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Sevelamer Carbonate 800 mg Tablet, Film Coated — NDC 17856-0921-1 (Billing 17856-0921-01)

by ATLANTIC BIOLOGICALS CORP. · 100 POUCH in 1 CASE / 1 TABLET, FILM COATED in 1 POUCH

This is a package of Sevelamer Carbonate 800 mg Tablet, Film Coated from ATLANTIC BIOLOGICALS CORP., marketed since Jun 2018 and currently FDA-listed. It is this product's only package size.

NDC 17856-0921-01
🏷️ FDA NDC (as labeled) 17856-0921-1 billing pads the package segment with a zero
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

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Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 17856-0921-1 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
17856 labeler · 0921 product · 1 package
Package marketed since
May 9, 2024
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 1785609211 1
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 17856-0921-1
Product NDC 17856-0921
11-digit billing NDC 17856092101
RxCUI 749206
UNII 9YCX42I8IU
Application # ANDA207179
SPL Set ID 07b709fd-a2a1-4ff1-ad19-827d38e84562
Established class (EPC) Phosphate Binder
Mechanism of action Phosphate Chelating Activity
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2018-06-27
Route ORAL
Dosage form TABLET, FILM COATED
Substance SEVELAMER CARBONATE
TE code (Orange Book) AB · RLD · RS
Quick answers
  • RxCUI (RxNorm): 749206
Why two NDCs? The FDA registers this code as 17856-0921-1 — a 5-4-1 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the package segment → 17856-0921-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Phosphate Binder class.

Pharmacologic class Phosphate Binder
Drug family (ATC) Drugs for treatment of hyperkalemia and hyperphosphatemia
How it works Phosphate Chelating Activity
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

📗 Our plain-language guide HelloPharmacist
  • It lowers high phosphorus in your blood if you have chronic kidney disease and are on dialysis. It does this by binding phosphate from food in your gut.
  • Take it by mouth with meals, usually three times a day. Your prescriber sets and adjusts the amount based on your blood tests. Follow your pharmacy label.
  • Stomach upset is most common, such as nausea, vomiting, diarrhea, gas, indigestion, and constipation. Call your doctor if constipation is severe or worsening, or if you have severe...
  • Yes. Ciprofloxacin and mycophenolate need to be spaced apart from sevelamer. Tell us if you take levothyroxine, cyclosporine or tacrolimus, since your doctor may separate timing or...
📖 Read our full Sevelamer guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $0.3584 $35.84 / 100 tablet
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
17856-0921-01 You're viewing this Main listing 100 POUCH in 1 CASE / 1 TABLET, FILM COATED in 1 POUCH 2022-09-23 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Sevelamer Carbonate 800 mg 00904-6707-06 Major 1 tablet $0.214 AB Availability likely —
Sevelamer Carbonate 800 mg 11788-0116-07 AiPing 270 tablets $0.214 AB Availability likely —
Sevelamer Carbonate 800 mg 16714-0814-01 NorthStar 270 tablets $0.214 AB Availability likely —
Sevelamer Carbonate 800 mg 24979-0186-46 TWi 270 tablets $0.214 AB Availability likely —
Sevelamer Carbonate 800 mg 33342-0215-58 Macleods 270 tablets $0.214 AB Availability likely —
Sevelamer Carbonate 800 mg 50268-0720-15 AvPAK 1 tablet $0.214 AB Availability likely —
Sevelamer Carbonate 800 mg 55111-0789-11 DR. 4 tablets $0.214 AB Availability likely —
Sevelamer Carbonate 800 mg 60687-0328-31 American 1 tablet $0.214 AB Availability likely —
Sevelamer Carbonate 800 mg 68094-0034-64 Precision 10 tablets $0.214 AB Availability likely —
Sevelamer carbonate 800 mg 69097-0967-93 Cipla 270 tablets $0.214 AB Availability likely —
Sevelamer Carbonate 800 mg 69367-0423-27 Westminster 270 tablets $0.214 AB Availability likely —
Sevelamer carbonate 800 mg 76282-0407-27 Exelan 270 tablets $0.214 AB Availability likely —
Sevelamer carbonate 800 mg 76282-0664-27 Exelan 270 tablets $0.214 AB Availability likely —
Sevelamer Carbonate 800 mg 00955-1050-27 Sanofi-Aventis 270 tablets $0.254 — FDA listed —
Renvela 800 mg 58468-0133-01 Genzyme 270 tablets $5.685 — Availability likely —
Sevelamer Carbonate 800 mg 00615-8239-39 NCS 30 tablets — AB FDA listed —
Sevelamer Carbonate 800 mg 00955-1057-30 Sanofi-Aventis 270 tablets — — FDA listed —
Sevelamer Carbonate 800 mgthis 17856-0921-01 ATLANTIC 1 tablet — AB FDA listed —
Sevelamer Carbonate 800 mg 42571-0378-30 Micro 30 tablets — — Discontinued —
Sevelamer Carbonate 800 mg 51407-0706-27 Golden 270 tablets — AB FDA listed —
Sevelamer Carbonate 800 mg 55154-3358-00 Cardinal 1 tablet — AB FDA listed —
Sevelamer Carbonate 800 mg 55154-8188-00 Cardinal 1 tablet — AB FDA listed —
Sevelamer Carbonate 800 mg 58624-5001-02 Shandong 30 tablets — AB FDA listed —
Sevelamer Carbonate 800 mg 64380-0872-04 Strides 30 tablets — AB FDA listed —
Sevelamer Carbonate 800 mg 65162-0058-09 Amneal 90 tablets — AB FDA listed —
Sevelamer Carbonate 800 mg 65862-0921-18 Aurobindo 180 tablets — AB FDA listed —
Sevelamer carbonate 800 mg 68382-0824-10 Zydus 1000 tablets — AB FDA listed —
Sevelamer carbonate 800 mg 68475-0010-01 Navinta 30 tablets — AB FDA listed —
Sevelamer carbonate 800 mg 69097-0893-93 Cipla 270 tablets — AB FDA listed —
Sevelamer carbonate 800 mg 70710-2170-03 Zydus 30 tablets — AB FDA listed —
Sevelamer carbonate 800 mg 70771-1520-00 Zydus 1000 tablets — AB FDA listed —
Sevelamer Carbonate 800 mg 71205-0966-67 Proficient 270 tablets — AB FDA listed —
Sevelamer Carbonate 800 mg 71335-3021-01 Bryant 50 tablets — AB Discontinued —
Sevelamer Carbonate 800 mg 72162-2499-01 Bryant 100 tablets — AB FDA listed —
Sevelamer Carbonate 800 mg 72789-0562-94 PD-Rx 270 tablets — AB FDA listed —
Sevelamer Carbonate 800 mg 73190-0014-27 AvKARE 270 tablets — AB FDA listed —
Sevelamer Carbonate 800 mg 85898-0101-27 Marp 270 tablets — — FDA listed —
Sevelamer Carbonate 800 mg 87367-0266-12 INSIGNAMEDEX 270 tablets — — FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2018
On the market since
Jun 2018
📍
2026
Currently FDA-listed
8 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerATLANTIC BIOLOGICALS CORP.
Application holderAUROBINDO PHARMA LTD
FDA applicationANDA207179 (ANDA)
Labeler code17856
First marketedJun 2018
Product typeHuman Prescription Drug
Portfolio109 products on file

