Sodium Zirconium Cyclosilicate Powder
NDC Package 65977-0132-1

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

Package Information

This product is an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Sodium Zirconium Cyclosilicate powders is a medication used to treat high levels of potassium in the blood. This formulation utilizes a powder delivery system. Marketed by Hetero Drugs Limited, this product is identified by NDC 65977-0132.

Identification & Billing

NDC Package Code
65977-0132-1
Package Description
40 kg in 1 DRUM
Product Code
65977-0132
11-Digit Billing Format
65977013201

Clinical Specifications

Proprietary Name
Sodium Zirconium Cyclosilicate
Non-Proprietary Name
Sodium Zirconium Cyclosilicate
Substance Name
Sodium Zirconium Cyclosilicate
Dosage Form
Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.
Active Ingredient(s)
SODIUM ZIRCONIUM CYCLOSILICATE 1 kg/kg
Usage Information
This medication is used to treat high levels of potassium in the blood. It works by binding to potassium in the gut. This medication does not work right away, and should not be used to treat life-threatening high levels of potassium. High potassium levels can cause symptoms such as nausea, muscle weakness/tiredness, irregular heartbeats, or paralysis.

Regulatory & Marketing

Labeler Name
Hetero Drugs Limited
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
05-18-2018
Listing Expiration
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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 65977-0132-1 identifies a specific commercial package of 40 kg in 1 drum of Sodium Zirconium Cyclosilicate (UNFINISHED drug), a bulk ingredient labeled by Hetero Drugs Limited. This powder is formulated for use and contains sodium zirconium cyclosilicate 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 Hetero Drugs Limited on May 18, 2018. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used to treat high levels of potassium in the blood. It works by binding to potassium in the gut. This medication does not work right away, and should not be used to treat life-threatening high levels of potassium. High potassium levels can cause symptoms such as nausea, muscle weakness/tiredness, irregular heartbeats, or paralysis.

How is this Hetero Drugs Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 65977013201. 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 (5-4-1)
65977-0132-1
11-Digit CMS (5-4-2)
65977-0132-01

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