk Pharma, Inc.
NDC Codes
11
Dosage Forms
INJECTION, SOLUTION
Routes
SUBCUTANEOUS
Active Ingredients
INSULIN DEGLUDEC

Indications and Usage

1 INDICATIONS AND USAGE TRESIBA is indicated to improve glycemic control in patients 1 year of age and older with diabetes mellitus. Limitations of Use • Not recommended for the treatment of diabetic ketoacidosis. TRESIBA is a long-acting human insulin analog indicated to improve glycemic control in patients 1 year of age and older with diabetes mellitus ( 1 ). Limitations of Use: • Not recommended for the treatment of diabetic ketoacidosis.