Medicine
Bumetanide 1 mg/4 mL injection
Bumetanide 1 mg/4 mL injection is a generic prescription medicine for intramuscular, intravenous use, made by 15 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 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59°…
Key facts
- Active ingredient (INN)
- Bumetanide
- Brand
- Sold under the generic name
- Strength
- 1 mg/4 mL
- Dosage form
- Injection
- Route
- Intramuscular, intravenous
- Packs
- 10 vials of 4 mL, 5 vials of 4 mL, 4 mL and 15 more
- Manufacturers
- Anthea PharmaIndiaCamber PharmaceuticalsIndiaGland PharmaIndiaGlenmark PharmaceuticalsIndiaLupinIndiaNovadoz PharmaceuticalsIndiaCardinal HealthCivicaHikma PharmaceuticalsBryant Ranch Prepack
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59° to 86°F). Protect from light.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- C03CA02 Bumetanide
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 30 April 2008
- Identifiers
- RxCUI 282486, 1727569DailyMed set ID b7cd724b-817b-4b45-8133-1ebf505867e7, 387edfd4-be85-41cd-8a6d-14e6a022b5a9, 680563fe-5d3a-49bc-86a5-740bda2acebe +15NDC 83301-0080, 72205-101, 68462-469 +15Application ANDA219116, ANDA215364, ANDA216434 +5
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 in 1 carton / 4 mL in 1 vial | 83854-007-10 | Anthea PharmaIndia | 27 February 2026 |
| 10 vial, single-dose in 1 carton / 4 mL in 1 vial, single-dose | 31722-368-32 | Camber PharmaceuticalsIndia | 27 February 2025 |
| 10 vial, single-dose in 1 carton / 4 mL in 1 vial, single-dose | 68083-496-10 | Gland PharmaIndia | 26 May 2022 |
| 10 vial, single-dose in 1 carton / 4 mL in 1 vial, single-dose | 68462-469-54 | Glenmark PharmaceuticalsIndia | 1 January 2023 |
| 10 vial in 1 carton / 4 mL in 1 vial | 70748-323-10 | LupinIndia | 11 November 2024 |
| 10 vial in 1 carton / 4 mL in 1 vial | 72205-101-07 | Novadoz PharmaceuticalsIndia | 6 August 2022 |
| 10 vial, single-dose in 1 carton / 4 mL in 1 vial, single-dose | 0641-6008-10 | Hikma Pharmaceuticals | 30 April 2008 |
| 10 vial in 1 carton / 4 mL in 1 vial | 0641-6284-10 | Hikma Pharmaceuticals | 30 April 2008 |
| 10 vial, single-dose in 1 carton / 4 mL in 1 vial, single-dose | 65219-570-04 | Fresenius Kabi | 26 September 2022 |
| 10 vial, single-dose in 1 carton / 4 mL in 1 vial, single-dose | 83301-0080-2 | Mullan Pharmaceutical | 12 August 2025 |
| 10 vial in 1 carton / 4 mL in 1 vial | 67184-0593-2 | Qilu Pharmaceutical | 19 September 2024 |
| 10 vial in 1 carton / 4 mL in 1 vial | 25021-321-04 | Sagent Pharmaceuticals | 1 June 2024 |
| 5 vial in 1 bag / 4 mL in 1 vial | 55154-1527-5 | Cardinal Health | 21 October 2024 |
| 5 vial in 1 bag / 4 mL in 1 vial | 55154-5131-5 | Cardinal Health | 1 July 2026 |
| 10 vial in 1 carton / 4 mL in 1 vial | 72572-040-10 | Civica | 7 March 2022 |
| 10 vial in 1 carton / 4 mL in 1 vial | 72572-210-10 | Civica | 1 August 2026 |
| 10 vial in 1 carton / 4 mL in 1 vial | 72162-2633-2 | Bryant Ranch Prepack | 6 May 2026 |
| 4 mL in 1 vial | 51662-1449-1 | HealthFirst | 11 January 2020 |
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 28 February 1983 | 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 Bumetanide
Clinical summary
Bumetanide is a loop diuretic indicated for the treatment of edema associated with congestive heart failure, hepatic and renal disease, including the nephrotic syndrome. MedsAcross supplies Bumetanide 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 BumetanideFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Bumetanide prescribing information (Edenbridge Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Bumetanide 1 mg/4 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.