Potassium-cit
NDC Package 71930-049-12

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Potassium-cit is rate extended-release tablets is contraindicated:In patients with hyperkalemia (or who have conditions pre-disposing them to hyperkalemia), as a further rise in serum potassium concentration may produce cardiac arrest. Marketed by Eywa Pharma Inc, this product is identified by NDC 71930-049 and is authorized under FDA application ANDA214426.

Identification & Billing

NDC Package Code
71930-049-12
Package Description
100 TABLET, EXTENDED RELEASE in 1 BOTTLE
Product Code
71930-049
11-Digit Billing Format
71930004912
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-cit
Dosage Form
-
Usage Information
Potassium citrate extended-release tablets is contraindicated:In patients with hyperkalemia (or who have conditions pre-disposing them to hyperkalemia), as a further rise in serum potassium concentration may produce cardiac arrest. Such conditions include: chronic renal failure, uncontrolled diabetes mellitus, acute dehydration, strenuous physical exercise in unconditioned individuals, adrenal insufficiency, extensive tissue breakdown or the administration of a potassium-sparing agent (such as triamterene, spironolactone or amiloride).In patients in whom there is cause for arrest or delay in tablet passage through the gastrointestinal tract, such as those suffering from delayed gastric emptying, esophageal compression, intestinal obstruction or stricture, or those taking anticholinergic medication.In patients with peptic ulcer disease because of its ulcerogenic potential.In patients with active urinary tract infection (with either urea-splitting or other organisms, in association with either calcium or struvite stones). The ability of potassium citrate extended-release tablet to increase urinary citrate may be attenuated by bacterial enzymatic degradation of citrate. Moreover, the rise in urinary pH resulting from potassium citrate extended-release tablet therapy might promote further bacterial growth.In patients with renal insufficiency (glomerular filtration rate of less than 0.7 ml/kg/min), because of the danger of soft tissue calcification and increased risk for the development of hyperkalemia.

Regulatory & Marketing

Labeler Name
Eywa Pharma Inc
FDA Application #
ANDA214426
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-01-2021
Listing Expiration
12-31-2023
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 71930-049-12 identifies a specific commercial package of 100 tablet, extended release in 1 bottle of Potassium-cit, labeled by Eywa Pharma Inc. 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 Eywa Pharma Inc on March 01, 2021. The current certification is valid through December 31, 2023.

How is this Eywa Pharma Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 71930004912. 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)
71930-049-12
11-Digit CMS (5-4-2)
71930-0049-12

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