Sodium Polystyrene Sulfonate
NDC Package 0054-0165-63

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

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Sodium Polystyrene Sulfonate is a medication used to treat a high level of potassium in your blood. Marketed by Roxane Laboratories Inc, this product is identified by NDC 0054-0165 and is authorized under FDA application ANDA089049.

Identification & Billing

NDC Package Code
0054-0165-63
Package Description
500 mL in 1 BOTTLE
Product Code
0054-0165
11-Digit Billing Format
00054016563

Clinical Specifications

Proprietary Name
Sodium Polystyrene Sulfonate
Dosage Form
-
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
Roxane Laboratories Inc
FDA Application #
ANDA089049
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
08-03-2005
End Marketing Date
11-10-2008
Listing Expiration
11-10-2008
Exclude Flag
D
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 (0054-0165). Click a package code to view its specific billing and regulatory data.

0054-0165-50
120 mL in 1 BOTTLE
0054-0165-51
10 BOTTLE in 1 CARTON / 60 mL in 1 BOTTLE
0054-0165-55
200 mL in 1 BOTTLE

* 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 0054-0165-63 identifies a specific commercial package of 500 ml in 1 bottle of Sodium Polystyrene Sulfonate, labeled by Roxane Laboratories Inc. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Roxane Laboratories Inc on August 03, 2005. The current certification is valid through November 10, 2008.

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 Roxane Laboratories Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00054016563. 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 (4-4-2)
0054-0165-63
11-Digit CMS (5-4-2)
00054-0165-63

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