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.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| NDA 022127 | SANOFI | 2007-10-19 | 3 |
| NDA 022318 | GENZYME | 2009-08-12 | 4 |
| ANDA 207624 | AUROBINDO PHARMA | 2017-06-13 | 2 |
| ANDA 207179 | AUROBINDO PHARMA | 2017-07-17 | 6 |
| ANDA 206094 | DR REDDYS | 2017-09-29 | 4 |
| ANDA 203860 | INVAGEN PHARMS | 2017-10-26 | 4 |
| ANDA 207288 | AMNEAL PHARMS CO | 2017-11-28 | 3 |
| ANDA 200959 | QUAGEN | 2018-03-20 | 4 |
| ANDA 210464 | DR REDDYS | 2018-10-25 | 2 |
| ANDA 204724 | GLENMARK PHARMS LTD | 2019-02-08 | 5 |
| ANDA 212970 | EPIC PHARMA LLC | 2020-04-09 | 2 |
| ANDA 207759 | ZYDUS PHARMS | 2020-08-11 | 2 |
| ANDA 211316 | IMPAX | 2020-11-20 | 2 |
| ANDA 209374 | BIONPHARMA | 2021-05-17 | 2 |
| ANDA 213145 | LUPIN | 2021-06-16 | 1 |
| ANDA 206100 | MACLEODS PHARMS | 2023-04-19 | 2 |
| ANDA 206883 | MACLEODS PHARMS | 2023-05-26 | 4 |
| ANDA 212599 | AUROBINDO PHARMA LTD | 2023-07-11 | 2 |
| ANDA 211917 | STRIDES PHARMA INTL | 2023-09-08 | 2 |
| ANDA 207291 | MACLEODS PHARMS | 2024-04-25 | 3 |
| ANDA 211915 | STRIDES PHARMA | 2024-05-09 | 1 |
| ANDA 215998 | SHANDONG XINHUA | 2024-10-24 | 3 |
| ANDA 218966 | NAVINTA LLC | 2025-02-03 | 1 |
| ANDA 219931 | NAVINTA LLC | 2025-10-27 | 2 |
Official labeling on DailyMed
- SEVELAMER CARBONATE TABLET, FILM COATED [BRYANT RANCH PREPACK] · version 102 · 2026-08-31
- SEVELAMER CARBONATE POWDER, FOR SUSPENSION [NORTHSTAR RXLLC] · version 2 · 2026-07-17
- SEVELAMER CARBONATE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED] · version 7 · 2026-07-13
- SEVELAMER HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] · version 5 · 2026-06-26
- SEVELAMER CARBONATE TABLET, FILM COATED [MARP PHARMA] · version 3 · 2026-06-18
- SEVELAMER CARBONATE FOR SUSPENSION [STRIDES PHARMA SCIENCE LIMITED] · version 7 · 2026-06-08
- SEVELAMER CARBONATE TABLET, FILM COATED [INSIGNAMEDEX LLC] · version 2 · 2026-05-25
- SEVELAMER CARBONATE TABLET [PD-RX PHARMACEUTICALS, INC.] · version 2 · 2026-04-20
- SEVELAMER CARBONATE TABLET [STRIDES PHARMA SCIENCE LIMITED] · version 8 · 2026-04-02
- SEVELAMER CARBONATE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS USA INC.] · version 1 · 2026-04-02
- SEVELAMER HYDROCHLORIDE TABLET, FILM COATED [CARDINAL HEALTH 107, LLC] · version 2 · 2026-03-05
- SEVELAMER HYDROCHLORIDE TABLET, FILM COATED [MAJOR PHARMACEUTICALS] · version 3 · 2026-02-19
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.