NDC 60687-449 Sevelamer Hydrochloride

Sevelamer Hydrochloride

NDC Product Code 60687-449

NDC CODE: 60687-449

Proprietary Name: Sevelamer Hydrochloride What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Sevelamer Hydrochloride What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Product Characteristics

Shape: OVAL (C48345)
19 MM
Score: 1

NDC Code Structure

  • 60687 - American Health Packaging

NDC 60687-449-01

Package Description: 100 BLISTER PACK in 1 BOX, UNIT-DOSE > 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-449-11)

NDC Product Information

Sevelamer Hydrochloride with NDC 60687-449 is a a human prescription drug product labeled by American Health Packaging. The generic name of Sevelamer Hydrochloride is sevelamer hydrochloride. The product's dosage form is tablet, film coated and is administered via oral form.

Labeler Name: American Health Packaging

Dosage Form: Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.

Product Type: Human Prescription Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Sevelamer Hydrochloride Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.


Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • HYPROMELLOSE 2910 (50 MPA.S) (UNII: 1IVH67816N)
  • AMMONIA (UNII: 5138Q19F1X)
  • SHELLAC (UNII: 46N107B71O)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Phosphate Binder - [EPC] (Established Pharmacologic Class)
  • Phosphate Chelating Activity - [MoA] (Mechanism of Action)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: American Health Packaging
Labeler Code: 60687
FDA Application Number: ANDA204724 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: ANDA - A product marketed under an approved Abbreviated New Drug Application. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 10-01-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N - NO What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Information for Patients


Sevelamer is pronounced as (se vel' a mer)

Why is sevelamer medication prescribed?
Sevelamer is used to control high blood levels of phosphorus in people with chronic kidney disease who are on dialysis (medical treatment to clean the blood when the kidn...
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* Please review the disclaimer below.

Sevelamer Hydrochloride Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

1. Indications And Usage

Sevelamer hydrochloride tablets are indicated for the control of serum phosphorus in patients with chronic kidney disease (CKD) on dialysis. The safety and efficacy of sevelamer hydrochloride tablets in CKD patients who are not on dialysis have not been studied.

2. Dosage And Administration

Patients Not Taking a Phosphate Binder. The recommended starting dose of sevelamer hydrochloride tablets is 800 to 1600 mg, which can be administered as one or two 800 mg sevelamer hydrochloride tablets or two to four 400 mg sevelamer hydrochloride tablets, with meals based on serum phosphorus level. Table 1 provides recommended starting doses of sevelamer hydrochloride tablets for patients not taking a phosphate binder.

Table 1: Starting Dose for Dialysis Patients Not Taking a Phosphate BinderSerum PhosphorusSevelamer Hydrochloride Tablets 800 mgSevelamer Hydrochloride Tablets 400 mg> 5.5 and < 7.5 mg/dL1 tablet three times daily with meals2 tablets three times daily with meals≥ 7.5 and < 9 mg/dL2 tablets three times daily with meals3 tablets three times daily with meals≥ 9 mg/dL2 tablets three times daily with meals4 tablets three times daily with mealsPatients Switching from Calcium Acetate. In a study in 84 CKD patients on hemodialysis, a similar reduction in serum phosphorus was seen with equivalent doses (approximately mg for mg) of sevelamer hydrochloride tablets and calcium acetate. Table 2 gives recommended starting doses of sevelamer hydrochloride tablets based on a patient’s current calcium acetate dose.

Table 2: Starting Dose for Dialysis Patients Switching From Calcium Acetate to Sevelamer Hydrochloride TabletsCalcium Acetate 667 mg (Tablets per meal)Sevelamer Hydrochloride Tablets 800 mg(Tablets per meal)Sevelamer Hydrochloride Tablets 400 mg(Tablets per meal)1 tablet1 tablet2 tablets2 tablets2 tablets3 tablets3 tablets3 tablets5 tabletsDose Titration for All Patients Taking Sevelamer Hydrochloride Tablets. Dosage should be adjusted based on the serum phosphorus concentration with a goal of lowering serum phosphorus to 5.5 mg/dL or less. The dose may be increased or decreased by one tablet per meal at two-week intervals as necessary. Table 3 gives a dose titration guideline. The average dose in a Phase 3 trial designed to lower serum phosphorus to 5 mg/dL or less was approximately three sevelamer hydrochloride 800 mg tablets per meal. The maximum average daily sevelamer hydrochloride tablets dose studied was 13 g.