More NDCs from ATLANTIC BIOLOGICALS CORP. labeler code 17856

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Recent Major Changes 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 84 words ▾

1 INDICATIONS AND USAGE Sevelamer carbonate tablets are indicated for the control of serum phosphorus in adults with chronic kidney disease (CKD) on dialysis. Pediatric use information is approved for Genzyme Corporation’s Renvela (sevelamer carbonate) tablets and Renvela (sevelamer carbonate) for oral suspension. However, due to Genzyme Corporation’s marketing exclusivity rights, these drug products are not labeled with that pediatric information.

Sevelamer carbonate tablets are a phosphate binder indicated for the control of serum phosphorus in adults with chronic kidney disease on dialysis. (1)

⏱️ Dosage and Administration ~2 min read ▾

2 DOSAGE AND ADMINISTRATION Starting dose of sevelamer carbonate tablets is 0.8 or 1.6 grams administered orally three times per day with meals based on serum phosphorus levels for adult patients. ( 2.1 ) Titrate by 0.8 g per meal in two week intervals for adult patients as needed to obtain serum phosphorus target. ( 2.1 )

2.1General Dosing Information Starting Dose for Adult Patients Not Taking a Phosphate Binder. The recommended starting dose of sevelamer carbonate tablets is 0.8 to 1.6 g taken orally with meals based on serum phosphorus level. Table 1 provides recommended starting doses of sevelamer carbonate tablets for adult patients not taking a phosphate binder.

Table 1. Starting Dose for Adult Dialysis Patients Not Taking a Phosphate Binder Serum Phosphorus Sevelamer Carbonate Tablets > 5.5 and < 7.5 mg/dL 0.8 g three times daily with meals ≥ 7.5 mg/dL 1.6 g three times daily with meals Dose Titration for Adult Patients Taking Sevelamer Carbonate Tablets . Titrate the sevelamer carbonate tablets dose by 0.8 g three times per day with meals at two-week intervals as necessary to achieve target serum phosphorus levels.

