Methenamine Mandelate
NDC Package 54868-3040-1

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 discontinued by the firm.

Methenamine Mandelate is methenamine is used to prevent or control returning urinary tract infections caused by certain bacteria. Marketed by Physicians Total Care, Inc., this product is identified by NDC 54868-3040.

Identification & Billing

NDC Package Code
54868-3040-1
Package Description
1 BLISTER PACK in 1 BOTTLE / 30 TABLET, FILM COATED in 1 BLISTER PACK
Product Code
54868-3040
11-Digit Billing Format
54868304001

Clinical Specifications

Proprietary Name
Methenamine Mandelate
Dosage Form
-
Usage Information
Methenamine is used to prevent or control returning urinary tract infections caused by certain bacteria. It is not used to treat an active infection. Other antibiotics must be used first to treat and cure the infection. Methenamine is an antibiotic that stops the growth of bacteria in urine. This medication also contains an ingredient that helps to make the urine acidic. When the urine is acidic, methenamine turns into formaldehyde to kill the bacteria. This antibiotic is effective only against bacterial infections in the urinary tract. It will not work for other types of bacterial infections (such as in the blood) or for viral infections (such as the common cold or flu). Unnecessary use or misuse of any antibiotic can lead to its decreased effectiveness.

Regulatory & Marketing

Labeler Name
Physicians Total Care, Inc.
Marketing Category
UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.
Start Marketing Date
02-01-2010
End Marketing Date
06-30-2013
Listing Expiration
06-30-2013
Exclude Flag
D
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 54868-3040-1 identifies a specific commercial package of 1 blister pack in 1 bottle / 30 tablet, film coated in 1 blister pack of Methenamine Mandelate, labeled by Physicians Total Care, 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 Physicians Total Care, Inc. on February 01, 2010. The current certification is valid through June 30, 2013.

What are the primary indications for this medication?

Methenamine is used to prevent or control returning urinary tract infections caused by certain bacteria. It is not used to treat an active infection. Other antibiotics must be used first to treat and cure the infection. Methenamine is an antibiotic that stops the growth of bacteria in urine. This medication also contains an ingredient that helps to make the urine acidic. When the urine is acidic, methenamine turns into formaldehyde to kill the bacteria. This antibiotic is effective only against bacterial infections in the urinary tract. It will not work for other types of bacterial infections (such as in the blood) or for viral infections (such as the common cold or flu). Unnecessary use or misuse of any antibiotic can lead to its decreased effectiveness.

How is this Physicians Total Care, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 54868304001. 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)
54868-3040-1
11-Digit CMS (5-4-2)
54868-3040-01

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