Quick answers
- What is Insulin degludec used for?
- The FDA-approved label (Tresiba, A-S Medication Solutions, February 22, 2024) says: “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. Limitations of Use: • Not recommended for the treatment of diabetic ketoacidosis.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Insulin degludec have a boxed warning?
- No. None of the 6 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Insulin degludec?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Insulin degludec been recalled?
- FDA enforcement reports list 3 recalls of products of this medicine; the newest started March 22, 2021 (Class I). A recall usually concerns specific lots, not every product.
- Who makes Insulin degludec?
- 3 companies list prescription products of Insulin degludec in the FDA NDC Directory, including A-S Medication Solutions, Novo Nordisk and Novo Nordisk Pharma, Inc..
What Insulin degludec is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
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. Limitations of Use: • Not recommended for the treatment of diabetic ketoacidosis.
— FDA label: Tresiba, A-S Medication Solutions, effective February 22, 2024. Read the full label on DailyMed →
The FDA has 6 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 6 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection, solution |
|---|---|
| Route | Subcutaneous |
| Prescription products | 10 in the FDA NDC Directory |
| Brand names | Tresiba |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| insulin degludec 100 units/mL injection, solution | Generic | $11.34–$11.39 per mL 2 packages, lowest to highest |
| insulin degludec 100 units/mL injection, solution | Brand: Tresiba | $9.02–$9.03 per mL 2 packages, lowest to highest |
| insulin degludec 200 units/mL injection, solution | Generic | $22.74 per mL |
| insulin degludec 200 units/mL injection, solution | Brand: Tresiba | $18.06 per mL |
NADAC list of November 4, 2026; these prices took effect between May 20, 2026 and October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- A-S Medication Solutions4 products
- Novo Nordisk3 products
- Novo Nordisk Pharma, Inc.3 products
FDA approval history
- BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| BLA203314 TRESIBA | Novo | September 25, 2015 | 10, latest July 1, 2022 2022: Labeling · 2022: Efficacy · 2019: Labeling |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
March 22, 2021 · Class I · Terminated · D-0620-2021
Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors.
TRESIBA (insulin degludec injection) 100 units/mL (U-100), One 10 mL multi-dose vial, Sample. Not for Resale, Rx only, Manufactured by: Novo Nordisk A/S, Bagsvaerd, Denmark, NDC 0169-2662-90 — Novo Nordisk Inc
-
March 22, 2021 · Class I · Terminated · D-0619-2021
Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors.
TRESIBA FlexTouch (insulin degludec injection) 100 units/mL (U-100), 3 mL Prefilled Pen, Sample, Rx only, Manufactured by: Novo Nordisk A/S, Bagsvaerd, Denmark, Distributed by: Movo Mordisk Inc., Plainsboro, NJ 08536, ND — Novo Nordisk Inc
-
March 22, 2021 · Class I · Terminated · D-0621-2021
Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors.
TRESIBA FlexTouch (insulin degludec injection) 200 units/mL (U-200), 3 mL Prefilled Pen, Sample, Rx only, Manufactured by: Novo Nordisk A/S, Bagsvaerd, Denmark, Distributed by: Novo Nordisk Inc, Plainsboro, NJ 08536, NDC — Novo Nordisk Inc
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Tresiba, A-S Medication Solutions, effective February 22, 2024; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →