Home › NDC Lookup › Ingredients › Sodium Polystyrene Sulfonate › 10135-0146-17
🧴image loading
(from DailyMed)

Sodium Polystyrene Sulfonate 4.1 meq/g Powder, For Suspension, 454 g — NDC 10135-146-17 (Billing 10135-0146-17)

by Marlex Pharmaceuticals Inc · 454 g in 1 JAR

This is a package of 454 g of Sodium Polystyrene Sulfonate 4.1 meq/g Powder, For Suspension from Marlex Pharmaceuticals Inc, no longer marketed, no longer in the FDA NDC Directory.

NDC 10135-0146-17
🏷️ FDA NDC (as labeled) 10135-146-17 billing pads the product segment with a zero
This package
Contains454 g Pack sizes2 compare ↓
Product page 10135-0146-14 Also comes in: 15 g 10135-146-14
Rx only Generic Discontinued Non-controlled ⚠ Inactivated by FDA ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Jul 17, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

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 10135-146-17 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
10135 labeler · 146 product · 17 package
Billing quantity
454 g per package
Barcode (UPC-A, from the NDC)
3 1013514617 8
FDA record last changed
Jul 17, 2026
⚠️
Excluded from the active FDA NDC Directory. FDA inactivated this product’s listing record, so it is excluded from the active NDC Directory. The listing was last certified through Dec 2025. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 10135-146-17
Product NDC 10135-146
11-digit billing NDC 10135014617
NCPDP billing unit GM — per gram (weight)
Application # ANDA204071
SPL Set ID 3423d014-4c35-441a-8528-2a7bc050f809
DEA schedule Non-controlled
Marketing category ANDA
Marketing status Discontinued
FDA listing status Inactivated by FDA (certified through Dec 2025)
Route ORAL; RECTAL
Dosage form POWDER, FOR SUSPENSION
Substance SODIUM POLYSTYRENE SULFONATE

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 99450010002900
GCN Seq No 001194
GCN 02890
HICL code 013209
Ingredient (HICL) Sodium Polystyrene Sulfonate
HIC1 code C
Therapeutic class — broad (HIC1) Electrolyte Balance/Metabolism/Nutrition
HIC2 code C1
Therapeutic class — intermediate (HIC2) Drugs Affecting Electrolyte Balance
HIC3 code C1A
Therapeutic class — specific (HIC3) Electrolyte Depleters
AHFS code 40:18.18.00
AHFS class Potassium-Removing Agents
FDB label name SODIUM POLYSTYRENE SULF POWDER
FDB brand name Sodium Polystyrene Sulfonate
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 001194
  • GCN: 02890
  • GPI-14 (Medi-Span): 99450010002900
  • HICL (First Databank): 013209
  • AHFS class code: 40:18.18.00
Why two NDCs? The FDA registers this code as 10135-146-17 — a 5-3-2 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 product segment → 10135-0146-17. 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.

Clinical

Label name SODIUM POLYSTYRENE SULF POWDER Ingredient Sodium Polystyrene Sulfonate
📗 Our plain-language guide HelloPharmacist
  • Think of it like a sponge that travels through your gut. It swaps out sodium for potassium along the way, grabbing extra potassium and carrying it out of your body in your stool. Y...
  • What exactly is this medicine doing to my body?
  • That's one of the most important things to understand about this medicine — it's slow. It can take anywhere from several hours to a couple of days to meaningfully lower your potass...
  • No — and this is really important. This resin can grab on to other medications in your stomach and prevent them from being absorbed properly. You need to take all your other oral m...
📖 Read our full Sodium Polystyrene Sulfonate 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 mLPer 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 · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 15 g
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
10135-0146-14 10135-146-14 Main listing 15 g in 1 BOTTLE, PLASTIC 2016-03-01 — Inactivated by FDA
10135-0146-17 You're viewing this 454 g in 1 JAR 2016-03-01 — Inactivated by FDA

You're viewing the largest of 2 pack sizes for this product.

