Skip to content
MedsAcross

Medicine

Sevelamer 800 mg powder for oral suspension

Sevelamer · Oral
Available on requestPrescription onlyUS FDAGeneric name

Sevelamer 800 mg powder for oral suspension is a generic prescription medicine for oral use, made by 7 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)
Sevelamer
Brand
Sold under the generic name
Strength
800 mg
Dosage form
Powder for oral suspension
Route
Oral
Packs
90 pouches, 90 packets and 4 more
Manufacturers
Aurobindo PharmaIndiaDr. Reddy's LaboratoriesIndiaMacleods PharmaceuticalsIndiaAmneal Pharmaceuticals of New YorkBionpharmaNorthStar RxLLCSanofi-Aventis
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). Protect from moisture
Cold chain
Not required on record
Prescription status
Prescription only
Controlled substance
Not recorded as controlled
ATC code
V03AE02 Sevelamer
HS code (indicative)
3004.90Indicative only. Your customs broker confirms the final tariff code.
Marketing category
marketed
Marketed since
13 June 2017
Identifiers
RxCUI 861375, 861370, 749206DailyMed set ID 5baf3742-5929-42f8-8865-6b3e92647d5b, ea201bff-cdfb-4304-bdb1-d05c1dac2677, da5239fe-060b-4469-95ac-173adec43b9c +4NDC 72603-398, 65862-930, 0115-1365 +4Application ANDA207291, ANDA207624, ANDA211316 +3

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
90 pouch in 1 carton / 1 powder, for suspension in 1 pouch65862-930-90Aurobindo PharmaIndia13 June 2017
90 packet in 1 carton / 1 powder, for suspension in 1 packet43598-478-90Dr. Reddy's LaboratoriesIndia25 October 2018
90 packet in 1 carton / 1 powder, for suspension in 1 packet33342-288-68Macleods PharmaceuticalsIndia26 April 2024
90 packet in 1 carton / 1 powder, for suspension in 1 packet0115-1365-29Amneal Pharmaceuticals of New York20 November 2020
90 packet in 1 carton / 1 powder, for suspension in 1 packet69452-126-19Bionpharma1 October 2021
90 packet in 1 box / 1 powder, for suspension in 1 packet0955-1052-90Sanofi-Aventis1 January 2018
90 packet in 1 carton / 1 powder, for suspension in 1 packet72603-398-02NorthStar RxLLC1 January 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 30 October 1998Drugs@FDA
EU (EMA)AuthorisedEMA medicines data
India (CDSCO)Not yet confirmed against CDSCO approval lists—
AustriaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BelgiumRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BulgariaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CroatiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CyprusRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CzechiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
DenmarkRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
EstoniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FinlandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FranceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GermanyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GreeceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
HungaryRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IcelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IrelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
ItalyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LatviaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LiechtensteinRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LithuaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LuxembourgRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
MaltaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NetherlandsRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NorwayRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PolandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PortugalRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
RomaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SlovakiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SloveniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SpainRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SwedenRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
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

Alternatives

Other makers and brands of Sevelamer 800 mg powder for oral suspension.

Compare 1

Other strengths and forms of Sevelamer

Clinical summary

Sevelamer is a phosphate binder indicated for the control of serum phosphorus in adults and children 6 years of age and older with chronic kidney disease (CKD) on dialysis. MedsAcross supplies Sevelamer 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 Sevelamer

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

Data sources

Need Sevelamer 800 mg powder for oral 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.