Quick answers
- What is Tresiba?
- Tresiba is a brand name of Insulin degludec, a prescription medicine. The FDA NDC Directory lists 5 Tresiba products in 2 strengths and forms.
- Who makes Tresiba?
- Novo holds the FDA application for Tresiba (BLA203314, approved September 25, 2015). 1 other company (repackagers or distributors) also list Tresiba products.
- Is there a generic or store brand of Tresiba?
- Yes. The FDA NDC Directory lists 5 other products with the same active ingredients, strength and form as a Tresiba product. Ask your pharmacist whether one is right for you.
- What do pharmacies pay for Tresiba?
- CMS lists a National Average Drug Acquisition Cost (NADAC) for 2 Tresiba strengths and forms (see the table below). That is what pharmacies pay to buy it, not what you pay: your price depends on your insurance and your pharmacy.
- Has Tresiba been recalled?
- FDA enforcement reports list 3 recalls of Tresiba products; the newest started March 22, 2021. A recall usually concerns specific lots, not every product.
What Tresiba is
Each Tresiba product as listed in the FDA NDC Directory, by active ingredient, strength and form, with its official label. “Same medicine, other names” counts the other products with exactly the same active ingredients, strength and form (generic versions, store brands and other brands); inactive ingredients can differ.
Insulin degludec · prescription medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| insulin degludec 100 units/mL injection, solution (subcutaneous) | Tresiba | 3 products, 2 companies | DailyMed |
| insulin degludec 200 units/mL injection, solution (subcutaneous) | Tresiba | 2 products, 2 companies | DailyMed |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Insulin degludec →
FDA approval
- BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.
| Application | Holder | First approved | Products |
|---|---|---|---|
| BLA203314 | Novo | September 25, 2015 | 5 |
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 | Brand: Tresiba | $9.02–$9.03 per mL 2 packages, lowest to highest Generic of the same strength and form: $11.34–$11.39 per mL |
| insulin degludec 200 units/mL injection, solution | Brand: Tresiba | $18.06 per mL Generic of the same strength and form: $22.74 per mL |
NADAC list of November 4, 2026; these prices took effect on 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 Tresiba
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Tresiba products.
- Novo Nordisk3 products
- A-S Medication Solutions2 products
Recalls
From FDA enforcement reports, matched by the product’s NDC code or label. A recall usually covers specific lots: 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
Sources
- 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 labeling (SPL, 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
- NADAC (National Average Drug Acquisition Cost) 2026 — Centers for Medicare & Medicaid Services (CMS), data.medicaid.gov, list of November 4, 2026, retrieved November 7, 2026
Which names get a brand page: a name the NDC Directory lists for a medicine, held by one company (the FDA application holder, or the company named on most of its products), that is not just a description, and that is not the only product of its medicine.