Medicine
Flumazenil 0.5 mg/5 mL injection
Flumazenil 0.5 mg/5 mL injection is a generic prescription medicine for intravenous use, made by 8 labelers, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Store at 25ºC (77ºF), excursions permitted to 15º to 30ºC (59º to 86ºF).
Key facts
- Active ingredient (INN)
- Flumazenil
- Brand
- Sold under the generic name
- Strength
- 0.5 mg/5 mL
- Dosage form
- Injection
- Route
- Intravenous
- Packs
- 10 vials of 5 mL, 5 mL, 10 pouches of 5 mL and 10 more
- Manufacturers
- HealthFirstHikma PharmaceuticalsMedical Purchasing SolutionsA-S Medication SolutionsBaxter HealthcareFresenius KabiHenry ScheinProPharma Distribution
- Origin register
- US FDA, United States
- Storage
- Store at 25ºC (77ºF), excursions permitted to 15º to 30ºC (59º to 86ºF).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- V03AB25 Flumazenil
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 5 April 2005
- Identifiers
- RxCUI 204508DailyMed set ID 2190e8d0-d7ca-4f53-b243-0d2c31979aa8, 6673efde-057a-a889-e053-2a91aa0a517b, 1855bb03-392f-4a0d-8361-24fc2a0e635e +9NDC 50090-1337, 71872-7038, 0404-9793 +9Application ANDA078527, ANDA076955, ANDA076755
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
Packs from every labeler of this generic presentation.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 10 vial, multi-dose in 1 box / 5 mL in 1 vial, multi-dose | 0143-9684-10 | Hikma Pharmaceuticals | 23 March 2009 |
| 10 vial, multi-dose in 1 box / 5 mL in 1 vial, multi-dose | 0143-9784-10 | Hikma Pharmaceuticals | 1 January 2007 |
| 10 vial, multi-dose in 1 package / 5 mL in 1 vial, multi-dose | 36000-148-10 | Baxter Healthcare | 1 October 2017 |
| 10 vial, multi-dose in 1 tray / 5 mL in 1 vial, multi-dose | 63323-424-05 | Fresenius Kabi | 5 April 2005 |
| 5 mL in 1 vial, multi-dose | 51662-1254-1 | HealthFirst | 1 September 2018 |
| 10 pouch in 1 case / 1 vial, multi-dose in 1 pouch / 5 mL in 1 vial, multi-dose | 51662-1254-3 | HealthFirst | 1 September 2018 |
| 10 pouch in 1 case / 1 vial, multi-dose in 1 pouch / 5 mL in 1 vial, multi-dose | 51662-1579-3 | HealthFirst | 28 June 2021 |
| 10 pouch in 1 case / 1 vial, multi-dose in 1 pouch / 5 mL in 1 vial, multi-dose | 51662-1699-3 | HealthFirst | 10 July 2026 |
| 1 vial, multi-dose in 1 bag / 5 mL in 1 vial, multi-dose | 71872-7038-1 | Medical Purchasing Solutions | 28 February 2018 |
| 1 vial, multi-dose in 1 bag / 5 mL in 1 vial, multi-dose | 71872-7375-1 | Medical Purchasing Solutions | 8 June 2026 |
| 1 vial, multi-dose in 1 box / 5 mL in 1 vial, multi-dose | 50090-1337-0 | A-S Medication Solutions | 14 December 2018 |
| 1 vial, multi-dose in 1 bag / 5 mL in 1 vial, multi-dose | 0404-9793-05 | Henry Schein | 14 February 2025 |
| 5 mL in 1 vial, multi-dose | 84549-784-10 | ProPharma Distribution | 16 September 2025 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 20 December 1991 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Other strengths and forms of Flumazenil
Clinical summary
Flumazenil is a benzodiazepine antagonist 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, among other approved uses. MedsAcross supplies Flumazenil for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Read about FlumazenilFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Flumazenil prescribing information (Fresenius Kabi) · U.S. National Library of Medicine, DailyMed
Need Flumazenil 0.5 mg/5 mL injection for your hospital or patient?
Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.