Active ingredient
Gadobutrol
20 finished FDA listings contain Gadobutrol as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- GADOBUTROL, GADOBUTROL MONOHYDRATE
- Dosage forms
- Injection
- Routes
- Intravenous
- Manufacturers / labelers
- 5
- Strengths listed
- 604.72 mg/ml
- Brand names in FDA listings
- Gadavist
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 84990
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 |
|---|---|---|---|
| NDA 201277 | BAYER HLTHCARE | 2011-03-14 | 3 |
| ANDA 215061 | HENGRUI PHARMA | 2022-11-17 | 1 |
| ANDA 217480 | HAINAN POLY PHARM | 2023-03-15 | 8 |
| ANDA 216081 | HENGRUI PHARMA | 2023-09-08 | 2 |
| ANDA 219287 | VIWIT PHARM | 2026-06-11 | 6 |
Official labeling on DailyMed
- GADOBUTROL INJECTION [VIWIT PHARMACEUTICAL CO., LTD.] · version 2 · 2026-07-27
- GADOBUTROL INJECTION [ZYDUS PHARMACEUTICALS USA INC.] · version 1 · 2026-07-24
- GADAVIST (GADOBUTROL) INJECTION [BAYER HEALTHCARE PHARMACEUTICALS INC.] · version 23 · 2026-05-28
- GADOBUTROL INJECTION [FRESENIUS KABI USA, LLC] · version 4 · 2025-11-19
- GADOBUTROL INJECTION [FRESENIUS KABI USA, LLC] · version 3 · 2025-09-08
- GADOBUTROL INJECTION [SLATE RUN PHARMACEUTICALS, LLC] · version 4 · 2025-04-21
- GADOBUTROL INJECTION [SLATE RUN PHARMACEUTICALS, LLC] · version 1 · 2025-04-21
- GADOBUTROL INJECTION [SLATE RUN PHARMACEUTICALS, LLC] · version 1 · 2025-04-21
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.