Medicine
Sodium polystyrene sulfonate 15 g/60 mL rectal suspension
Sodium polystyrene sulfonate 15 g/60 mL rectal suspension is a generic prescription medicine for oral, rectal use, made by 3 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°-25°C (68°-77°F), excursions permitted to 15°-30°C (59°-86°F).
Key facts
- Active ingredient (INN)
- Sodium polystyrene sulfonate
- Brand
- Sold under the generic name
- Strength
- 15 g/60 mL
- Dosage form
- Rectal suspension
- Route
- Oral, rectal
- Packs
- 10 bottles, 473 mL, 120 mL and 3 more
- Manufacturers
- CMP PharmaBurel PharmaceuticalsCardinal Health
- Origin register
- US FDA, United States
- Storage
- Store at 20°-25°C (68°-77°F), excursions permitted to 15°-30°C (59°-86°F).
- 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
- 8 December 1982
- Identifiers
- RxCUI 313072DailyMed set ID 8bbeae67-a7ff-4fa6-b21e-fb8617cd9197, 12d48dcf-07bd-4b06-bd6c-7543f1be8357, 3c3b02a3-9a75-40a5-889d-97318faf881fNDC 35573-108, 46287-006, 55154-7353Application ANDA214912, ANDA087859
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 bottle, unit-dose in 1 carton / 60 mL in 1 bottle, unit-dose | 35573-108-14 | Burel Pharmaceuticals | 18 December 2025 |
| 473 mL in 1 bottle | 35573-108-57 | Burel Pharmaceuticals | 19 June 2026 |
| 473 mL in 1 bottle | 46287-006-01 | CMP Pharma | 8 December 1982 |
| 120 mL in 1 bottle | 46287-006-04 | CMP Pharma | 16 July 1987 |
| 10 bottle, unit-dose in 1 carton / 60 mL in 1 bottle, unit-dose | 46287-006-60 | CMP Pharma | 12 December 1985 |
| 2 bottle, unit-dose in 1 bag / 60 mL in 1 bottle, unit-dose | 55154-7353-2 | Cardinal Health | 1 January 1983 |
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 5 June 1958 | 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 Sodium polystyrene sulfonate
Clinical summary
Sodium polystyrene sulfonate is a potassium binder indicated for the treatment of hyperkalemia. It is available as powder for oral suspension, rectal suspension and oral powder. MedsAcross supplies Sodium polystyrene sulfonate 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 Sodium polystyrene sulfonateFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Kionex prescribing information (ANI Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Sodium polystyrene sulfonate 15 g/60 mL rectal suspension 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.