Based on clinical studies, the average prescribed adult daily dose of sevelamer carbonate is approximately 7.2 g per day. The highest daily adult dose of sevelamer carbonate studied was 14 grams in CKD patients on dialysis. Switching from Sevelamer Hydrochloride (Renagel ® ) Tablets.

For adult patients switching from sevelamer hydrochloride (Renagel ® ) tablets to sevelamer carbonate tablets or powder, use the same dose in grams. Switching between Sevelamer Carbonate Tablets and Powder. Use the same dose in grams.

Switching from Calcium Acetate . Table 3 gives recommended starting doses of sevelamer carbonate tablets based on a patient’s current calcium acetate dose. Table 3.

Starting Dose for Dialysis Patients Switching From Calcium Acetate to Sevelamer Carbonate Tablets Calcium Acetate 667 mg (Tablets per meal) Sevelamer Carbonate Tablets 1 tablet 0.8 g 2 tablets 1.6 g 3 tablets 2.4 g Pediatric use information is approved for Genzyme Corporation’s Renvela (sevelamer carbonate) tablets and Renvela (sevelamer carbonate) for oral suspension. However, due to Genzyme Corporation’s marketing exclusivity rights, these drug products are not labeled with that pediatric information.

💊 Dosage Forms and Strengths 35 words ▾

3 DOSAGE FORMS AND STRENGTHS Tablets: 0.8 g white to off-white, oval shaped, film-coated tablets, imprinted with “J 75” on one side with edible black ink and plain on other side. Tablets: 0.8 g (3)

⛔ Contraindications 52 words ▾

4 CONTRAINDICATIONS Sevelamer carbonate tablets are contraindicated in patients with bowel obstruction. Sevelamer carbonate tablets are contraindicated in patients with known hypersensitivity to sevelamer carbonate, sevelamer hydrochloride, or to any of the excipients. Bowel obstruction. (4) Known hypersensitivity to sevelamer carbonate, sevelamer hydrochloride, or to any of the excipients. ( 4 )

⚠️ Warnings and Cautions 217 words ▾

5 WARNINGS AND PRECAUTIONS Serious cases of dysphagia, bowel obstruction, and perforation have been associated with sevelamer use, some requiring hospitalization and surgery. (5.1)

5.1Gastrointestinal Adverse Events Cases of dysphagia and esophageal tablet retention have been reported in association with use of the tablet formulation of sevelamer, some requiring hospitalization and intervention. Consider using sevelamer suspension in patients with a history of swallowing disorders. Cases of bowel obstruction and perforation have also been reported with sevelamer use.

Patients with dysphagia, swallowing disorders, severe gastrointestinal (GI) motility disorders including severe constipation, or major GI tract surgery were not included in the sevelamer carbonate clinical studies.

5.2Reductions in Vitamins D, E, K (clotting factors) and Folic Acid Levels In preclinical studies in rats and dogs, sevelamer hydrochloride, which contains the same active moiety as sevelamer carbonate, reduced vitamins D, E, and K (coagulation parameters) and folic acid levels at doses of 6 to 10 times the recommended human dose. In short-term clinical trials, there was no evidence of reduction in serum levels of vitamins. However, in a one-year clinical trial, 25-hydroxyvitamin D (normal range 10 to 55 ng/mL) fell from 39 ± 22 ng/mL to 34 ± 22 ng/mL (p<0.01) with sevelamer hydrochloride treatment.

Most (approximately 75%) patients in sevelamer hydrochloride clinical trials were receiving vitamin supplements.

🤒 Adverse Reactions ~2 min read ▾

6 ADVERSE REACTIONS Most of the safety experience is with sevelamer tablets and sevelamer hydrochloride. In long-term studies with sevelamer hydrochloride, which contains the same active moiety as sevelamer carbonate, the most common adverse events included: vomiting (22%), nausea (20%), diarrhea (19%), dyspepsia (16%), abdominal pain (9%), flatulence (8%) and constipation (8%). ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Aurobindo Pharma USA, Inc. at 1-866-850-2876 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. There are limited clinical trial data on the safety of sevelamer carbonate. However, because it contains the same active ingredient as the hydrochloride salt, the adverse event profiles of the two salts are expected to be similar.

In a cross-over study in hemodialysis patients with treatment durations of eight weeks each and no washout, and another cross-over study in hemodialysis patients, with treatment durations of four weeks each and no washout between treatment periods, the adverse reactions on sevelamer carbonate powder were similar to those reported for sevelamer hydrochloride. In a parallel design study of sevelamer hydrochloride with treatment duration of 52 weeks, adverse reactions reported for sevelamer hydrochloride (n=99) were similar to those reported for the active-comparator group (n=101).

Overall adverse reactions among those treated with sevelamer hydrochloride occurring in > 5% of patients included: vomiting (22%), nausea (20%), diarrhea (19%), dyspepsia (16%), abdominal pain (9%), flatulence (8%) and constipation (8%). A total of 27 patients treated with sevelamer and 10 patients treated with comparator withdrew from the study due to adverse reactions. Based on studies of 8 to 52 weeks, the most common reason for withdrawal from sevelamer hydrochloride was gastrointestinal adverse reactions (3 to 16%).

In 143 peritoneal dialysis patients studied for 12 weeks using sevelamer hydrochloride, most common adverse reactions were similar to adverse reactions observed in hemodialysis patients. The most frequently occurring treatment emergent serious adverse reaction was peritonitis (8 reactions in 8 patients [8%] in the sevelamer group and 2 reactions in 2 patients [4%] on active-control). Thirteen patients (14%) in the sevelamer group and 9 patients (20%) in the active-control group discontinued, mostly for gastrointestinal adverse reactions.

6.2Postmarketing Experience Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or to establish a causal relationship to drug exposure. The following adverse reactions have been identified during post-approval use of sevelamer hydrochloride or sevelamer carbonate: hypersensitivity, pruritus, rash, abdominal pain, fecal impaction, and uncommon cases of ileus, intestinal obstruction, and intestinal perforation . Appropriate medical management should be given to patients who develop constipation or have worsening of existing constipation to avoid severe complications.

🔄 Drug Interactions ~1 min read ▾

7 DRUG INTERACTIONS There are no empirical data on avoiding drug interactions between sevelamer carbonate and most concomitant oral drugs. For oral medication where a reduction in the bioavailability of that medication would have a clinically significant effect on its safety or efficacy (e.g., cyclosporine, tacrolimus, levothyroxine), consider separation of the timing of the administration of the two drugs [see Clinical Pharmacology (12.3) ] . The duration of separation depends upon the absorption characteristics of the medication concomitantly administered, such as the time to reach peak systemic levels and whether the drug is an immediate release or an extended release product.

Where possible consider monitoring clinical responses and/or blood levels of concomitant drugs that have a narrow therapeutic range. Table 5. Sevelamer Drug Interactions Oral drugs for which sevelamer did not alter the pharmacokinetics when administered concomitantly Digoxin Enalapril Iron Metoprolol Warfarin Oral drugs that have demonstrated interaction with sevelamer and are to be dosed separately from sevelamer carbonate Ciprofloxacin Mycophenolate mofetil Dosing Recommendations Take at least 2 hours before or 6 hours after sevelamer Take at least 2 hours before sevelamer For oral medication where a reduction in the bioavailability of that medication would have a clinically significant effect on its safety or efficacy consider separation of the timing of administration and/or monitor clinical responses or blood levels of the concomitant medication.

( 7 ) Sevelamer did not alter the pharmacokinetics of digoxin, enalapril, iron, metoprolol and warfarin. (7) Sevelamer has demonstrated interaction with ciprofloxacin, mycophenolate mofetil, and therefore these drugs should be dosed separately from sevelamer carbonate. (7) Pediatric use information is approved for Genzyme Corporation’s Renvela (sevelamer carbonate) tablets and Renvela (sevelamer carbonate) for oral suspension.

However, due to Genzyme Corporation’s marketing exclusivity rights, these drug products are not labeled with that pediatric information.

👥 Use in Specific Populations ~2 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary Sevelamer carbonate is not absorbed systemically following oral administration and maternal use is not expected to result in fetal exposure to the drug. Clinical Considerations Sevelamer carbonate may decrease serum levels of fat soluble vitamins and folic acid in pregnant women [see Clinical Pharmacology (12.2 )] . Consider supplementation.

Data Animal Data In pregnant rats given dietary doses of 0.5, 1.5 or 4.5 g/kg/day of sevelamer hydrochloride during organogenesis, reduced or irregular ossification of fetal bones, probably due to a reduced absorption of fat-soluble vitamin D, occurred in mid- and high-dose groups (human equivalent doses approximately equal to 3 to 4 times the maximum clinical trial dose of 13 g). In pregnant rabbits given oral doses of 100, 500 or 1,000 mg/kg/day of sevelamer hydrochloride by gavage during organogenesis, an increase of early resorptions occurred in the high-dose group (human equivalent dose twice the maximum clinical trial dose).

