Potassium Citrate Tablet
NDC Package 42543-407-01

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Potassium Citrate tablets is a medication used to make the urine less acidic. This formulation utilizes a tablet delivery system. Marketed by Strides Pharma Inc., this product is identified by NDC 42543-407 and is authorized under FDA application ANDA206813.

Identification & Billing

NDC Package Code
42543-407-01
Package Description
100 TABLET in 1 BOTTLE
Product Code
42543-407
11-Digit Billing Format
42543040701
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
100 EA
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 Extended Release
Non-Proprietary Name
Potassium Citrate
Substance Name
Potassium Citrate
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 CITRATE 10 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
Strides Pharma Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA206813
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-01-2017
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 42543-407-01 identifies a specific commercial package of 100 tablet in 1 bottle of Potassium Citrate Extended Release, a human prescription drug labeled by Strides Pharma Inc.. This tablet 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 Strides Pharma Inc. on November 01, 2017. The current certification is valid through December 31, 2027.

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 Strides Pharma Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 42543040701. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 100 total billable units per package. 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)
42543-407-01
11-Digit CMS (5-4-2)
42543-0407-01

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