Table 3: Dose Titration GuidelineSerum PhosphorusSevelamer Hydrochloride Tablets Dose>5.5 mg/dLIncrease 1 tablet per meal at 2-week intervals3.5 to 5.5 mg/dLMaintain current dose<3.5 mg/dLDecrease 1 tablet per meal

3. Dosage Forms And Strengths

800 mg and 400 mg Tablets.

4. Contraindications

Sevelamer hydrochloride is contraindicated in patients with bowel obstruction.Sevelamer hydrochloride tablets are contraindicated in patients with known hypersensitivity to sevelamer hydrochloride or to any of the excipients.

5.1 Gastrointestinal 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 hydrochloride clinical studies.

5.2 Monitor Serum Chemistries

Bicarbonate and chloride levels should be monitored.

5.3 Monitor For Reduced Vitamins D, E, K (Clotting Factors) And Folic Acid Levels

In preclinical studies in rats and dogs, sevelamer hydrochloride 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 received vitamin supplements, which is typical of patients on dialysis.

6.1 Clinical 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.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-control 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 one hundred and forty-three peritoneal dialysis patients studied for 12 weeks, most 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. Patients on peritoneal dialysis should be closely monitored to ensure the reliable use of appropriate aseptic technique with the prompt recognition and management of any signs and symptoms associated with peritonitis.

6.2 Postmarketing Experience

The following adverse reactions have been identified during post-approval use of sevelamer hydrochloride: 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.Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency or to establish a causal relationship to drug exposure.

7. Drug Interactions

There are no empirical data on avoiding drug interactions between sevelamer hydrochloride 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 (


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 monitor clinical responses or blood levels of concomitant drugs that have a narrow therapeutic range.

Table 4: Sevelamer Drug InteractionsOral drugs for which sevelamer did not alter the pharmacokinetics when administered concomitantlyDigoxin





Oral drugs that have demonstrated interaction with sevelamer and are to be dosed separately from sevelamer hydrochlorideDosing RecommendationsCiprofloxacinTake at least 2 hours before or 6 hours after sevelamerMycophenolate mofetilTake at least 2 hours before sevelamer

8.1 Pregnancy

Pregnancy Category C: The effect of sevelamer hydrochloride on the absorption of vitamins and other nutrients has not been studied in pregnant women. Requirements for vitamins and other nutrients are increased in pregnancy. In pregnant rats given doses 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 pregnant rabbits given oral doses of sevelamer hydrochloride by gavage during organogenesis, an increase of early resorptions occurred.


8.2 Lactation

No sevelamer hydrochloride treatment-related effects on labor and delivery were seen in animal studies. The effects of sevelamer hydrochloride on labor and delivery in humans are not known.


8.4 Pediatric Use

The safety and efficacy of sevelamer hydrochloride has not been established in pediatric patients.

8.5 Geriatric Use

Clinical studies of sevelamer hydrochloride 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.

10. Overdosage

Sevelamer hydrochloride has been given to normal healthy volunteers in doses of up to 14 g per day for eight days with no adverse effects. Sevelamer hydrochloride has been given in average doses up to 13 g per day to hemodialysis patients. There are no reports of overdosage with sevelamer hydrochloride in patients. Since sevelamer hydrochloride is not absorbed, the risk of systemic toxicity is low.

11. Description

The active ingredient in Sevelamer Hydrochloride Tablets is sevelamer hydrochloride, a polymeric amine that binds phosphate and is meant for oral administration. Sevelamer hydrochloride is poly(allylamine hydrochloride) crosslinked with epichlorohydrin in which 40% of the amines are protonated. It is known chemically as poly(allylamine-

co-N,N'-diallyl-1,3-diamino-2-hydroxypropane) hydrochloride. Sevelamer hydrochloride is hydrophilic, but insoluble in water. The structure is represented in Figure 1.

Figure 1: Chemical Structure of Sevelamer Hydrochloridea, b = number of primary amine groups a + b = 9 c = number of crosslinking groups c = 1 n = fraction of protonated amines n = 0.4 m = large number to indicate extended polymer network The primary amine groups shown in the structure are derived directly from poly(allylamine hydrochloride). The crosslinking groups consist of two secondary amine groups derived from poly(allylamine hydrochloride) and one molecule of epichlorohydrin.Sevelamer Hydrochloride Tablets: Each film-coated tablet of sevelamer hydrochloride contains either 800 mg or 400 mg of sevelamer hydrochloride on an anhydrous basis. The inactive ingredients are colloidal silicon dioxide, corn starch, diacetylated monoglycerides, hypromellose, lactose monohydrate, mannitol, talc and zinc stearate. The imprinting ink for sevelamer hydrochloride tablets has the following components: black iron oxide, butyl alcohol, isopropyl alcohol, propylene glycol, ammonium hydroxide and shellac.

