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Medicine

Magnesium sulfate, Potassium sulfate and Sodium sulfate 1.6 g/3.13 g/17.5 g per 177 mL oral solution

Available on requestPrescription onlyUS FDAGeneric name

Magnesium sulfate, Potassium sulfate and Sodium sulfate 1.6 g/3.13 g/17.5 g per 177 mL oral solution is a generic prescription medicine for oral use, made by 6 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). Excursions permitted between 15° to 30°C…

Key facts

Active ingredient (INN)
Magnesium sulfate, Potassium sulfate and Sodium sulfate
Brand
Sold under the generic name
Strength
1.6 g/3.13 g/17.5 g per 177 mL
Dosage form
Oral solution
Route
Oral
Packs
2 bottles and 3 more
Manufacturers
Camber PharmaceuticalsIndiaLupinIndiaMacleods PharmaceuticalsIndiaNovel LaboratoriesIndiaBionpharmaNorthStar RxLLC
Origin register
US FDA, United States
Storage
Store at 20° to 25°C (68° to 77°F). Excursions permitted between 15° to 30°C (59° to 86°F). "Pediatric use information is approved for Braintree Laboratories, Inc.’s SUPREPBOWEL PREP KIT (sodium sulfate, potassium sulfate, and magnesium sulfate) oral solution.
Cold chain
Not required on record
Prescription status
Prescription only
Controlled substance
Not recorded as controlled
HS code (indicative)
3004.90Indicative only. Your customs broker confirms the final tariff code.
Marketing category
marketed
Marketed since
23 February 2017
Identifiers
RxCUI 1120068, 1001689DailyMed set ID e56e8f90-51f5-4f51-9b6b-a6f5a2e499cc, af53cca9-d7db-4723-ad7a-bee09484dbb0, d4883657-d27d-4056-a567-5fb12d5e05d1 +3NDC 33342-546, 40032-700, 43386-700 +3Application ANDA219429, ANDA202511, ANDA204135 +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
2 bottle, plastic in 1 carton / 177 mL in 1 bottle, plastic31722-098-31Camber PharmaceuticalsIndia18 October 2024
2 bottle in 1 carton / 177 mL in 1 bottle43386-700-83LupinIndia30 December 2022
2 bottle in 1 carton / 177 mL in 1 bottle33342-546-53Macleods PharmaceuticalsIndia31 August 2026
2 bottle in 1 carton / 177 mL in 1 bottle40032-700-83Novel LaboratoriesIndia23 February 2017
2 bottle, plastic in 1 kit / 177 mL in 1 bottle, plastic69452-428-62Bionpharma15 April 2025
2 bottle, plastic in 1 carton / 177 mL in 1 bottle, plastic72603-278-02NorthStar RxLLC1 March 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 5 August 2010Drugs@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

Clinical summary

Magnesium sulfate, Potassium sulfate and Sodium sulfate is a fixed-dose combination of an osmotic laxative, a calculi dissolution agent and a potassium salt. It is available as oral solution. MedsAcross supplies Magnesium sulfate, Potassium sulfate and Sodium 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, Potassium sulfate and Sodium sulfate

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

Need Magnesium sulfate, Potassium sulfate and Sodium sulfate 1.6 g/3.13 g/17.5 g per 177 mL oral solution 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.