Active ingredient
Insulin Degludec
10 finished FDA listings contain Insulin Degludec as their only active ingredient; 1 combination products also contain it.
FDA NDC Directory
- Ingredient names as written by FDA
- INSULIN DEGLUDEC
- Dosage forms
- Injection, Solution
- Routes
- Subcutaneous
- Manufacturers / labelers
- 3
- Strengths listed
- 100 u/ml · 200 u/ml
- Brand names in FDA listings
- Tresiba
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 1670007
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| BLA 203314 | NOVO | 2015-09-25 | 10 |
Official labeling on DailyMed
- INSULIN DEGLUDEC INJECTION, SOLUTION [NOVO NORDISK PHARMA, INC.] · version 2 · 2026-06-17
- INSULIN DEGLUDEC INJECTION, SOLUTION [A-S MEDICATION SOLUTIONS] · version 1 · 2024-06-04
- INSULIN DEGLUDEC INJECTION, SOLUTION [A-S MEDICATION SOLUTIONS] · version 1 · 2024-06-03
- TRESIBA (INSULIN DEGLUDEC) INJECTION, SOLUTION [A-S MEDICATION SOLUTIONS] · version 1 · 2024-02-27
- TRESIBA (INSULIN DEGLUDEC) INJECTION, SOLUTION [A-S MEDICATION SOLUTIONS] · version 11 · 2023-12-13
- TRESIBA (INSULIN DEGLUDEC) INJECTION, SOLUTION [NOVO NORDISK] · version 14 · 2022-07-20
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.