12. Clinical Pharmacology

Patients with chronic kidney disease (CKD) on dialysis retain phosphorus and can develop hyperphosphatemia. High serum phosphorus can precipitate serum calcium resulting in ectopic calcification. When the product of serum calcium and phosphorus concentrations (Ca × P) exceeds 55 mg


2, there is an increased risk that ectopic calcification will occur. Hyperphosphatemia plays a role in the development of secondary hyperparathyroidism in renal insufficiency.

Treatment of hyperphosphatemia includes reduction in dietary intake of phosphate, inhibition of intestinal phosphate absorption with phosphate binders, and removal of phosphate with dialysis. Sevelamer hydrochloride taken with meals has been shown to decrease serum phosphorus concentrations in patients with CKD who are on dialysis.

12.1 Mechanism Of Action

Sevelamer hydrochloride tablets contain sevelamer hydrochloride, a non-absorbed binding crosslinked polymer. 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 dietary tract and decreasing absorption, sevelamer hydrochloride lowers the phosphate concentration in the serum.

12.2 Pharmacodynamics

In addition to effects on serum phosphate levels, sevelamer hydrochloride has been shown to bind bile acids

in vitro and

in vivo in experimental animal models. Bile acid binding by ion exchange resins is a well-established method of lowering blood cholesterol. 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%. This effect is observed after 2 weeks. Triglycerides, HDL cholesterol, and albumin did not change.

12.3 Pharmacokinetics

A mass balance study using

14C-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 g 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 g single dose or three times daily with meals or two times daily without meals) with ciprofloxacin, digoxin, enalapril, iron, metoprolol, mycophenolate mofetil and warfarin.

Coadministered single dose of 2.8 g 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 to 12h by 36% and 26% respectively.

Sevelamer carbonate or sevelamer hydrochloride did not alter the pharmacokinetics of a single dose of enalapril, digoxin, iron, metoprolol and warfarin when coadministered.During postmarketing experience, cases of increased thyroid stimulating hormone (TSH) levels have been reported in patients coadministered sevelamer hydrochloride and levothyroxine. Reduction in concentrations of cyclosporine and tacrolimus leading to dose increases has also been reported in transplant patients when coadministered with sevelamer hydrochloride without any clinical consequences (e.g., graft rejection). The possibility of an interaction cannot be excluded with these drugs.

13.1 Carcinogenesis, 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).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 less than 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).

14. Clinical Studies

The ability of sevelamer hydrochloride to lower serum phosphorus in CKD patients on dialysis was demonstrated in six clinical trials: one double-blind placebo-controlled 2-week study (sevelamer hydrochloride N=24); two open-label uncontrolled 8-week studies (sevelamer hydrochloride N=220) and three active-controlled open-label studies with treatment durations of 8 to 52 weeks (sevelamer hydrochloride N=256). Three of the active-controlled studies are described here. One is a crossover study with two 8-week periods comparing sevelamer hydrochloride to an active control. The second is a 52-week parallel study comparing sevelamer hydrochloride with active control. The third is a 12-week parallel study comparing sevelamer hydrochloride and active-control in peritoneal dialysis patients.

14.1 Active-Control, Cross-Over Study In Hemodialysis Patients

Eighty-four CKD patients on hemodialysis who were hyperphosphatemic (serum phosphorus > 6 mg/dL) following a two-week phosphate binder washout period received sevelamer hydrochloride and active-control for eight weeks each in random order. 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 1 capsule or tablet per meal (3 per day) to control serum phosphorus, the dose of active-control could also be altered to attain phosphate control. Both treatments significantly decreased mean serum phosphorus by about 2 mg/dL (Table 5).Table 5: Mean Serum Phosphorus (mg/dL) at Baseline and EndpointSevelamer Hydrochloride Tablets(N=81)Active-Control(N=83)Baseline at End of Washout8.48Endpoint6.45.9Change from Baseline at Endpoint(95% Confidence Interval)-2

p<0.0001, within treatment group comparison(-2.5, -1.5)-2.1

(-2.6, -1.7)The distribution of responses is shown in Figure 2. 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.Figure 2: Percentage of patients (Y-axis) attaining a phosphorus reduction from baseline (mg/dL) at least as great as the value of the X-axisAverage daily sevelamer hydrochloride dose at the end of treatment was 4.9 g (range of 0 to 12.6 g).

