Potassium Chloride Extended-release
NDC Package 67046-1340-3

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 EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Potassium Chloride Extended-release is bECAUSE OF REPORTS OF INTESTINAL AND GASTRIC ULCERATION AND BLEEDING WITH CONTROLLED-RELEASE POTASSIUM CHLORIDE PREPARATIONS, THESE DRUGS SHOULD BE RESERVED FOR THOSE PATIENTS WHO CANNOT TOLERATE OR REFUSE TO TAKE LIQUID OR EFFERVESCENT POTASSIUM PREPARATIONS OR FOR PATIENTS IN WHOM THERE IS A PROBLEM OF COMPLIANCE WITH THESE PREPARATIONS. Marketed by Coupler Llc, this product is identified by NDC 67046-1340 and is authorized under FDA application ANDA214452.

Identification & Billing

NDC Package Code
67046-1340-3
Package Description
30 TABLET in 1 BLISTER PACK
Product Code
67046-1340
11-Digit Billing Format
67046134003
RxNorm Crosswalk
  • RxCUI: 1801294 - potassium chloride 20 MEQ Microencapsulated Extended Release Oral Tablet
  • RxCUI: 1801294 - Microencapsulated potassium chloride 20 MEQ Extended Release Oral Tablet
  • RxCUI: 1801294 - Microencapsulated K+ Chloride 20 MEQ Extended Release Oral Tablet
  • RxCUI: 1801294 - Microencapsulated Pot Chloride 20 MEQ Extended Release Oral Tablet
  • RxCUI: 1801294 - potassium chloride 1500 MG Microencapsulated Extended Release Oral Tablet

Clinical Specifications

Proprietary Name
Potassium Chloride Extended-release
Dosage Form
-
Usage Information
BECAUSE OF REPORTS OF INTESTINAL AND GASTRIC ULCERATION AND BLEEDING WITH CONTROLLED-RELEASE POTASSIUM CHLORIDE PREPARATIONS, THESE DRUGS SHOULD BE RESERVED FOR THOSE PATIENTS WHO CANNOT TOLERATE OR REFUSE TO TAKE LIQUID OR EFFERVESCENT POTASSIUM PREPARATIONS OR FOR PATIENTS IN WHOM THERE IS A PROBLEM OF COMPLIANCE WITH THESE PREPARATIONS.     1. For the treatment of patients with hypokalemia with or without metabolic alkalosis, in digitalis intoxication and in patients with hypokalemic familial periodic paralysis. If hypokalemia is the         result of  diuretic therapy, consideration should be given to the use of a lower dose of diuretic, which may be sufficient without leading to hypokalemia.     2. For the prevention of hypokalemia in patients who would be at particular risk if hypokalemia were to develop, e.g., digitalized patients or patients with significant cardiac arrhythmias. The use of potassium salts in patients receiving diuretics for uncomplicated essential hypertension is often unnecessary when such patients have a normal dietary pattern and when low doses of the diuretic are used. Serum potassium should be checked periodically, however, and if hypokalemia occurs, dietary supplementation with potassium-containing foods may be adequate to control milder cases. In more severe cases, and if dose adjustment of the diuretic is ineffective or unwarranted, supplementation with potassium salts may be indicated.

Regulatory & Marketing

Labeler Name
Coupler Llc
FDA Application #
ANDA214452
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-11-2024
Listing Expiration
12-31-2025
Exclude Flag
I
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 67046-1340-3 identifies a specific commercial package of 30 tablet in 1 blister pack of Potassium Chloride Extended-release, labeled by Coupler Llc. 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 Coupler Llc on November 11, 2024. The current certification is valid through December 31, 2025.

How is this Coupler Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 67046134003. 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)
67046-1340-3
11-Digit CMS (5-4-2)
67046-1340-03

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