Renacidin Solution
NDC Package 0327-0012-30

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

Package Information

Renacidin (citric acid, gluconolactone and magnesium carbonate) solution is renacidin is indicated for dissolution of bladder calculi of the struvite or apatite variety by local intermittent irrigation through a urethral catheter or cystostomy tube as an alternative or adjunct to surgical procedures. This formulation utilizes a solution delivery system. Marketed by United-guardian, Inc., this product is identified by NDC 0327-0012 and is authorized under FDA application NDA019481.

Identification & Billing

NDC Package Code
0327-0012-30
Package Description
30 BOTTLE in 1 CARTON / 30 mL in 1 BOTTLE
Product Code
0327-0012
11-Digit Billing Format
00327001230
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk
  • RxCUI: 1792396 - citric acid 1980.6 MG / gluconolactone 59.4 MG / magnesium carbonate 980.4 MG in 30 ML Irrigation Solution
  • RxCUI: 1792396 - citric acid 66 MG/ML / gluconolactone 1.98 MG/ML / magnesium carbonate 32.7 MG/ML Irrigation Solution
  • RxCUI: 1792396 - citric acid 1980.6 MG / gluconolactone 59.4 MG / magnesium carbonate 980.4 MG per 30 ML Irrigation Solution
  • RxCUI: 1792396 - citric acid 6.602 GM / gluconolactone 0.198 GM / magnesium carbonate 3.268 GM per 100 ML Irrigation Solution
  • RxCUI: 1792398 - RENACIDIN 1980.6 MG / 59.4 MG / 980.4 MG in 30 ML Irrigation Solution

Clinical Specifications

Proprietary Name
Renacidin
Non-Proprietary Name
Citric Acid, Gluconolactone And Magnesium Carbonate
Substance Name
Anhydrous Citric Acid; Gluconolactone; Magnesium Carbonate
Dosage Form
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Administration Route
Irrigation - Administration to bathe or flush open wounds or body cavities.
Active Ingredient(s)
Pharmacologic Class
Usage Information
Renacidin is indicated for dissolution of bladder calculi of the struvite or apatite variety by local intermittent irrigation through a urethral catheter or cystostomy tube as an alternative or adjunct to surgical procedures. Renacidin is also indicated for use as an intermittent irrigating solution to prevent encrustations of indwelling urethral catheters and cystostomy tubes.

Regulatory & Marketing

Labeler Name
United-guardian, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA019481
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
02-01-2016
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 0327-0012-30 identifies a specific commercial package of 30 bottle in 1 carton / 30 ml in 1 bottle of Renacidin, a human prescription drug labeled by United-guardian, Inc.. This solution is formulated for irrigation use and contains anhydrous citric acid; gluconolactone; magnesium carbonate 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 United-guardian, Inc. on February 01, 2016. The current certification is valid through December 31, 2026.

How is this United-guardian, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00327001230. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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 (4-4-2)
0327-0012-30
11-Digit CMS (5-4-2)
00327-0012-30

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