Pack size FAQ

What quantity is in this package?
This package contains 454 g — 454 g in 1 jar.
How does this package differ from NDC 10135-0146-14?
Both are Sodium Polystyrene Sulfonate 4.1 meq/g Powder, For Suspension — the drug itself is identical. This page's package is the 454 g one, while NDC 10135-0146-14 is the 15 g package.
What NDC number is used to bill for this package of Sodium Polystyrene Sulfonate 4.1 meq/g Powder, For Suspension?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Sodium Polystyrene Sulfonate 1 g/g 46287-0012-16 CMP 454 g $0.092 AA Availability likely —
Sodium Polystyrene Sulfonate 4.1 meq/g 24658-0760-16 PuraCap 453.6 g $0.155 AA Availability likely —
Sodium Polystyrene Sulfonate 1 g/g 10702-0036-15 KVK-Tech, 15 g $0.474 AA Availability likely —
Sodium Polystyrene Sulfonate 4.1 meq/g 42806-0013-94 Epic 15 g $0.474 AA Availability likely —
Sodium Polystyrene Sulfonate 4.1 meq/g 11534-0166-15 SUNRISE 15 g $0.529 — FDA listed —
Sodium Polystyrene Sulfonate 4.1 meq/g 17856-0024-01 ATLANTIC 50 cups — AA FDA listed —
Sodium Polystyrene Sulfonate 4.1 meq/g 62135-0340-11 Chartwell 10 bottles — AA FDA listed —
Sodium Polystyrene Sulfonate 4.1 meq/g 63629-2390-01 Bryant 454 g — — FDA listed —
Sodium Polystyrene Sulfonate 4.1 meq/g 63629-8849-01 Bryant 15 g — — FDA listed —
Sodium Polystyrene Sulfonate 4.1 meq/g 63629-8850-01 Bryant 15 g — — FDA listed —
Sodium Polystyrene Sulfonate 4.1 meq/g 71335-2855-01 Bryant 15 g — — FDA listed —
Sodium Polystyrene Sulfonate 4.1 meq/g 72162-1230-02 Bryant 454 g — — FDA listed —
Sodium Polystyrene Sulfonate 4.1 meq/gthis 10135-0146-17 Marlex 454 g — — Discontinued —
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

📍
2026
Currently FDA-listed
listed with the FDA
🔓
·
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.

🧪 Avoiding an ingredient? See Sodium Polystyrene Sulfonate inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

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

LabelerMarlex Pharmaceuticals Inc
Application holderNUVO PHAMACEUTICALS INC
FDA applicationANDA204071 (ANDA)
Labeler code10135
Product typeHuman Prescription Drug
Portfolio30 products on file

More NDCs from Marlex Pharmaceuticals Inc labeler code 10135

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. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🔄 Drug Interactions 🤰 Pregnancy 🧒 Pediatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description ⚠️ Precautions 🍼 Nursing Mothers 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 15 words ▾

INDICATIONS AND USAGE Sodium polystyrene sulfonate for suspension is indicated for the treatment of hyperkalemia.

⏱️ Dosage and Administration ~3 min read ▾

DOSAGE AND ADMINISTRATION Suspension of this drug should be freshly prepared and not stored beyond 24 hours. The average daily adult dose of the resin is 15 g to 60 g. This is best provided by administering 15 g (approximately 4 level teaspoons) of sodium polystyrene sulfonate one to four times daily.

One gram of sodium polystyrene sulfonate contains 4.1 mEq of sodium; one level teaspoon contains approximately 3.5 g of sodium polystyrene sulfonate and 15 mEq of sodium (A heaping teaspoon may contain as much as 10 g to 12 g of sodium polystyrene sulfonate). Since the in vivo efficiency of sodium-potassium exchange resins is approximately 33 percent, about one third of the resin's actual sodium content is being delivered to the body. In smaller children and infants, lower doses should be employed by using as a guide a rate of 1 mEq of potassium per gram of resin as the basis for calculation Each dose should be given as a suspension in a small quantity of water or, for greater palatability, in syrup.

The amount of fluid usually ranges from 20 mL to 100 mL, depending on the dose, or may be simply determined by allowing 3 mL to 4 mL per gram of resin. Healthcare professionals should follow full aspiration precautions when administering this product, such as placing and maintaining the patient in an upright position while the resin is being administered. The resin may be introduced into the stomach through a plastic tube and, if desired, mixed with a diet appropriate for a patient in renal failure.

The resin may also be given, although with less effective results, in an enema consisting (for adults) of 30 g to 50 g every six hours. Each dose is administered as a warm emulsion (at body temperature) in 100 mL of aqueous vehicle. The emulsion should be agitated gently during administration.

The enema should be retained as long as possible and followed by a cleansing enema. After an initial cleansing enema, a soft, large size (French 28) rubber tube is inserted into the rectum for a distance of about 20 cm, with the tip well into the sigmoid colon, and taped in place. The resin is then suspended in the appropriate amount of aqueous vehicle at body temperature and introduced by gravity, while the particles are kept in suspension by stirring.

