Medicine
Magnesium sulfate 4 g/50 mL injection
Magnesium sulfate 4 g/50 mL injection is a generic prescription medicine for intravenous use, made by 5 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
PROTECT FROM FREEZING. Store at 20° to 25°C (68° to 77°F).
Key facts
- Active ingredient (INN)
- Magnesium sulfate
- Brand
- Sold under the generic name
- Strength
- 4 g/50 mL
- Dosage form
- Injection
- Route
- Intravenous
- Packs
- 24 containers of 50 mL, 40 bags of 50 mL, 24 bags of 50 mL and 3 more
- Manufacturers
- AvenacyB. Braun MedicalBaxter HealthcareFresenius KabiWG Critical Care
- Origin register
- US FDA, United States
- Storage
- PROTECT FROM FREEZING. Store at 20° to 25°C (68° to 77°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- A06AD04 Magnesium sulfate
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 15 March 2016
- Identifiers
- RxCUI 829734, 1658259, 1658262 +3DailyMed set ID 752f55bb-c4ca-4545-94b3-3deea66888d4, fef9e18c-5210-4090-b564-4950ebe461c0, f5f6b4c9-4a68-4342-b1e4-f4b61b7fb9cb +2NDC 44567-424, 63323-107, 0264-4205 +2Application ANDA207350, ANDA206485, ANDA207967 +2
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 |
|---|---|---|---|
| 24 container in 1 case / 50 mL in 1 container | 0264-4205-52 | B. Braun Medical | 26 April 2021 |
| 40 bag in 1 carton / 50 mL in 1 bag | 0338-1719-40 | Baxter Healthcare | 1 June 2020 |
| 24 bag in 1 case / 50 mL in 1 bag | 63323-107-05 | Fresenius Kabi | 15 March 2016 |
| 24 pouch in 1 carton / 1 bag in 1 pouch / 50 mL in 1 bag | 44567-424-24 | WG Critical Care | 9 January 2018 |
| 24 pouch in 1 carton / 1 bag in 1 pouch / 50 mL in 1 bag | 83634-501-81 | Avenacy | 22 April 2024 |
| 30 pouch in 1 carton / 1 bag in 1 pouch / 50 mL in 1 bag | 83634-501-82 | Avenacy | 15 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 8 September 1986 | 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 Magnesium sulfate
Clinical summary
Magnesium sulfate is a calculi dissolution agent indicated for the prevention and control of seizures in a pre-eclampsia and eclampsia, respectively. It is available as injection for intravenous and intramuscular use. MedsAcross supplies Magnesium sulfate 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 Magnesium sulfateFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Magnesium Sulfate prescribing information (Fresenius Kabi) · U.S. National Library of Medicine, DailyMed
Need Magnesium sulfate 4 g/50 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.