Potassium Chloride Tablet, Film Coated, Extended Release
NDC Package 33342-417-12

11-digit billing NDC: 33342041712
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Potassium Chloride tablets is potassium chloride extended-release tablets are indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction is insufficient. This formulation utilizes a tablet, film coated, extended release delivery system. Marketed by Macleods Pharmaceuticals Limited, this product is identified by NDC 33342-417 and is authorized under FDA application ANDA212987.

Identification & Billing

NDC Package Code
33342-417-12
Package Description
10 BLISTER PACK in 1 CARTON / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
Product Code
33342-417
11-Digit Billing Format
33342041712
RxNorm Crosswalk
  • RxCUI: 312529 - potassium chloride 8 MEQ (600 MG) Extended Release Oral Tablet
  • RxCUI: 312529 - potassium chloride 8 MEQ Extended Release Oral Tablet
  • RxCUI: 312529 - K+ Chloride 8 MEQ Extended Release Oral Tablet
  • RxCUI: 312529 - Pot Chloride 8 MEQ Extended Release Oral Tablet
  • RxCUI: 312529 - potassium chloride 600 MG Extended Release Oral Tablet

Clinical Specifications

Proprietary Name
Potassium Chloride
Non-Proprietary Name
Potassium Chloride
Substance Name
Potassium Chloride
Dosage Form
Tablet, Film Coated, Extended Release - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer; the tablet is formulated in such manner as to make the contained medicament available over an extended period of time following ingestion.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
POTASSIUM CHLORIDE 600 mg/1
Pharmacologic Class
Usage Information
Potassium chloride extended-release tablets are indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction is insufficient.

Regulatory & Marketing

Labeler Name
Macleods Pharmaceuticals Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA212987
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-08-2024
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 (33342-417). Click a package code to view its specific billing and regulatory data.

33342-417-11
100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE
33342-417-15
500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE
33342-417-34
10 BLISTER PACK in 1 CARTON / 7 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK

* 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 33342-417-12 identifies a specific commercial package of 10 blister pack in 1 carton / 10 tablet, film coated, extended release in 1 blister pack of Potassium Chloride, a human prescription drug labeled by Macleods Pharmaceuticals Limited. This tablet, film coated, 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 Macleods Pharmaceuticals Limited on September 08, 2024. The current certification is valid through December 31, 2027.

How is this Macleods Pharmaceuticals Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 33342041712. 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)
33342-417-12
11-Digit CMS (5-4-2)
33342-0417-12

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