K-tab
NDC Package 43353-790-85

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 inactivated by the FDA.

K-tab 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 WITH WHOM THERE IS A PROBLEM OF COMPLIANCE WITH THESE PREPARATIONS. Marketed by Aphena Pharma Solutions - Tennessee, Llc, this product is identified by NDC 43353-790 and is authorized under FDA application NDA018279.

Identification & Billing

NDC Package Code
43353-790-85
Package Description
200 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC
Product Code
43353-790
11-Digit Billing Format
43353079085
RxNorm Crosswalk
  • RxCUI: 628953 - potassium chloride 10 MEQ (750 MG) Extended Release Oral Tablet
  • RxCUI: 628953 - potassium chloride 10 MEQ Extended Release Oral Tablet
  • RxCUI: 628953 - K+ Chloride 10 MEQ Extended Release Oral Tablet
  • RxCUI: 628953 - Pot Chloride 10 MEQ Extended Release Oral Tablet
  • RxCUI: 628953 - potassium chloride 750 MG (potassium 10 mEq) Extended Release Oral Tablet

Clinical Specifications

Proprietary Name
K-tab
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 WITH 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
Aphena Pharma Solutions - Tennessee, Llc
FDA Application #
NDA018279
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
06-09-1980
Listing Expiration
12-31-2019
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (43353-790). Click a package code to view its specific billing and regulatory data.

43353-790-30
30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC
43353-790-53
60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC
43353-790-60
90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC
43353-790-70
120 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC
43353-790-80
180 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC
43353-790-92
270 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC
43353-790-94
360 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC

* 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 43353-790-85 identifies a specific commercial package of 200 tablet, film coated, extended release in 1 bottle, plastic of K-tab, labeled by Aphena Pharma Solutions - Tennessee, 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 Aphena Pharma Solutions - Tennessee, Llc on June 09, 1980. The current certification is valid through December 31, 2019.

How is this Aphena Pharma Solutions - Tennessee, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 43353079085. 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)
43353-790-85
11-Digit CMS (5-4-2)
43353-0790-85

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