Quick answers
- What is Sevelamer carbonate used for?
- The FDA-approved label (Renvela, Genzyme Corporation, November 25, 2025) says: “Renvela ® (sevelamer carbonate) is indicated for the control of serum phosphorus in adults and children 6 years of age and older with chronic kidney disease (CKD) on dialysis. Renvela ® 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 on dialysis.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Sevelamer carbonate have a boxed warning?
- No. None of the 41 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Sevelamer carbonate?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Sevelamer carbonate been recalled?
- FDA enforcement reports list 1 recall of products of this medicine; the newest started June 26, 2024 (Class III). A recall usually concerns specific lots, not every product.
- Who makes Sevelamer carbonate?
- 35 companies list prescription products of Sevelamer carbonate in the FDA NDC Directory, including Sanofi-Aventis U.S. LLC, Genzyme Corporation and Macleods Pharmaceuticals Limited.
What Sevelamer carbonate is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Renvela ® (sevelamer carbonate) is indicated for the control of serum phosphorus in adults and children 6 years of age and older with chronic kidney disease (CKD) on dialysis. Renvela ® 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 on dialysis.
— FDA label: Renvela, Genzyme Corporation, effective November 25, 2025. Read the full label on DailyMed →
The FDA has 41 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 41 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet, film coated · Powder, for suspension · Tablet · For suspension |
|---|---|
| Route | Oral |
| Prescription products | 53 in the FDA NDC Directory |
| Brand names | Renvela |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| sevelamer carbonate 0.8 g powder, for suspension | Generic | $0.8791 per unit |
| sevelamer carbonate 2.4 g powder, for suspension | Generic | $0.9864 per unit |
| sevelamer carbonate 2400 mg powder, for suspension | Generic | $0.9864 per unit |
| sevelamer carbonate 2400 mg/2790 mg for suspension | Generic | $0.9864 per unit |
| sevelamer carbonate 800 mg powder, for suspension | Generic | $0.8791 per unit |
| sevelamer carbonate 800 mg tablet | Generic | $0.2136 per tablet |
| sevelamer carbonate 800 mg tablet, film coated | Generic | $0.2136 per tablet |
| sevelamer carbonate 800 mg tablet, film coated | Brand: Renvela | $5.69 per tablet |
| sevelamer carbonate 800 mg/930 mg for suspension | Generic | $0.8791 per unit |
NADAC list of November 4, 2026; these prices took effect between April 22, 2026 and October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Sanofi-Aventis U.S. LLC4 products
- Genzyme Corporation3 products
- Macleods Pharmaceuticals Limited3 products
- Strides Pharma Science Limited3 products
- Aurobindo Pharma Limited3 products
- Bionpharma Inc.2 products
- Dr.Reddys Laboratories Inc2 products
- Cipla USA Inc.2 products
- Zydus Pharmaceuticals USA Inc.2 products
- Exelan Pharmaceuticals Inc.2 products
- Amneal Pharmaceuticals of New York LLC2 products
- Cardinal Health 107, LLC2 products
- NorthStar Rx LLC1 product
- Precision Dose, Inc.1 product
- Bryant Ranch Prepack1 product
- Major Pharmaceuticals1 product
- Atlantic Biologicals Corp.1 product
- AvPAK1 product
- TWi Pharmaceuticals, Inc.1 product
- AvKARE1 product
- AiPing Pharmaceutical, Inc.1 product
- American Health Packaging1 product
- Marp Pharma1 product
- Insignamedex LLC1 product
- Dr. Reddy's Laboratories Limited1 product
- Navinta LLC1 product
- Westminster Pharmaceuticals, LLC1 product
- Zydus Lifesciences Limited1 product
- NCS HealthCare of KY, LLC dba Vangard Labs1 product
- Amneal Pharmaceuticals LLC1 product
- NorthStar RxLLC1 product
- Proficient Rx LP1 product
- PD-Rx Pharmaceuticals, Inc.1 product
- Golden State Medical Supply, Inc.1 product
- Shandong Xinhua Pharmaceutical Co., Ltd.1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA022127 RENVELA | Sanofi | October 19, 2007 | 6, latest June 6, 2023 2023: Labeling · 2020: Labeling · 2016: Efficacy |
| NDA022318 RENVELA | Genzyme | August 12, 2009 | 5, latest April 30, 2020 2020: Labeling · 2016: Efficacy · 2016: Labeling |
Generic approvals (17)
- ANDA207624Aurobindo Pharma · June 13, 2017
- ANDA207179Aurobindo Pharma · July 17, 2017
- ANDA206094DR Reddys · September 29, 2017
- ANDA203860Invagen Pharms · October 26, 2017
- ANDA207288Amneal Pharms Co · November 28, 2017
- ANDA200959Quagen · March 20, 2018
- ANDA210464DR Reddys · October 25, 2018
- ANDA212970Epic Pharma LLC · April 9, 2020
- ANDA207759Zydus Pharms · August 11, 2020
- ANDA211316Impax · November 20, 2020
- ANDA209374Bionpharma · May 17, 2021
- ANDA206100Macleods Pharms · April 19, 2023
- ANDA211917Strides Pharma Intl · September 8, 2023
- ANDA207291Macleods Pharms · April 25, 2024
- ANDA211915Strides Pharma · May 9, 2024
- ANDA215998Shandong Xinhua · October 24, 2024
- ANDA219931Navinta LLC · October 27, 2025
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
June 26, 2024 · Class III · Ongoing · D-0625-2024
Labeling: Incorrect or Missing Lot and/or Exp Date. Missing lot number and expiration dates on packets
Sevelamer Carbonate for Oral Suspension 0.8g packets, packaged in 90 packets per container, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India NDC 43598-478-90 — Dr. Reddy's Laboratories, Inc.
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Renvela, Genzyme Corporation, effective November 25, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →