Sevelamer Carbonate 800 mg Tablet, Film Coated, 270-count — NDC 71205-966-67 (Billing 71205-0966-67)
This is a package of 270 tablets of Sevelamer Carbonate 800 mg Tablet, Film Coated from Proficient Rx LP, marketed since Sep 2019 and currently FDA-listed, this package's marketing is listed to end Nov 2027. It is this product's only package size.
NDC database record
One package, one record: these facts belong to NDC 71205-966-67 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 71205 labeler · 966 product · 67 package
- Package marketed since
- Jun 9, 2020
- Package marketing ended
- Nov 30, 2027
- Sample package
- No — commercial package
- Billing quantity
- 270 EA per package
- Barcode (UPC)
- 0371205966676
- FDA record last changed
- Jul 24, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 063473
- GCN: 99200
- GPI-14 (Medi-Span): 52800070050340
- HICL (First Databank): 035262
- AHFS class code: 40:18.19.00
- RxCUI (RxNorm): 749206
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
RxNorm drug class
This medicine belongs to the Phosphate Binder class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
- 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...
Patient education
Supplement & herbal interactions
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
Ask a licensed pharmacist directly — free, answered by our team.
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 system | Per each | Per 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 | $96.77 / 270 tablets |
Where does this data come from?
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · refreshed Oct 3, 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 71205-0966-67 You're viewing this Main listing | 270 TABLET, FILM COATED in 1 BOTTLE | 2020-06-09 | Nov 30, 2027 | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price 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 mg 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 mgthis 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 | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file
Availability & generic status
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?
- FDA Orange Book · refreshed Oct 3, 2026
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.
Where does this data come from?
IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.- FDA label on DailyMed · label index refreshed Oct 1, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
More NDCs from Proficient Rx LP labeler code 71205
- Guanfacine Extended-Release 4 mg Tablet, Extended Release NDC 71205-947-00
- Donepezil Hydrochloride 23 mg Tablet, Film Coated NDC 71205-948-00
- Fenofibrate 160 mg Tablet, Film Coated NDC 71205-949-30
- Nifedipine 30 mg Tablet, Extended Release NDC 71205-963-00
- Nifedipine 60 mg Tablet, Extended Release NDC 71205-964-00
- Nifedipine 90 mg Tablet, Extended Release NDC 71205-965-00
- Bupropion Hydrochloride (XL) 150 mg Tablet, Extended Release NDC 71205-967-30
- Bupropion Hydrochloride (XL) 300 mg Tablet, Extended Release NDC 71205-968-30
- Senna-S Sennosides 8.6mg and Docusate Sodium 50mg 8.6 mg; 50 mg Tablet, Film Coated NDC 71205-970-00
- benzonatate 100 mg Capsule NDC 71205-971-00
- benzonatate 200 mg Capsule NDC 71205-972-00
- Lidocaine hydrochloride 30 mg/g Cream NDC 71205-973-01
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
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 DOSAGE AND ADMINISTRATION • Starting dose of sevelamer carbonate is 0.8 or 1.6 grams administered orally three times per day with meals based on serum phosphorus levels for adult patients. ( Error! Hyperlink reference not valid. ) • Titrate by 0.8 g per meal in two week intervals for adult patients as needed to obtain serum phosphorus target. ( Error! Hyperlink reference not valid. )
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 > 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 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 Tablets For adult patients switching from sevelamer hydrochloride 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 2. Starting Dose for Dialysis Patients Switching From Calcium Acetate to Sevelamer Carbonate Tablets Calcium Acetate 667 mg (Tablets per meal) Sevelamer Carbonate 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 ▾
3 DOSAGE FORMS AND STRENGTHS Tablets: 0.8 g white oval, film-coated, compressed tablets imprinted with "T186" • Tablets: 0.8 g ( 3 )
⛔ Contraindications ▾
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 ▾
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 carbonate for oral 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 to10 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 ▾
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 TWi Pharmaceuticals, Inc. at 1-844-518-2989 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 tablets. 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 for oral suspension 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 ▾
7 DRUG INTERACTIONS There are no empirical data on avoiding drug interactions between sevelamer carbonate tablets 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 3. 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 tablets 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 tablets. ( 7 )
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.
👥 Use in Specific Populations ▾
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 1000 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 tablets are not absorbed systemically by the mother following oral administration, and breastfeeding is not expected to result in exposure of the child to sevelamer carbonate tablets. 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 tablets 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 ▾
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 1000 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 ▾
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 ▾
8.5Geriatric Use Clinical studies of sevelamer carbonate tablets 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 ▾
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 ▾
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 ▾
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 ▾
16 HOW SUPPLIED/STORAGE AND HANDLING Sevelamer carbonate tablets, for oral administration, are available as: 800 mg: off white, modified oval tablet core, imprinted "T186" on one side and plain on the reverse side, film coated white,and supplied as: Bottles of 270 tablets (NDC 71205-966-67) Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from moisture. Dispense in a tight container.
📦 Storage and Handling ▾
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from moisture. Dispense in a tight container.
📋 Description ▾
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. 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 tablets are 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 Error! Hyperlink reference not valid. : Figure 1. Chemical Structure of Sevelamer Carbonate Sevelamer carbonate tablets: Each film-coated tablet of sevelamer carbonate tablets contains 800 mg of sevelamer carbonate on an anhydrous basis.
The inactive ingredients are carnauba wax, hypromellose, hydroxypropyl cellulose, microcrystalline cellulose, polyethylene glycol, sodium chloride, titanium dioxide, and zinc stearate. The tablet imprint contains black iron oxide, propylene glycol and hypromellose. Sevelamer Carbonate Chemical Structure
💬 Information for Patients ▾
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. Advise patients to report new onset or worsening of existing constipation promptly to their physician.
The brands listed are the registered trademarks of their respective owners and are not trademarks of Sandoz Inc. Revised: June 2019 Manufactured for: TWi Pharmaceuticals USA, Inc. Paramus, NJ 07652 Manufactured by: TWi Pharmaceuticals, Inc.
Taoyuan City, 32063, Taiwan Relabeled by: Proficient Rx LP Thousand Oaks, CA 91320 TWi
🧬 Pharmacokinetics ▾
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 ▾
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 ▾
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 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 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 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.
14.2Cross-Over Study of Sevelamer Carbonate Powder and Sevelamer Hydrochloride Tablets Stage 5 CKD patients on hemodialysis were entered into a four-week sevelamer hydrochloride run-in period and 31 patients received, in random order, sevelamer carbonate powder and sevelamer hydrochloride tablets for four 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 sevelamer carbonate for oral suspension and 6.4 g/day divided among meals for sevelamer hydrochloride tablets. 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… [Excerpted — this section continues on DailyMed.]
🧪 Nonclinical Toxicology ▾
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 ▾
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 ▾
Indications and Usage ( 1 ) Dosage and Administration ( 2 ) Contraindications ( 4 ) 11/2016 11/2016 03/2016
📄 Package Label / Principal Display Panel ▾
800 mg Label NDC 71205-966-67 Sevelamer Carbonate Tablets 800 mg Rx only 270 Tablets 71205-966-67
Medicare Part D spend CMS · PART D · 2026 (Q1)
Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
Where does this data come from?
About this NDC listing & data coverage
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. |