Potassium Citrate
NDC Package 63629-7980-1

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 Citrate 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 Bryant Ranch Prepack, this product is identified by NDC 63629-7980 and is authorized under FDA application ANDA209758.

Identification & Billing

NDC Package Code
63629-7980-1
Package Description
30 TABLET, EXTENDED RELEASE in 1 BOTTLE
Product Code
63629-7980
11-Digit Billing Format
63629798001
RxNorm Crosswalk
  • RxCUI: 199381 - potassium citrate 10 MEQ Extended Release Oral Tablet
  • RxCUI: 199381 - K+ citrate 10 MEQ Extended Release Oral Tablet
  • RxCUI: 199381 - Pot citrate 10 MEQ Extended Release Oral Tablet
  • RxCUI: 199381 - potassium citrate 1080 MG Extended Release Oral Tablet

Clinical Specifications

Proprietary Name
Potassium Citrate
Dosage Form
-
Usage Information
Potassium citrate 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 to increase urinary citrate may be attenuated by bacterial enzymatic degradation of citrate. Moreover, the rise in urinary pH resulting from potassium citrate 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
Bryant Ranch Prepack
FDA Application #
ANDA209758
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
05-30-2018
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 63629-7980-1 identifies a specific commercial package of 30 tablet, extended release in 1 bottle of Potassium Citrate, labeled by Bryant Ranch Prepack. 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 Bryant Ranch Prepack on May 30, 2018. The current certification is valid through December 31, 2023.

How is this Bryant Ranch Prepack product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 63629798001. 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 (5-4-1)
63629-7980-1
11-Digit CMS (5-4-2)
63629-7980-01

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