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Active ingredient

Sevelamer

66 finished FDA listings contain Sevelamer as their only active ingredient.

FDA NDC Directory

Ingredient names as written by FDA
SEVELAMER CARBONATE, SEVELAMER HYDROCHLORIDE
Dosage forms
For Suspension, Powder, For Suspension, Tablet, Tablet, Film Coated
Routes
Oral, Parenteral
Manufacturers / labelers
37
Strengths listed
.8 g/1 · 2.4 g/1 · 2400 mg/1 · 2400 mg/2790mg · 400 mg/1 · 800 mg/1 · 800 mg/930mg
Brand names in FDA listings
Renvela

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 214824

Drugs@FDA applications

Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.

ApplicationSponsorOriginal approvalListings
NDA 022127SANOFI2007-10-193
NDA 022318GENZYME2009-08-124
ANDA 207624AUROBINDO PHARMA2017-06-132
ANDA 207179AUROBINDO PHARMA2017-07-176
ANDA 206094DR REDDYS2017-09-294
ANDA 203860INVAGEN PHARMS2017-10-264
ANDA 207288AMNEAL PHARMS CO2017-11-283
ANDA 200959QUAGEN2018-03-204
ANDA 210464DR REDDYS2018-10-252
ANDA 204724GLENMARK PHARMS LTD2019-02-085
ANDA 212970EPIC PHARMA LLC2020-04-092
ANDA 207759ZYDUS PHARMS2020-08-112
ANDA 211316IMPAX2020-11-202
ANDA 209374BIONPHARMA2021-05-172
ANDA 213145LUPIN2021-06-161
ANDA 206100MACLEODS PHARMS2023-04-192
ANDA 206883MACLEODS PHARMS2023-05-264
ANDA 212599AUROBINDO PHARMA LTD2023-07-112
ANDA 211917STRIDES PHARMA INTL2023-09-082
ANDA 207291MACLEODS PHARMS2024-04-253
ANDA 211915STRIDES PHARMA2024-05-091
ANDA 215998SHANDONG XINHUA2024-10-243
ANDA 218966NAVINTA LLC2025-02-031
ANDA 219931NAVINTA LLC2025-10-272

Official labeling on DailyMed

Showing the 12 most recent of 52 labels.

Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.