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Medicine

Magnesium sulfate 5000 mg/10 mL injection

Magnesium sulfate · Intramuscular, intravenous
Available on requestPrescription onlyUS FDAGeneric name

Magnesium sulfate 5000 mg/10 mL injection is a generic prescription medicine for intramuscular, intravenous use, made by 9 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

Store at 20° to 25°C (68° to 77°F).

Key facts

Active ingredient (INN)
Magnesium sulfate
Brand
Sold under the generic name
Strength
5000 mg/10 mL
Dosage form
Injection
Route
Intramuscular, intravenous
Packs
25 vials of 10 mL, 1 syringe of 10 mL, 10 pouches of 10 mL and 7 more
Manufacturers
Camber PharmaceuticalsIndiaHealth FirstFresenius KabiHenry ScheinHospiraMedical Purchasing SolutionsProPharma DistributionRemedyrepackSquare Pharmaceuticals
Origin register
US FDA, United States
Storage
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
8 August 2000
Identifiers
RxCUI 829762, 1658221, 1658244 +2DailyMed set ID 5a18118e-6370-4473-adb2-084d66667ebc, 7446d09b-10fe-7765-e053-2a91aa0a56a8, e9c10579-29f3-4889-8881-0626f63968d4 +6NDC 76483-129, 51662-1235, 63323-064 +6Application ANDA217461, ANDA075151, NDA019316 +1

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
25 vial, single-dose in 1 carton / 10 mL in 1 vial, single-dose31722-394-33Camber PharmaceuticalsIndia28 May 2025
25 vial, single-dose in 1 tray / 10 mL in 1 vial, single-dose63323-064-11Fresenius Kabi8 August 2000
1 syringe, plastic in 1 carton / 10 mL in 1 syringe, plastic51662-1235-1Health First25 August 2018
10 pouch in 1 case / 1 carton in 1 pouch / 1 syringe, plastic in 1 carton / 10 mL in 1 syringe, plastic51662-1235-3Health First12 June 2022
10 carton in 1 package / 1 syringe, plastic in 1 carton / 10 mL in 1 syringe, plastic0409-1754-10Hospira28 November 2006
25 vial in 1 carton / 10 mL in 1 vial76483-129-03Square Pharmaceuticals30 October 2026
1 syringe, plastic in 1 bag / 10 mL in 1 syringe, plastic0404-9903-10Henry Schein12 January 2022
1 vial, single-dose in 1 bag / 10 mL in 1 vial, single-dose71872-7229-1Medical Purchasing Solutions13 October 2020
10 mL in 1 vial, single-dose84549-064-11ProPharma Distribution17 September 2025
25 vial, single-dose in 1 tray / 10 mL in 1 vial, single-dose70518-4375-0Remedyrepack28 June 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 5000 mg/10 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.