Active ingredient
Flumazenil
21 finished FDA listings contain Flumazenil as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- FLUMAZENIL
- Dosage forms
- Injection, Injection, Solution
- Routes
- Intravenous
- Manufacturers / labelers
- 10
- Strengths listed
- .1 mg/ml
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 4457
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 076755 | BAXTER HLTHCARE CORP | 2004-10-12 | 4 |
| ANDA 076955 | FRESENIUS KABI USA | 2004-10-12 | 4 |
| ANDA 078527 | HIKMA FARMACEUTICA | 2009-03-23 | 13 |
Official labeling on DailyMed
- FLUMAZENIL INJECTION, SOLUTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST] · version 1 · 2026-07-13
- FLUMAZENIL INJECTION, SOLUTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST] · version 3 · 2026-07-03
- FLUMAZENIL INJECTION, SOLUTION [HF ACQUISITION CO. LLC, DBA HEALTHFIRST] · version 9 · 2026-06-22
- FLUMAZENIL INJECTION, SOLUTION [MEDICAL PURCHASING SOLUTIONS, LLC] · version 1 · 2026-06-10
- FLUMAZENIL INJECTION, SOLUTION [PROPHARMA DISTRIBUTION] · version 2 · 2025-12-19
- FLUMAZENIL INJECTION [BAXTER HEALTHCARE CORPORATION] · version 17 · 2025-11-17
- FLUMAZENIL INJECTION, SOLUTION [PROPHARMA DISTRIBUTION] · version 1 · 2025-09-25
- FLUMAZENIL INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] · version 5 · 2025-04-16
- FLUMAZENIL INJECTION, SOLUTION [HENRY SCHEIN, INC.] · version 1 · 2025-02-21
- FLUMAZENIL INJECTION, SOLUTION [HENRY SCHEIN, INC.] · version 1 · 2025-02-21
- FLUMAZENIL INJECTION, SOLUTION [A-S MEDICATION SOLUTIONS] · version 25 · 2025-02-13
- FLUMAZENIL INJECTION [MEDICAL PURCHASING SOLUTIONS, LLC] · version 1 · 2024-12-12
Showing the 12 most recent of 18 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.