8.2Lactation Risk Summary Sevelamer carbonate is not absorbed systemically by the mother following oral administration, and breastfeeding is not expected to result in exposure of the child to sevelamer carbonate. Clinical Considerations Sevelamer carbonate may decrease serum levels of fat soluble vitamins and folic acid in pregnant women [see Clinical Pharmacology (12.2) ] . Consider supplementation.

8.4Pediatric Use Sevelamer carbonate has not been studied in pediatric patients below 6 years of age. Pediatric use information is approved for Genzyme Corporation’s Renvela (sevelamer carbonate) tablets and Renvela (sevelamer carbonate) for oral suspension. However, due to Genzyme Corporation’s marketing exclusivity rights, these drug products are not labeled with that pediatric information.

8.5Geriatric Use Clinical studies of sevelamer carbonate did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range.

🤰 Pregnancy 152 words ▾

8.1Pregnancy Risk Summary Sevelamer carbonate is not absorbed systemically following oral administration and maternal use is not expected to result in fetal exposure to the drug. Clinical Considerations Sevelamer carbonate may decrease serum levels of fat soluble vitamins and folic acid in pregnant women [see Clinical Pharmacology (12.2 )] . Consider supplementation.

Data Animal Data In pregnant rats given dietary doses of 0.5, 1.5 or 4.5 g/kg/day of sevelamer hydrochloride during organogenesis, reduced or irregular ossification of fetal bones, probably due to a reduced absorption of fat-soluble vitamin D, occurred in mid- and high-dose groups (human equivalent doses approximately equal to 3 to 4 times the maximum clinical trial dose of 13 g). In pregnant rabbits given oral doses of 100, 500 or 1,000 mg/kg/day of sevelamer hydrochloride by gavage during organogenesis, an increase of early resorptions occurred in the high-dose group (human equivalent dose twice the maximum clinical trial dose).

🧒 Pediatric Use 54 words ▾

8.4Pediatric Use Sevelamer carbonate has not been studied in pediatric patients below 6 years of age. Pediatric use information is approved for Genzyme Corporation’s Renvela (sevelamer carbonate) tablets and Renvela (sevelamer carbonate) for oral suspension. However, due to Genzyme Corporation’s marketing exclusivity rights, these drug products are not labeled with that pediatric information.

🧓 Geriatric Use 65 words ▾

8.5Geriatric Use Clinical studies of sevelamer carbonate did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range.

🆘 Overdosage 49 words ▾

10 OVERDOSAGE In CKD patients on dialysis, the maximum dose studied was 14 grams of sevelamer carbonate and 13 grams of sevelamer hydrochloride. There are no reports of overdosage with sevelamer carbonate or sevelamer hydrochloride in patients. Since sevelamer is not absorbed, the risk of systemic toxicity is low.

🧬 Clinical Pharmacology ~2 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Sevelamer carbonate tablets contain sevelamer carbonate, a non-absorbed phosphate binding crosslinked polymer, free of metal and calcium. It contains multiple amines separated by one carbon from the polymer backbone. These amines exist in a protonated form in the intestine and interact with phosphate molecules through ionic and hydrogen bonding.

By binding phosphate in the gastrointestinal tract and decreasing absorption, sevelamer carbonate lowers the phosphate concentration in the serum (serum phosphorus).

12.2Pharmacodynamics In addition to effects on serum phosphorus levels, sevelamer hydrochloride has been shown to bind bile acids in vitro and in vivo in experimental animal models. Because sevelamer binds bile acids, it may interfere with normal fat absorption and thus may reduce absorption of fat soluble vitamins such as A, D and K. In clinical trials of sevelamer hydrochloride, both the mean total and LDL cholesterol declined by 15 to 31%; the clinical significance of this finding, which was observed after 2 weeks, is unclear.

Triglycerides, HDL cholesterol and albumin did not change.

12.3Pharmacokinetics A mass balance study using 14 C-sevelamer hydrochloride, in 16 healthy male and female volunteers showed that sevelamer hydrochloride is not systemically absorbed. No absorption studies have been performed in patients with renal disease. Drug Interactions In vivo Sevelamer carbonate has been studied in human drug-drug interaction studies (9.6 grams once daily with a meal) with warfarin and digoxin.