The suspension is flushed with 50 mL or 100 mL of fluid, following which the tube is clamped and left in place. If back leakage occurs, the hips are elevated on pillows or a knee-chest position is taken temporarily. A somewhat thicker suspension may be used, but care should be taken that no paste is formed, because the latter has a greatly reduced exchange surface and will be particularly ineffective if deposited in the rectal ampulla.

The suspension is kept in the sigmoid colon for several hours, if possible. Then, the colon is irrigated with nonsodium containing solution at body temperature in order to remove the resin. Two quarts of flushing solution may be necessary.

The returns are drained constantly through a Y tube connection. While the use of sorbitol is not recommended, particular attention should be paid to this cleansing enema if sorbitol has been used. The intensity and duration of therapy depend upon the severity and resistance of hyperkalemia.

Sodium polystyrene sulfonate should not be heated for to do so may alter the exchange properties of the resin.

⛔ Contraindications 43 words ▾

CONTRAINDICATIONS Sodium polystyrene sulfonate is contraindicated in the following conditions: patients with hypokalemia, patients with a history of hypersensitivity to polystyrene sulfonate resins, obstructive bowel disease, neonates with reduced gut motility (postoperatively or drug induced) and oral administration in neonates. (See PRECAUTIONS )

⚠️ Warnings ~2 min read ▾

WARNINGS Intestinal Necrosis Cases of intestinal necrosis, which may be fatal, and other serious gastrointestinal adverse events (bleeding, ischemic colitis, perforation) have been reported in association with sodium polystyrene sulfonate use. The majority of these cases reported the concomitant use of sorbitol. Risk factors for gastrointestinal adverse events were present in many of the cases including prematurity, history of intestinal disease or surgery, hypovolemia, and renal insufficiency and failure.

Concomitant administration of sorbitol is not recommended (see PRECAUTIONS, Drug Interactions ). Use only in patients who have normal bowel function. Avoid use in patients who have not had a bowel movement post-surgery.

Avoid use in patients who are at risk for developing constipation or impaction (including those with history of impaction, chronic constipation, inflammatory bowel disease, ischemic colitis, vascular intestinal atherosclerosis, previous bowel resection, or bowel obstruction). Discontinue use in patients who develop constipation. Alternative Therapy in Severe Hyperkalemia Since effective lowering of serum potassium with sodium polystyrene sulfonate may take hours to days, treatment with this drug alone may be insufficient to rapidly correct severe hyperkalemia associated with states of rapid tissue breakdown ( e.g., burns and renal failure) or hyperkalemia so marked as to constitute a medical emergency.

Therefore, other definitive measures, including dialysis, should always be considered and may be imperative. Hypokalemia Serious potassium deficiency can occur from therapy with sodium polystyrene sulfonate. The effect must be carefully controlled by frequent serum potassium determinations within each 24 hour period.

Since intracellular potassium deficiency is not always reflected by serum potassium levels, the level at which treatment with sodium polystyrene sulfonate should be discontinued must be determined individually for each patient. Important aids in making this determination are the patient's clinical condition and electrocardiogram. Early clinical signs of severe hypokalemia include a pattern of irritable confusion and delayed thought processes.

Electrocardiographically, severe hypokalemia is often associated with a lengthened Q-T interval, widening, flattening, or inversion of the T wave, and prominent U waves. Also, cardiac arrhythmias may occur, such as premature atrial, nodal, and ventricular contractions, and supraventricular and ventricular tachycardias. The toxic effects of digitalis are likely to be exaggerated.

Marked hypokalemia can also be manifested by severe muscle weakness, at times extending into frank paralysis. Electrolyte Disturbances Like all cation-exchange resins, sodium polystyrene sulfonate is not totally selective (for potassium) in its actions, and small amounts of other cations such as magnesium and calcium can also be lost during treatment. Accordingly, patients receiving sodium polystyrene sulfonate should be monitored for all applicable electrolyte disturbances.

Systemic Alkalosis Systemic alkalosis has been reported after cation-exchange resins were administered orally in combination with nonabsorbable cation-donating antacids and laxatives such as magnesium hydroxide and aluminum carbonate. Magnesium hydroxide should not be administered with sodium polystyrene sulfonate. One case of grand mal seizure has been reported in a patient with chronic hypocalcemia of renal failure who was given sodium polystyrene sulfonate with magnesium hydroxide as laxative (See PRECAUTIONS, Drug Interactions ).

🤒 Adverse Reactions 139 words ▾

ADVERSE REACTIONS Sodium polystyrene sulfonate may cause some degree of gastric irritation. Anorexia, nausea, vomiting, and constipation may occur especially if high doses are given. Also, hypokalemia, hypocalcemia, hypomagnesemia and significant sodium retention, and their related clinical manifestations, may occur (see WARNINGS ).

