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Medicine

Sevelamer 800 mg tablet

Sevelamer · Parenteral
Available on requestPrescription onlyUS FDAGeneric name

Sevelamer 800 mg tablet is a generic prescription medicine for parenteral use, made by 2 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°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C…

Key facts

Active ingredient (INN)
Sevelamer
Brand
Sold under the generic name
Strength
800 mg
Dosage form
Tablet
Route
Parenteral
Packs
10 blister pack, 50 blister pack
Manufacturers
Cardinal HealthMajor Pharmaceuticals
Origin register
US FDA, United States
Storage
Store at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F). Protect from moisture and store in a dry place.
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
19 August 2024
Identifiers
RxCUI 857224DailyMed set ID 0500034d-458c-42c5-918d-9acd22f0c28b, c13532a7-4c56-4084-839d-3dcfd4dc30f8NDC 0904-7209, 55154-2647Application ANDA204724

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
10 blister pack in 1 bag / 1 tablet, film coated in 1 blister pack55154-2647-0Cardinal Health25 February 2025
50 blister pack in 1 carton / 1 tablet, film coated in 1 blister pack0904-7209-06Major Pharmaceuticals19 August 2024
1000 tablet, film coated in 1 bottle68382-824-10—17 September 2020
270 tablet, film coated in 1 bottle68382-824-27—17 September 2020
10 blister pack in 1 carton / 10 tablet, film coated in 1 blister pack68382-824-77—17 September 2020
180 tablet, film coated in 1 bottle70710-2058-8—1 March 2025
30 tablet, film coated in 1 bottle70710-2170-3—1 April 2026
180 tablet, film coated in 1 bottle70710-2170-7—1 April 2026
270 tablet, film coated in 1 bottle70710-2170-8—1 April 2026
1000 tablet, film coated in 1 bottle70771-1520-0—17 September 2020
10 blister pack in 1 carton / 10 tablet, film coated in 1 blister pack70771-1520-4—17 September 2020
270 tablet, film coated in 1 bottle70771-1520-8—17 September 2020
180 tablet, film coated in 1 bottle59651-088-18—11 July 2023
180 tablet, film coated in 1 bottle65862-921-18—17 July 2017
270 tablet, film coated in 1 bottle65862-921-27—17 July 2017
30 tablet, film coated in 1 bottle65862-921-30—17 July 2017
270 tablet, film coated in 1 bottle69097-893-93—26 October 2017
270 tablet, film coated in 1 bottle69097-967-93—8 August 2019
14 blister pack in 1 carton / 10 tablet, film coated in 1 blister pack33342-215-56—31 October 2025
180 tablet, film coated in 1 bottle33342-215-57—13 March 2026
270 tablet, film coated in 1 bottle33342-215-58—19 April 2023
30 tablet, film coated in 1 bottle33342-242-07—26 May 2023
180 tablet, film coated in 1 bottle33342-242-57—26 May 2023
25 blister pack in 1 carton / 4 tablet, film coated in 1 blister pack55111-789-11—12 December 2018
270 tablet, film coated in 1 bottle55111-789-27—29 September 2017
30 tablet, film coated in 1 bottle55111-789-30—29 September 2017
90 tablet, film coated in 1 bottle55111-789-90—29 September 2017
180 tablet, film coated in 1 bottle68462-447-18—8 February 2019
30 tablet, film coated in 1 bottle68462-447-30—8 February 2019
180 tablet in 1 bottle70748-173-26—25 February 2022
30 tablet in 1 bottle64380-872-04—2 July 2024
270 tablet in 1 bottle64380-872-67—2 July 2024
270 tablet, film coated in 1 bottle76282-407-27—8 November 2017
270 tablet, film coated in 1 bottle76282-664-27—8 August 2019
270 tablet, film coated in 1 bottle0955-1050-27—1 February 2018
270 tablet, film coated in 1 bottle0955-1057-30—14 July 2023
270 tablet in 1 bottle11788-116-07—15 December 2025
30 tablet, film coated in 1 bottle65162-058-03—13 July 2023
60 tablet, film coated in 1 bottle65162-058-06—13 July 2023
90 tablet, film coated in 1 bottle65162-058-09—28 November 2017
1000 tablet, film coated in 1 bottle65162-058-11—28 November 2017
270 tablet, film coated in 1 bottle65162-058-27—28 November 2017

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.