Sevelamer hydrochloride, which contains the same active moiety as sevelamer carbonate, has been studied in human drug-drug interaction studies (2.4 to 2.8 grams single dose or three times daily with meals or two times daily without meals) with ciprofloxacin, digoxin, enalapril, iron, metoprolol, mycophenolate mofetil and warfarin. Co-administered single dose of 2.8 grams of sevelamer hydrochloride in fasted state decreased the bioavailability of ciprofloxacin by approximately 50% in healthy subjects. Concomitant administration of sevelamer and mycophenolate mofetil in adult and pediatric patients decreased the mean MPA C max and AUC 0-12h by 36% and 26% respectively.

Sevelamer carbonate or sevelamer hydrochloride did not alter the pharmacokinetics of enalapril, digoxin, iron, metoprolol and warfarin when co-administered. During postmarketing experience, cases of increased thyroid stimulating hormone (TSH) levels have been reported in patients co-administered sevelamer hydrochloride and levothyroxine. Reduction in concentrations of cyclosporine and tacrolimus leading to dose increases has also been reported in transplant patients when co-administered with sevelamer hydrochloride without any clinical consequences (for example, graft rejection).

The possibility of an interaction cannot be excluded with these drugs.

🧬 Mechanism of Action 74 words ▾

12.1Mechanism of Action Sevelamer carbonate tablets contain sevelamer carbonate, a non-absorbed phosphate binding crosslinked polymer, free of metal and calcium. It contains multiple amines separated by one carbon from the polymer backbone. These amines exist in a protonated form in the intestine and interact with phosphate molecules through ionic and hydrogen bonding.

By binding phosphate in the gastrointestinal tract and decreasing absorption, sevelamer carbonate lowers the phosphate concentration in the serum (serum phosphorus).

📦 How Supplied / Storage and Handling 101 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Sevelamer Carbonate Tablets, 800 mg are supplied as white to off-white, oval shaped, film-coated tablets, imprinted with “J 75” on one side with edible black ink and plain on other side, containing 800 mg of sevelamer carbonate on an anhydrous basis, acetylated monoglycerides, ammonium hydroxide, black iron oxide, colloidal silicon dioxide, crospovidone, glyceryl behenate, hydroxypropyl cellulose, hypromellose, mannitol, propylene glycol, shellac glaze and talc. NDC 17856-0921-01 SEVELAMER CARBONATE 800 MG TAB 100 ct UD Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Dispense in a tight container. Protect from moisture.

📋 Description 155 words ▾

11 DESCRIPTION The active ingredient in sevelamer carbonate tablets is sevelamer carbonate, a polymeric amine that binds phosphate and is meant for oral administration. It was developed as a pharmaceutical alternative to sevelamer hydrochloride (Renagel ® ). Sevelamer carbonate is an anion exchange resin, with the same polymeric structure as sevelamer hydrochloride, in which carbonate replaces chloride as the counterion.

While the counterions differ for the two salts, the polymer itself, the active moiety involved in phosphate binding, is the same. Sevelamer carbonate is known chemically as poly(allylamine- co -N,N’-diallyl-1,3-diamino-2-hydroxypropane) carbonate salt. Sevelamer carbonate is hygroscopic, but insoluble in water.

The structure is represented in Figure 1. Sevelamer Carbonate Tablets: Each film-coated tablet of sevelamer carbonate contains 800 mg of sevelamer carbonate on an anhydrous basis. The inactive ingredients are acetylated monoglycerides, ammonium hydroxide, black iron oxide, colloidal silicon dioxide, crospovidone, glyceryl behenate, hydroxypropyl cellulose, hypromellose, mannitol, propylene glycol, shellac glaze and talc.

Chemical Structure

💬 Information for Patients 110 words ▾

17 PATIENT COUNSELING INFORMATION Inform patients to take sevelamer carbonate tablets with meals and adhere to their prescribed diets. For patients using an oral medication where a reduction in the bioavailability of that medication would have a clinically significant effect on its safety or efficacy, advise the patient to take the oral medication at least one hour before or three hours after sevelamer carbonate tablets. Advise patients to report new onset or worsening of existing constipation promptly to their physician.

The brands listed are trademarks of their respective owners and are not trademarks of Aurobindo Pharma Limited. Distributed by: ATLANTIC BIOLOGICALS CORP. 20101 N.E 16 th PLACE MIAMI, FL 33179

🧬 Pharmacokinetics ~1 min read ▾

12.3Pharmacokinetics A mass balance study using 14 C-sevelamer hydrochloride, in 16 healthy male and female volunteers showed that sevelamer hydrochloride is not systemically absorbed. No absorption studies have been performed in patients with renal disease. Drug Interactions In vivo Sevelamer carbonate has been studied in human drug-drug interaction studies (9.6 grams once daily with a meal) with warfarin and digoxin.

