Quick answers
- What is Flumazenil used for?
- The FDA-approved label (Flumazenil, HF Acquisition Co LLC, DBA HealthFirst, July 10, 2026) says: “Adult Patients Flumazenil Injection, USP is indicated for the complete or partial reversal of the sedative effects of benzodiazepines in cases where general anesthesia has been induced and/or maintained with benzodiazepines, where sedation has been produced with benzodiazepines for diagnostic and therapeutic procedures, and for the management of benzodiazepine overdose. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Flumazenil have a boxed warning?
- The label we quote has no boxed warning, but 10 of 18 FDA labels for this medicine do. Check the label of your own product.
- Is there a shortage of Flumazenil?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Flumazenil been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Flumazenil?
- 9 companies list prescription products of Flumazenil in the FDA NDC Directory, including Medical Purchasing Solutions, LLC, Hikma Pharmaceuticals USA Inc. and HF Acquisition Co LLC, DBA HealthFirst.
What Flumazenil is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Adult Patients Flumazenil Injection, USP is indicated for the complete or partial reversal of the sedative effects of benzodiazepines in cases where general anesthesia has been induced and/or maintained with benzodiazepines, where sedation has been produced with benzodiazepines for diagnostic and therapeutic procedures, and for the management of benzodiazepine overdose. …
— FDA label: Flumazenil, HF Acquisition Co LLC, DBA HealthFirst, effective July 10, 2026. Read the full label on DailyMed →
The FDA has 18 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
10 of 18 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection, solution · Injection |
|---|---|
| Route | Intravenous |
| Prescription products | 21 in the FDA NDC Directory |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| flumazenil 0.1 mg/mL injection | Generic | $1.18 per mL |
| flumazenil 0.1 mg/mL injection, solution | Generic | $1.18 per mL |
NADAC list of November 4, 2026; these prices took effect on August 19, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Medical Purchasing Solutions, LLC5 products
- Hikma Pharmaceuticals USA Inc.4 products
- HF Acquisition Co LLC, DBA HealthFirst3 products
- Baxter Healthcare Corporation2 products
- ProPharma Distribution2 products
- Henry Schein, Inc.2 products
- Fresenius Kabi USA, LLC1 product
- HF Acquisition Co. LLC, DBA Health First1 product
- A-S Medication Solutions1 product
FDA approval history
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
Generic approvals (3)
- ANDA076755Baxter Hlthcare Corp · October 12, 2004
- ANDA076955Fresenius Kabi USA · October 12, 2004
- ANDA078527Hikma Farmaceutica · March 23, 2009
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 204508 |
|---|---|
| SPL set ID of the quoted label | 56452ba8-521d-1f84-e063-6294a90af6fc |
| FDA labels (SPL) | 18 |
| FDA applications | 3 ANDA |
| Active ingredients (FDA) | FLUMAZENIL |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Flumazenil, HF Acquisition Co LLC, DBA HealthFirst, effective July 10, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →