Potassium Chloride Tablet
NDC Package 43547-549-10

11-digit billing NDC: 43547054910
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Potassium Chloride (potassium chloride extended-release) 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. This formulation utilizes a tablet delivery system. Marketed by Solco Healthcare Llc, this product is identified by NDC 43547-549 and is authorized under FDA application ANDA209922.

Identification & Billing

NDC Package Code
43547-549-10
Package Description
100 TABLET in 1 BOTTLE
Product Code
43547-549
11-Digit Billing Format
43547054910
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
Non-Proprietary Name
Potassium Chloride Extended-release
Substance Name
Potassium Chloride
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
POTASSIUM CHLORIDE 750 mg/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. 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, eg, 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
Solco Healthcare Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA209922
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
04-30-2019
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 (43547-549). Click a package code to view its specific billing and regulatory data.

43547-549-50
500 TABLET 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 43547-549-10 identifies a specific commercial package of 100 tablet in 1 bottle of Potassium Chloride, a human prescription drug labeled by Solco Healthcare Llc. This tablet 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 Solco Healthcare Llc on April 30, 2019. The current certification is valid through December 31, 2027.

How is this Solco Healthcare Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 43547054910. 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)
43547-549-10
11-Digit CMS (5-4-2)
43547-0549-10

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