Potassium Chloride Tablet, Extended Release
NDC Package 50090-8163-2

11-digit billing NDC: 50090816302
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Potassium Chloride tablets 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.For the treatment of patients with hypokalemia with or without metabolic alkalosis, in digitalis intoxication, and in patients with hypokalemic familial periodic paralysis. This formulation utilizes a tablet, extended release delivery system. Marketed by A-s Medication Solutions, this product is identified by NDC 50090-8163 and is authorized under FDA application ANDA076368.

Identification & Billing

NDC Package Code
50090-8163-2
Package Description
90 TABLET, EXTENDED RELEASE in 1 BOTTLE
Product Code
50090-8163
11-Digit Billing Format
50090816302

Clinical Specifications

Proprietary Name
Potassium Chloride
Non-Proprietary Name
Potassium Chloride
Substance Name
Potassium Chloride
Dosage Form
Tablet, Extended Release - A solid dosage form containing a drug which allows at least a reduction in dosing frequency as compared to that drug presented in conventional dosage form.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
POTASSIUM CHLORIDE 20 meq/1
Pharmacologic Class
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.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.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
A-s Medication Solutions
Product Type
Human Prescription Drug
FDA Application #
ANDA076368
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-14-2023
Listing Expiration
12-31-2027
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 (50090-8163). Click a package code to view its specific billing and regulatory data.

50090-8163-0
30 TABLET, EXTENDED RELEASE in 1 BOTTLE
50090-8163-1
60 TABLET, EXTENDED RELEASE 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 50090-8163-2 identifies a specific commercial package of 90 tablet, extended release in 1 bottle of Potassium Chloride, a human prescription drug labeled by A-s Medication Solutions. This tablet, extended release is formulated for oral use and contains potassium chloride 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 A-s Medication Solutions on November 14, 2023. The current certification is valid through December 31, 2027.

How is this A-s Medication Solutions product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 50090816302. 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)
50090-8163-2
11-Digit CMS (5-4-2)
50090-8163-02

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