Sevelamer hydrochloride, which contains the same active moiety as sevelamer carbonate, has been studied in human drug-drug interaction studies (2.4 to 2.8 grams single dose or three times daily with meals or two times daily without meals) with ciprofloxacin, digoxin, enalapril, iron, metoprolol, mycophenolate mofetil and warfarin. Co-administered single dose of 2.8 grams of sevelamer hydrochloride in fasted state decreased the bioavailability of ciprofloxacin by approximately 50% in healthy subjects. Concomitant administration of sevelamer and mycophenolate mofetil in adult and pediatric patients decreased the mean MPA C max and AUC 0-12h by 36% and 26% respectively.

Sevelamer carbonate or sevelamer hydrochloride did not alter the pharmacokinetics of enalapril, digoxin, iron, metoprolol and warfarin when co-administered. During postmarketing experience, cases of increased thyroid stimulating hormone (TSH) levels have been reported in patients co-administered sevelamer hydrochloride and levothyroxine. Reduction in concentrations of cyclosporine and tacrolimus leading to dose increases has also been reported in transplant patients when co-administered with sevelamer hydrochloride without any clinical consequences (for example, graft rejection).

The possibility of an interaction cannot be excluded with these drugs.

🧬 Pharmacodynamics 95 words ▾

12.2Pharmacodynamics In addition to effects on serum phosphorus levels, sevelamer hydrochloride has been shown to bind bile acids in vitro and in vivo in experimental animal models. Because sevelamer binds bile acids, it may interfere with normal fat absorption and thus may reduce absorption of fat soluble vitamins such as A, D and K. In clinical trials of sevelamer hydrochloride, both the mean total and LDL cholesterol declined by 15 to 31%; the clinical significance of this finding, which was observed after 2 weeks, is unclear.

Triglycerides, HDL cholesterol and albumin did not change.

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES The ability of sevelamer to control serum phosphorus in CKD patients on dialysis was predominantly determined from the effects of the hydrochloride salt to bind phosphate. Six clinical trials used sevelamer hydrochloride and three clinical trials used sevelamer carbonate. The sevelamer hydrochloride studies include one double-blind, placebo-controlled 2-week study (sevelamer N=24); two open-label, uncontrolled, 8-week studies (sevelamer N=220) and three active-controlled open-label studies with treatment durations of 8 to 52 weeks (sevelamer N=256).

The sevelamer carbonate studies include one double-blind, active-controlled, cross-over study with two 8-week treatment periods using sevelamer carbonate tablets (N=79), one open-label, active-controlled, cross-over study with two 4-week treatment periods using sevelamer carbonate powder (N=31) and one randomized, parallel, open-label study using sevelamer carbonate powder (N=144) dosed once daily or sevelamer hydrochloride (Renagel ® ) tablets (N=73) dosed three times daily for 24 weeks. Six of the active-controlled studies are described here (three sevelamer carbonate and three sevelamer hydrochloride studies).

14.1Cross-Over Study of Sevelamer Carbonate 800 mg Tablets and Sevelamer Hydrochloride (Renagel ® ) 800 mg Tablets Stage 5 CKD patients on hemodialysis were entered into a five-week sevelamer hydrochloride run-in period and 79 patients received, in random order, sevelamer carbonate 800 mg tablets and sevelamer hydrochloride (Renagel ® ) 800 mg tablets for eight weeks each, with no intervening washout. Study dose during the cross-over period was determined based on the sevelamer hydrochloride dose during the run-in period on a gram per gram basis.

The phosphorus levels at the end of each of the two cross-over periods were similar. Average actual daily dose was 6 g/day divided among meals for both treatments. Thirty-nine of those completing the cross-over portion of the study were entered into a two-week washout period during which patients were instructed not to take any phosphate binders; this confirmed the activity of sevelamer in this study.

Pediatric use information is approved for Genzyme Corporation’s Renvela (sevelamer carbonate) tablets and Renvela (sevelamer carbonate) for oral suspension. However, due to Genzyme Corporation’s marketing exclusivity rights, these drug products are not labeled with that pediatric information.

14.4Sevelamer Hydrochloride Versus Active-Control, Cross-Over Study in Hemodialysis Patients Eighty-four CKD patients on hemodialysis who were hyperphosphatemic (serum phosphorus > 6.0 mg/dL) following a two-week phosphate binder washout period were randomized in a cross-over design to receive in random order sevelamer hydrochloride and active-control for eight weeks each. Treatment periods were separated by a two-week phosphate binder washout period. Patients started on treatment three times per day with meals.

