Sodium Polystyrene Sulfonate Suspension
NDC Package 35573-108-14

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Sodium Polystyrene Sulfonate suspension is a medication used to treat a high level of potassium in your blood. This formulation utilizes a suspension delivery system. Marketed by Burel Pharmaceuticals, Llc, this product is identified by NDC 35573-108 and is authorized under FDA application ANDA214912.

Identification & Billing

NDC Package Code
35573-108-14
Package Description
10 BOTTLE, UNIT-DOSE in 1 CARTON / 60 mL in 1 BOTTLE, UNIT-DOSE (35573-108-13)
Product Code
35573-108
11-Digit Billing Format
35573010814
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk
  • RxCUI: 313072 - sodium polystyrene sulfonate 15 GM in 60 mL Oral or Rectal Suspension
  • RxCUI: 313072 - sodium polystyrene sulfonate 250 MG/ML Oral Suspension
  • RxCUI: 313072 - sodium polystyrene sulfonate 15 GM per 60 ML Oral Suspension
  • RxCUI: 313072 - sodium polystyrene sulfonate 30 GM per 120 ML Oral Suspension

Clinical Specifications

Proprietary Name
Sodium Polystyrene Sulfonate
Non-Proprietary Name
Sodium Polystyrene Sulfonate
Substance Name
Sodium Polystyrene Sulfonate
Dosage Form
Suspension - A liquid1 dosage form that contains solid particles dispersed in a liquid vehicle.
Administration Route
  • Oral - Administration to or by way of the mouth.
  • Rectal - Administration to the rectum.
Active Ingredient(s)
SODIUM POLYSTYRENE SULFONATE 15 g/60mL
Usage Information
This medication is used to treat a high level of potassium in your blood. Too much potassium in your blood can sometimes cause heart rhythm problems. Sodium polystyrene sulfonate works by helping your body get rid of extra potassium.

Regulatory & Marketing

Labeler Name
Burel Pharmaceuticals, Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA214912
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-18-2025
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 35573-108-14 identifies a specific commercial package of 10 bottle, unit-dose in 1 carton / 60 ml in 1 bottle, unit-dose (35573-108-13) of Sodium Polystyrene Sulfonate, a human prescription drug labeled by Burel Pharmaceuticals, Llc. This suspension is formulated for oral; rectal use and contains sodium polystyrene sulfonate as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Burel Pharmaceuticals, Llc on December 18, 2025. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used to treat a high level of potassium in your blood. Too much potassium in your blood can sometimes cause heart rhythm problems. Sodium polystyrene sulfonate works by helping your body get rid of extra potassium.

How is this Burel Pharmaceuticals, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 35573010814. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
35573-108-14
11-Digit CMS (5-4-2)
35573-0108-14

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.