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Medicine

Sevelamer 800 mg tablet

Sevelamer · Oral
Available on requestPrescription onlyUS FDAGeneric name

Sevelamer 800 mg tablet is a generic prescription medicine for oral use, made by 31 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 25°C (77°F): excursions permitted to 15°C–30°C (59°F–86°F). Protect…

Key facts

Active ingredient (INN)
Sevelamer
Brand
Sold under the generic name
Strength
800 mg
Dosage form
Tablet
Route
Oral
Packs
1000 tablets, 270 tablets, 10 blister pack and 69 more
Manufacturers
Zydus LifesciencesIndiaMacleods PharmaceuticalsIndiaAurobindo PharmaIndiaDr. Reddy's LaboratoriesIndiaCiplaIndiaGlenmark PharmaceuticalsIndiaStrides PharmaIndiaLupinIndiaAmneal PharmaceuticalsExelan Pharmaceuticals31 labelers on the register
Origin register
US FDA, United States
Storage
Store at 25°C (77°F): excursions permitted to 15°C–30°C (59°F–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
17 July 2017
Identifiers
RxCUI 749206, 861370, 861375 +2DailyMed set ID 3abc32fe-1bfc-4759-8f7c-36095e221b06, 2ccf62c6-dbad-416d-8e02-631795bd7517, a56c857e-bc39-484c-908d-f5957857efbb +37NDC 0955-1050, 70710-2170, 70748-173 +37Application NDA022127, ANDA219931, ANDA213145 +14

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

A sample of 42 packs from 31 labelers. The register lists 72 packs for this generic presentation, and we confirm the exact pack on the quote.

PackCodeLabelerMarketed since
1000 tablet, film coated in 1 bottle68382-824-10Zydus LifesciencesIndia17 September 2020
270 tablet, film coated in 1 bottle68382-824-27Zydus LifesciencesIndia17 September 2020
10 blister pack in 1 carton / 10 tablet, film coated in 1 blister pack68382-824-77Zydus LifesciencesIndia17 September 2020
180 tablet, film coated in 1 bottle70710-2058-8Zydus LifesciencesIndia1 March 2025
30 tablet, film coated in 1 bottle70710-2170-3Zydus LifesciencesIndia1 April 2026
180 tablet, film coated in 1 bottle70710-2170-7Zydus LifesciencesIndia1 April 2026
270 tablet, film coated in 1 bottle70710-2170-8Zydus LifesciencesIndia1 April 2026
1000 tablet, film coated in 1 bottle70771-1520-0Zydus LifesciencesIndia17 September 2020
10 blister pack in 1 carton / 10 tablet, film coated in 1 blister pack70771-1520-4Zydus LifesciencesIndia17 September 2020
270 tablet, film coated in 1 bottle70771-1520-8Zydus LifesciencesIndia17 September 2020
180 tablet, film coated in 1 bottle59651-088-18Aurobindo PharmaIndia11 July 2023
180 tablet, film coated in 1 bottle65862-921-18Aurobindo PharmaIndia17 July 2017
270 tablet, film coated in 1 bottle65862-921-27Aurobindo PharmaIndia17 July 2017
30 tablet, film coated in 1 bottle65862-921-30Aurobindo PharmaIndia17 July 2017
270 tablet, film coated in 1 bottle69097-893-93CiplaIndia26 October 2017
270 tablet, film coated in 1 bottle69097-967-93CiplaIndia8 August 2019
14 blister pack in 1 carton / 10 tablet, film coated in 1 blister pack33342-215-56Macleods PharmaceuticalsIndia31 October 2025
180 tablet, film coated in 1 bottle33342-215-57Macleods PharmaceuticalsIndia13 March 2026
270 tablet, film coated in 1 bottle33342-215-58Macleods PharmaceuticalsIndia19 April 2023
30 tablet, film coated in 1 bottle33342-242-07Macleods PharmaceuticalsIndia26 May 2023
180 tablet, film coated in 1 bottle33342-242-57Macleods PharmaceuticalsIndia26 May 2023
25 blister pack in 1 carton / 4 tablet, film coated in 1 blister pack55111-789-11Dr. Reddy's LaboratoriesIndia12 December 2018
270 tablet, film coated in 1 bottle55111-789-27Dr. Reddy's LaboratoriesIndia29 September 2017
30 tablet, film coated in 1 bottle55111-789-30Dr. Reddy's LaboratoriesIndia29 September 2017
90 tablet, film coated in 1 bottle55111-789-90Dr. Reddy's LaboratoriesIndia29 September 2017
180 tablet, film coated in 1 bottle68462-447-18Glenmark PharmaceuticalsIndia8 February 2019
30 tablet, film coated in 1 bottle68462-447-30Glenmark PharmaceuticalsIndia8 February 2019
180 tablet in 1 bottle70748-173-26LupinIndia25 February 2022
30 tablet in 1 bottle64380-872-04Strides PharmaIndia2 July 2024
270 tablet in 1 bottle64380-872-67Strides PharmaIndia2 July 2024
270 tablet, film coated in 1 bottle76282-407-27Exelan Pharmaceuticals8 November 2017
270 tablet, film coated in 1 bottle76282-664-27Exelan Pharmaceuticals8 August 2019
270 tablet, film coated in 1 bottle0955-1050-27Sanofi-Aventis1 February 2018
270 tablet, film coated in 1 bottle0955-1057-30Sanofi-Aventis14 July 2023
270 tablet in 1 bottle11788-116-07AiPing Pharmaceutical15 December 2025
30 tablet, film coated in 1 bottle65162-058-03Amneal Pharmaceuticals13 July 2023
60 tablet, film coated in 1 bottle65162-058-06Amneal Pharmaceuticals13 July 2023
90 tablet, film coated in 1 bottle65162-058-09Amneal Pharmaceuticals28 November 2017
1000 tablet, film coated in 1 bottle65162-058-11Amneal Pharmaceuticals28 November 2017
270 tablet, film coated in 1 bottle65162-058-27Amneal Pharmaceuticals28 November 2017
10 blister pack in 1 bag / 1 tablet, film coated in 1 blister pack55154-2647-0—25 February 2025
50 blister pack in 1 carton / 1 tablet, film coated in 1 blister pack0904-7209-06—19 August 2024

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 tablet.

Compare all 2

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 tablet 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.