FDA label
What is Tresiba used for?
Tresiba contains insulin degludec. The FDA-approved uses below are quoted from the Indications and Usage section of its DailyMed label.
Source: DailyMed SPL label file dated 2026-10-23. Publisher page
The FDA label says: “TRESIBA is indicated to improve glycemic control in patients 1 year of age and older with diabetes mellitus.”
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Tresiba, injection, solution
Indications and Usage, quoted from the label by Novo Nordisk (BLA203314). Cross-references to other label sections are left out.
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.
Source: DailyMed label, set id 456c5e87-3dfd-46fa-8ac0-c6128d4c97c6, version 14, effective July 1, 2022. NDC 0169-2550, one of 5 listings for this product.
Questions
What is Tresiba used for?
The FDA label says: “TRESIBA is indicated to improve glycemic control in patients 1 year of age and older with diabetes mellitus.”
What drug class is Tresiba?
FDA lists insulin degludec in the Insulin Analog established pharmacologic class.
Does this page cover off-label uses or dosing?
No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.