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Medicine

Magnesium sulfate 2000 mg/50 mL injection

Magnesium sulfate · Intravenous
Available on requestPrescription onlyUS FDAGeneric name

Magnesium sulfate 2000 mg/50 mL injection is a generic prescription medicine for intravenous use, made by 13 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

Available on request

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
2000 mg/50 mL
Dosage form
Injection
Route
Intravenous
Packs
24 pouches of 50 mL, 24 bags of 50 mL, 15 pouches of 50 mL and 17 more
Manufacturers
Gland PharmaIndiaSun Pharmaceutical IndustriesIndiaHealthFirstAmneal PharmaceuticalsAvenacyFresenius KabiHospiraWG Critical CareAthenex Pharmaceutical DivisionB. Braun Medical
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
22 August 2005
Identifiers
RxCUI 829734, 1658259, 1658262 +3DailyMed set ID 752f55bb-c4ca-4545-94b3-3deea66888d4, 9947731b-fb0f-0c68-e053-2a95a90a815e, efadcb55-f935-4c60-b2e2-0a76b9194b50 +13NDC 44567-420, 51662-1373, 47335-992 +13Application ANDA207350, ANDA206485, ANDA213917 +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.

PackCodeLabelerMarketed since
24 pouch in 1 case / 1 bag in 1 pouch / 50 mL in 1 bag68083-396-01Gland PharmaIndia10 July 2020
24 pouch in 1 case / 1 bag in 1 pouch / 50 mL in 1 bag47335-992-01Sun Pharmaceutical IndustriesIndia1 August 2021
24 bag in 1 case / 50 mL in 1 bag63323-106-05Fresenius Kabi15 March 2016
24 bag in 1 case / 50 mL in 1 bag63323-106-26Fresenius Kabi15 March 2016
24 pouch in 1 case / 1 bag in 1 pouch / 50 mL in 1 bag0409-5239-24Hospira24 August 2026
24 pouch in 1 case / 1 bag in 1 pouch / 50 mL in 1 bag0409-6729-24Hospira21 November 2006
24 pouch in 1 carton / 1 bag in 1 pouch / 50 mL in 1 bag44567-170-24WG Critical Care9 January 2018
24 pouch in 1 carton / 1 bag in 1 pouch / 50 mL in 1 bag44567-420-24WG Critical Care9 January 2018
15 pouch in 1 carton / 1 bag in 1 pouch / 50 mL in 1 bag70121-1719-2Amneal Pharmaceuticals8 January 2024
24 pouch in 1 carton / 1 bag in 1 pouch / 50 mL in 1 bag70121-1719-9Amneal Pharmaceuticals20 February 2023
24 pouch in 1 carton / 1 bag in 1 pouch / 50 mL in 1 bag70860-501-81Athenex Pharmaceutical Division31 January 2023
24 container in 1 case / 50 mL in 1 container0264-4204-52B. Braun Medical26 April 2021
40 bag in 1 carton / 50 mL in 1 bag0338-1708-40Baxter Healthcare1 June 2020
10 bag in 1 carton / 50 mL in 1 bag25021-612-81Sagent Pharmaceuticals15 February 2021
50 mL in 1 bag51662-1352-1HealthFirst21 December 2018
24 pouch in 1 case / 1 bag in 1 pouch / 50 mL in 1 bag51662-1352-3HealthFirst1 August 2022
50 mL in 1 bag51662-1373-1HealthFirst9 December 2019
24 pouch in 1 carton / 1 bag in 1 pouch / 50 mL in 1 bag83634-500-81Avenacy22 April 2024
30 pouch in 1 carton / 1 bag in 1 pouch / 50 mL in 1 bag83634-500-83Avenacy15 September 2025
40 bag in 1 carton / 50 mL in 1 bag72572-511-40Civica25 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.

RegisterStatusSource
US FDAListed, marketedSource record for this pageChecked 12 November 2026
US FDAFirst approved 8 September 1986Drugs@FDA
EU (EMA)Not recorded—
India (CDSCO)Not yet confirmed against CDSCO approval lists—
United StatesRegisteredUS 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 sulfate

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

Data sources

Need Magnesium sulfate 2000 mg/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.