Potassium Citrate Tablet, Extended Release
NDC Package 65841-536-01

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

Potassium Citrate tablets is a medication used to make the urine less acidic. This formulation utilizes a tablet, extended release delivery system. Marketed by Zydus Lifesciences Limited, this product is identified by NDC 65841-536 and is authorized under FDA application ANDA203546.

Identification & Billing

NDC Package Code
65841-536-01
Package Description
100 TABLET, EXTENDED RELEASE in 1 BOTTLE
Product Code
65841-536
11-Digit Billing Format
65841053601
RxNorm Crosswalk
  • RxCUI: 199376 - potassium citrate 5 MEQ Extended Release Oral Tablet
  • RxCUI: 199376 - K+ citrate 5 MEQ Extended Release Oral Tablet
  • RxCUI: 199376 - Pot citrate 5 MEQ Extended Release Oral Tablet
  • RxCUI: 199376 - potassium citrate 540 MG Extended Release Oral Tablet
  • RxCUI: 199381 - potassium citrate 10 MEQ Extended Release Oral Tablet

Clinical Specifications

Proprietary Name
Potassium Citrate
Non-Proprietary Name
Potassium Citrate
Substance Name
Potassium Citrate
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 CITRATE 5 meq/1
Pharmacologic Class
Usage Information
This medication is used to make the urine less acidic. This effect helps the kidneys get rid of uric acid, thereby helping to prevent gout and kidney stones. This medication can also prevent and treat certain metabolic problems (acidosis) caused by kidney disease. Citric acid and citrate salts (which contain potassium and sodium) belong to a class of drugs known as urinary alkalinizers. If you have a condition that requires you to limit your intake of potassium and sodium, your doctor may direct you to take a product that is lower in potassium and sodium.

Regulatory & Marketing

Labeler Name
Zydus Lifesciences Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA203546
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
08-12-2014
Listing Expiration
12-31-2026
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 (65841-536). Click a package code to view its specific billing and regulatory data.

65841-536-05
500 TABLET, EXTENDED RELEASE in 1 BOTTLE
65841-536-06
30 TABLET, EXTENDED RELEASE in 1 BOTTLE
65841-536-10
1000 TABLET, EXTENDED RELEASE in 1 BOTTLE
65841-536-16
90 TABLET, EXTENDED RELEASE in 1 BOTTLE
65841-536-30
10 BLISTER PACK in 1 CARTON / 10 TABLET, 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 65841-536-01 identifies a specific commercial package of 100 tablet, extended release in 1 bottle of Potassium Citrate, a human prescription drug labeled by Zydus Lifesciences Limited. This tablet, extended release is formulated for oral use and contains potassium citrate 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 Zydus Lifesciences Limited on August 12, 2014. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used to make the urine less acidic. This effect helps the kidneys get rid of uric acid, thereby helping to prevent gout and kidney stones. This medication can also prevent and treat certain metabolic problems (acidosis) caused by kidney disease. Citric acid and citrate salts (which contain potassium and sodium) belong to a class of drugs known as urinary alkalinizers. If you have a condition that requires you to limit your intake of potassium and sodium, your doctor may direct you to take a product that is lower in potassium and sodium.

How is this Zydus Lifesciences Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 65841053601. 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)
65841-536-01
11-Digit CMS (5-4-2)
65841-0536-01

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