Sodium Polystyrene Sulfonate Powder, For Suspension
NDC Package 11534-166-16

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

Package Information

Sodium Polystyrene Sulfonate powders is a medication used to treat a high level of potassium in your blood. This formulation utilizes a powder, for suspension delivery system. Marketed by Sunrise Pharmaceutical, Inc., this product is identified by NDC 11534-166 and is authorized under FDA application ANDA204071.

Identification & Billing

NDC Package Code
11534-166-16
Package Description
15 g in 1 BOTTLE
Product Code
11534-166
11-Digit Billing Format
11534016616
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
Units Per Package
15 GM
RxNorm Crosswalk
  • RxCUI: 2101899 - sodium polystyrene sulfonate 15 GM Powder for Suspension
  • RxCUI: 2101899 - sodium polystyrene sulfonate 15000 MG Powder for Oral Suspension
  • RxCUI: 2101899 - sodium polystyrene sulfonate 15 to 60 GM Powder for Oral Suspension
  • RxCUI: 2101899 - sodium polystyrene sulfonate 30 to 50 GM Powder for Rectal Suspension
  • RxCUI: 2101899 - sodium polystyrene sulfonate 4.1 MEQ in 1 GM Powder for Oral Suspension

Clinical Specifications

Proprietary Name
Sodium Polystyrene Sulfonate
Non-Proprietary Name
Sodium Polystyrene Sulfonate
Substance Name
Sodium Polystyrene Sulfonate
Dosage Form
Powder, For Suspension - An intimate mixture of dry, finely divided drugs and/or chemicals, which, upon the addition of suitable vehicles, yields a suspension (a liquid preparation containing the solid particles dispersed in the liquid vehicle).
Administration Route
  • Oral - Administration to or by way of the mouth.
  • Rectal - Administration to the rectum.
Active Ingredient(s)
SODIUM POLYSTYRENE SULFONATE 4.1 meq/g
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
Sunrise Pharmaceutical, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA204071
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-24-2017
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (11534-166). Click a package code to view its specific billing and regulatory data.

11534-166-15
15 g in 1 BOTTLE
11534-166-44
454 g in 1 JAR

* 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 11534-166-16 identifies a specific commercial package of 15 g in 1 bottle of Sodium Polystyrene Sulfonate, a human prescription drug labeled by Sunrise Pharmaceutical, Inc.. This powder, for 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 Sunrise Pharmaceutical, Inc. on January 24, 2017. 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 Sunrise Pharmaceutical, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 11534016616. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. There are 15 total billable units per package. 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)
11534-166-16
11-Digit CMS (5-4-2)
11534-0166-16

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