Active ingredient
Gadopiclenol
14 finished FDA listings contain Gadopiclenol as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- GADOPICLENOL
- Dosage forms
- Injection
- Routes
- Intravenous
- Manufacturers / labelers
- 2
- Strengths listed
- 485.1 mg/ml
- Brand names in FDA listings
- Elucirem, Vueway
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 2618720
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 216986 | GUERBET | 2022-09-21 | 14 |
Official labeling on DailyMed
- VUEWAY (GADOPICLENOL) INJECTION [BRACCO DIAGNOSTICS INC] · version 9 · 2026-04-06
- ELUCIREM (GADOPICLENOL) INJECTION [GUERBET LLC] · version 13 · 2026-03-12
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.