Occasionally diarrhea develops. Large doses in elderly individuals may cause fecal impaction (see PRECAUTIONS ). Rare instances of intestinal necrosis have been reported.

Intestinal obstruction due to concretions of aluminum hydroxide, when used in combination with sodium polystyrene sulfonate, has been reported. The following events have been reported from worldwide post marketing experience: Fecal impaction following rectal administration, particularly in children; Gastrointestinal concretions (bezoars) following oral administration; Ischemic colitis, gastrointestinal tract ulceration or necrosis which could lead to intestinal perforation; and, Rare cases of acute bronchitis and/or broncho-pneumonia associated with inhalation of particles of polystyrene sulfonate.

🔄 Drug Interactions 202 words ▾

Drug Interactions Antacids The simultaneous oral administration of sodium polystyrene sulfonate with nonabsorbable cation donating antacids and laxatives may reduce the resin's potassium exchange capability. Non-absorbable cation-donating antacids and laxatives Systemic alkalosis has been reported after cation-exchange resins were administered orally in combination with nonabsorbable cation-donating antacids and laxatives such as magnesium hydroxide and aluminum carbonate. Magnesium hydroxide should not be administered with sodium polystyrene sulfonate.

One case of grand mal seizure has been reported in a patient with chronic hypocalcemia of renal failure who was given sodium polystyrene sulfonate with magnesium hydroxide as a laxative. Intestinal obstruction due to concretions of aluminum hydroxide when used in combination with sodium polystyrene sulfonate has been reported. Digitalis The toxic effects of digitalis on the heart, especially various ventricular arrhythmias and A-V nodal dissociation, are likely to be exaggerated by hypokalemia, even in the face of serum digoxin concentrations in the "normal range" (See WARNINGS ).

Sorbitol Concomitant use of Sorbitol with sodium polystyrene sulfonate has been implicated in cases of intestinal necrosis, which may be fatal. Therefore, concomitant administration is not recommended (See WARNINGS ). Lithium Sodium polystyrene sulfonate may decrease absorption of lithium.

Thyroxine Sodium polystyrene sulfonate may decrease absorption of thyroxine.

🤰 Pregnancy 52 words ▾

Pregnancy Category C Animal reproduction studies have not been conducted with sodium polystyrene sulfonate. It is also not known whether sodium polystyrene sulfonate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sodium polystyrene sulfonate should be given to a pregnant woman only if clearly needed.

🧒 Pediatric Use 77 words ▾

Pediatric Use The effectiveness of sodium polystyrene sulfonate in pediatric patients has not been established. In neonates, sodium polystyrene sulfonate should not be given by the oral route. In both children and neonates particular care should be observed with rectal administration, as excessive dosage or inadequate dilution could result in impaction of the resin.

Due to the risk of digestive hemorrhage or intestinal necrosis, particular care should be observed in premature infants or low birth weight infants.

🆘 Overdosage 89 words ▾

OVERDOSAGE Overdosage may result in electrolyte disturbances including hypokalemia, hypocalcemia, and hypomagnesemia. Biochemical disturbances resulting from overdosage may give rise to clinical signs and symptoms of hypokalemia, including: irritability, confusion, delayed thought processes, muscle weakness, hyporeflexia, which may progress to frank paralysis and/or apnea. Tetany may occur.

Electrocardiographic changes may be consistent with hypokalemia or hypocalcemia; cardiac arrhythmias may occur. Appropriate measures should be taken to correct serum electrolytes (potassium, calcium, magnesium), and the resin should be removed from the alimentary tract by appropriate use of laxatives or enemas.

🧬 Clinical Pharmacology 93 words ▾

CLINICAL PHARMACOLOGY As the resin passes along the intestine or is retained in the colon after administration by enema, the sodium ions are partially released and are replaced by potassium ions. For the most part, this action occurs in the large intestine, which excretes potassium ions to a greater degree than does the small intestine. The efficiency of this process is limited and unpredictably variable.

It commonly approximates the order of 33 percent but the range is so large that definitive indices of electrolyte balance must be clearly monitored. Metabolic data are unavailable.