Over each eight-week treatment period, at three separate time points the dose of sevelamer hydrochloride could be titrated up to control serum phosphorus, the dose of active-control could also be altered to attain phosphorus control. Both treatments significantly decreased mean serum phosphorus by about 2 mg/dL (Table 6). Table 6.

Mean Serum Phosphorus (mg/dL) at Baseline and Endpoint *p<0.0001, within treatment group comparison Sevelamer Hydrochloride (N=81) Active Control (N=83) Baseline at End of Washout 8.4

8.0Endpoint 6.4

5.9Change from Baseline at Endpoint (95% Confidence Interval) -2.0* (-2.5, -1.5) -2.1* (-2.6, -1.7) The distribution of responses is shown in Figure 3. The distributions are similar for sevelamer hydrochloride and active control. The median response is a reduction of about 2 mg/dL in both groups.

About 50% of subjects have reductions between 1 and 3 mg/dL. Average daily sevelamer hydrochloride dose at the end of treatment was 4.9 g (range of 0 to 12.6 g). image description

14.5Sevelamer Hyd… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology 196 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Standard lifetime carcinogenicity bioassays were conducted in mice and rats. Rats were given sevelamer hydrochloride by diet at 0.3, 1, or 3 g/kg/day. There was an increased incidence of urinary bladder transitional cell papilloma in male rats of the high dose group (human equivalent dose twice the maximum clinical trial dose of 13 g).

Mice received dietary administration of sevelamer hydrochloride at doses of up to 9 g/kg/day (human equivalent dose 3 times the maximum clinical trial dose). There was no increased incidence of tumors observed in mice. In an in vitro mammalian cytogenetic test with metabolic activation, sevelamer hydrochloride caused a statistically significant increase in the number of structural chromosome aberrations.

Sevelamer hydrochloride was not mutagenic in the Ames bacterial mutation assay. Sevelamer hydrochloride did not impair the fertility of male or female rats in a dietary administration study in which the females were treated from 14 days prior to mating through gestation and the males were treated for 28 days prior to mating. The highest dose in this study was 4.5 g/kg/day (human equivalent dose 3 times the maximum clinical trial dose of 13 g).

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 193 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Standard lifetime carcinogenicity bioassays were conducted in mice and rats. Rats were given sevelamer hydrochloride by diet at 0.3, 1, or 3 g/kg/day. There was an increased incidence of urinary bladder transitional cell papilloma in male rats of the high dose group (human equivalent dose twice the maximum clinical trial dose of 13 g).

Mice received dietary administration of sevelamer hydrochloride at doses of up to 9 g/kg/day (human equivalent dose 3 times the maximum clinical trial dose). There was no increased incidence of tumors observed in mice. In an in vitro mammalian cytogenetic test with metabolic activation, sevelamer hydrochloride caused a statistically significant increase in the number of structural chromosome aberrations.

Sevelamer hydrochloride was not mutagenic in the Ames bacterial mutation assay. Sevelamer hydrochloride did not impair the fertility of male or female rats in a dietary administration study in which the females were treated from 14 days prior to mating through gestation and the males were treated for 28 days prior to mating. The highest dose in this study was 4.5 g/kg/day (human equivalent dose 3 times the maximum clinical trial dose of 13 g).

📄 Recent Major Changes 13 words ▾

Indications and Usage (1) 11/2016 Dosage and Administration (2) 11/2016 Contraindications (4) 03/2016

📄 Package Label / Principal Display Panel 11 words ▾

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 800 mg (30 Tablets Bottle) 1

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Sevelamer Carbonate — the program that covers self-administered drugs. 10 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Sevelamer Carbonate. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$892.5K
Claims incl. refills
10.8K
Beneficiaries
6.3K
Spend / beneficiary
$141.12
Spend / claim
$82.77
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for SEVELAMER CARBONATE — the ingredient across all brands.

Top reported reactions

Constipation2,547
Diarrhoea1,045
Pruritus1,009
Nausea816
Chronic Kidney Disease676
End Stage Renal Disease672
Renal Failure664

Age at onset

Infant4
Child28
Adolescent10
Adult4,414
Elderly777

Reporter sex

11,427 reports
Male · 48%
Female · 44%
Unknown · 8%

Serious outcomes

Hospitalization3,028
Death1,217
Life-threatening236
Disabling157
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 790 133
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by ATLANTIC BIOLOGICALS CORP.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
ATLANTIC BIOLOGICALS CORP. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 17856-0874-03 · Atlantic 17856-0922-01 · ATLANTIC →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.