14.2 Active-Control, Parallel Study In Hemodialysis Patients

Two hundred CKD patients on hemodialysis who were hyperphosphatemic (serum phosphorus >5.5 mg/dL) following a two-week phosphate binder washout period were randomized to receive sevelamer hydrochloride 800 mg tablets (N=99) or an active-control (N=101). The two treatments produced similar decreases in serum phosphorus. At week 52, using last observation carried forward, sevelamer hydrochloride and active-control both significantly decreased mean serum phosphorus (Table 6).Table 6: Mean Serum Phosphorus (mg/dL) and Ion Product at Baseline and Change from Baseline to End of TreatmentSevelamer Hydrochloride TabletsActive-Control(N=94)(N=98)PhosphorusBaseline7.57.3Change from Baseline at Endpoint-2.1-1.8Ca x Phosphorus Ion ProductBaseline70.568.4Change from Baseline at Endpoint-19.4-14.2Sixty-one percent of sevelamer hydrochloride patients and 73% of the control patients completed the full 52 weeks of treatment.Figure 3, a plot of the phosphorus change from baseline for the completers, illustrates the durability of response for patients who are able to remain on treatment.Figure 3: Mean Phosphorus Change from Baseline for Patients who Completed 52 Weeks of TreatmentAverage daily sevelamer hydrochloride dose at the end of treatment was 6.5 g (range of 0.8 to 13 g).

14.3 Active-Control, Parallel Study In Peritoneal Dialysis Patients

One hundred and forty-three patients on peritoneal dialysis, who were hyperphosphatemic (serum phosphorus > 5.5 mg/dL) following a two-week phosphate binder washout period, were randomized to receive sevelamer hydrochloride (N=97) or active-control (N=46) open label for 12 weeks. Average daily sevelamer hydrochloride dose at the end of treatment was 5.9 g (range 0.8 to 14.3 g). There were statistically significant changes in serum phosphorus (p<0.001) for sevelamer hydrochloride (-1.6 mg/dL from baseline of 7.5 mg/dL), similar to the active-control.

16. How Supplied/Storage And Handling

Sevelamer Hydrochloride Tablets, 800 mg, are supplied as off-white to pale yellow, modified capsule shaped, biconvex film coated tablets, imprinted with ‘G447’ on one side and plain on the other side and are supplied as follows:

Unit dose packages of 100 (10 x 10) NDC 60687-449-01

Storage Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].

Do not use Sevelamer Hydrochloride Tablets after the expiration date.

Protect from moisture.FOR YOUR PROTECTION: Do not use if blister is torn or broken.

17 Patient Counseling Information

Dosing Recommendations
The prescriber should inform patients to take sevelamer hydrochloride tablets with meals and adhere to their prescribed diets. Instructions should be given on concomitant medications that should be dosed apart from sevelamer hydrochloride tablets.
Adverse Reactions
Sevelamer hydrochloride tablets may cause constipation that if left untreated, may lead to severe complications. Patients should be

cautioned to report new onset or worsening of existing constipation promptly to their physician.
Questions? 1 (888) 721-7115

Packaging Information

American Health Packaging unit dose blisters (see
How Supplied section) contain drug product from Glenmark Pharmaceuticals Inc., USA as follows:

(800 mg / 100 UD) NDC 60687-449-01 packaged from NDC 68462-447
Distributed by:
American Health Packaging
Columbus, OH 43217

Package/Label Display Panel – Carton – 800 Mg

NDC 60687-


800 mg100 Tablets (10 x 10)             Rx OnlyEach Film-Coated Tablet Contains:
Sevelamer hydrochloride ............................................800 mg
Usual Dosage: See package insert for full prescribing

Store at 20° to 25°C (68° to 77°F); excursions permitted

between 15° to 30°C (59° to 86°F) [see USP Controlled

Room Temperature]. Protect from moisture.
Keep this and all drugs out of reach of children.FOR YOUR PROTECTION: Do not use if blister is torn or

The drug product contained in this package is from

NDC # 68462-447, Glenmark Pharmaceuticals Inc., USA.
Packaged and Distributed by:

American Health Packaging

Columbus, Ohio 43217


Package/Label Display Panel – Blister – 800 Mg

Sevelamer Hydrochloride

800 mg

* Please review the disclaimer below.