📦 How Supplied / Storage and Handling 71 words ▾

HOW SUPPLIED Sodium polystyrene sulfonate for suspension is available as a golden brown, finely ground powder in jars of 1 pound (454 g), NDC 10135-0146-17 and in bottles of 15 g, NDC 10135-0146-14. Store at 25° C (77° F); excursions permitted to 15° – 30° C (59° – 86° F) [see USP Controlled Room Temperature] Rx Only Manufactured for: Marlex Pharmaceuticals Inc. New Castle, DE 19720 Made in U.S.A Rev. 03/16SP

📋 Description 93 words ▾

DESCRIPTION Sodium polystyrene sulfonate is a benzene, diethenyl- polymer, with ethenylbenzene, sulfonated, sodium salt and has the following structural formula: The drug is a golden brown finely ground, powdered form of sodium polystyrene sulfonate, a cation exchange resin prepared in the sodium phase with an in vitro exchange capacity of approximately 3.1 mEq ( in vivo approximately 1 mEq) of potassium per gram. The sodium content is approximately 100 mg (4.1 mEq) per gram of the drug. It can be administered orally or in an enema.

The structural formula of Sodium polystyrene sulfonate.

⚠️ Precautions ~2 min read ▾

PRECAUTIONS Caution is advised when sodium polystyrene sulfonate is administered to patients who cannot tolerate even a small increase in sodium loads (i.e., severe congestive heart failure, severe hypertension, or marked edema). In such instances compensatory restriction of sodium intake from other sources may be indicated. In the event of clinically significant constipation, treatment with sodium polystyrene sulfonate should be discontinued until normal bowel motion is resumed (see WARNINGS, Intestinal Necrosis ).

Drug Interactions Antacids The simultaneous oral administration of sodium polystyrene sulfonate with nonabsorbable cation donating antacids and laxatives may reduce the resin's potassium exchange capability. Non-absorbable cation-donating antacids and laxatives Systemic alkalosis has been reported after cation-exchange resins were administered orally in combination with nonabsorbable cation-donating antacids and laxatives such as magnesium hydroxide and aluminum carbonate. Magnesium hydroxide should not be administered with sodium polystyrene sulfonate.

One case of grand mal seizure has been reported in a patient with chronic hypocalcemia of renal failure who was given sodium polystyrene sulfonate with magnesium hydroxide as a laxative. Intestinal obstruction due to concretions of aluminum hydroxide when used in combination with sodium polystyrene sulfonate has been reported. Digitalis The toxic effects of digitalis on the heart, especially various ventricular arrhythmias and A-V nodal dissociation, are likely to be exaggerated by hypokalemia, even in the face of serum digoxin concentrations in the "normal range" (See WARNINGS ).

Sorbitol Concomitant use of Sorbitol with sodium polystyrene sulfonate has been implicated in cases of intestinal necrosis, which may be fatal. Therefore, concomitant administration is not recommended (See WARNINGS ). Lithium Sodium polystyrene sulfonate may decrease absorption of lithium.

Thyroxine Sodium polystyrene sulfonate may decrease absorption of thyroxine. Carcinogenesis , Mutagenesis and Impairment of Fertility Studies have not been performed. Pregnancy Category C Animal reproduction studies have not been conducted with sodium polystyrene sulfonate.

It is also not known whether sodium polystyrene sulfonate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sodium polystyrene sulfonate should be given to a pregnant woman only if clearly needed. Nursing Mothers It is not known whether this drug is excreted in human milk.

Because many drugs are excreted in human milk, caution should be exercised when sodium polystyrene sulfonate is administered to a nursing woman. Pediatric Use The effectiveness of sodium polystyrene sulfonate in pediatric patients has not been established. In neonates, sodium polystyrene sulfonate should not be given by the oral route.

In both children and neonates particular care should be observed with rectal administration, as excessive dosage or inadequate dilution could result in impaction of the resin. Due to the risk of digestive hemorrhage or intestinal necrosis, particular care should be observed in premature infants or low birth weight infants.

🍼 Nursing Mothers 36 words ▾

Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when sodium polystyrene sulfonate is administered to a nursing woman.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 12 words ▾

Carcinogenesis , Mutagenesis and Impairment of Fertility Studies have not been performed.

📄 Package Label / Principal Display Panel 17 words ▾

PRINCIPAL DISPLAY PANEL NDC 10135-0146-17 Marlex Sodium Polystyrene Sulfonate for Suspension 454 g (1 lb) sod polystyrene

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 Sodium Polystyrene Sulfonate — the program that covers self-administered drugs. 6 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 Sodium Polystyrene Sulfonate. 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
$858.1K
Claims incl. refills
13.3K
Beneficiaries
10.4K
Spend / beneficiary
$82.68
Spend / claim
$64.41
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.

About this NDC listing & data coverage

Finished prescription product No longer marketed (per FDA listing data)
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 — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
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.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
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.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 15 g (10135-0146-14). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Marlex Pharmaceuticals Inc 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.
← 10129-0715-03 · Gingi-Pak 10135-0314-01 · Marlex →
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.