Active ingredient
Gadoquatrane
11 finished FDA listings contain Gadoquatrane as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- GADOQUATRANE
- Dosage forms
- Injection
- Routes
- Intravenous
- Manufacturers / labelers
- 1
- Strengths listed
- 257.9 mg/ml
- Brand names in FDA listings
- Ambelvist
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 2745120
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 219627 | BAYER HEALTHCARE | 2026-06-12 | 11 |
Official labeling on DailyMed
- AMBELVIST (GADOQUATRANE) INJECTION [BAYER HEALTHCARE PHARMACEUTICALS INC.] · version 5 · 2026-06-15
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.