Active ingredient
Gadoteridol
3 finished FDA listings contain Gadoteridol as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- GADOTERIDOL
- Dosage forms
- Injection, Injection, Solution
- Routes
- Intravenous
- Manufacturers / labelers
- 3
- Strengths listed
- 279.3 mg/ml
- Brand names in FDA listings
- Prohance
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 25483
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 020131 | BRACCO | 1992-11-16 | 1 |
| NDA 021489 | BRACCO | 2003-10-09 | 1 |
| ANDA 218749 | HAINAN POLY | 2025-02-11 | 1 |
Official labeling on DailyMed
- GADOTERIDOL INJECTION [SLATE RUN PHARMACEUTICALS, LLC] · version 2 · 2025-09-29
- PROHANCE (GADOTERIDOL) INJECTION, SOLUTION [BRACCO DIAGNOSTICS INC] · version 24 · 2025-03-21
- PROHANCE (GADOTERIDOL) INJECTION, SOLUTION [BRACCO DIAGNOSTICS INC] · version 28 · 2025-03-21
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.