Active ingredient
Edaravone
5 finished FDA listings contain Edaravone as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- EDARAVONE
- Dosage forms
- Injection, Injection, Solution
- Routes
- Intravenous
- Manufacturers / labelers
- 4
- Strengths listed
- 30 mg/100ml · 60 mg/100ml
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 1921877
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 |
|---|---|---|---|
| ANDA 216199 | GLAND | 2024-05-06 | 3 |
| ANDA 217565 | PHARMOBEDIENT | 2024-10-31 | 1 |
| ANDA 216902 | SANDOZ | 2024-12-23 | 1 |
Official labeling on DailyMed
- EDARAVONE INJECTION, SOLUTION [XGEN PHARMACEUTICALS DJB, INC.] · version 4 · 2026-05-29
- EDARAVONE INJECTION, SOLUTION [PIRAMAL CRITICAL CARE INC.] · version 3 · 2025-11-17
- EDARAVONE INJECTION [SANDOZ INC] · version 1 · 2025-01-21
- EDARAVONE INJECTION, SOLUTION [GLAND PHARMA LIMITED] · version 4 · 2024-05-09
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.