Methenamine Mandelate Solution
NDC Package 85477-115-16

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

Package Information

Methenamine Mandelate solution is methenamine is used to prevent or control returning urinary tract infections caused by certain bacteria. This formulation utilizes a solution delivery system. Marketed by Oncora Pharma, Llc, this product is identified by NDC 85477-115.

Identification & Billing

NDC Package Code
85477-115-16
Package Description
473 mL in 1 BOTTLE
Product Code
85477-115
11-Digit Billing Format
85477011516
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Methenamine Mandelate
Non-Proprietary Name
Methenamine Mandelate
Substance Name
Methenamine Mandelate
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
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
METHENAMINE MANDELATE 500 mg/5mL
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
Oncora Pharma, Llc
Product Type
Human Prescription Drug
Marketing Category
UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.
Start Marketing Date
04-20-2026
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 85477-115-16 identifies a specific commercial package of 473 ml in 1 bottle of Methenamine Mandelate, a human prescription drug labeled by Oncora Pharma, Llc. This solution is formulated for oral use and contains methenamine mandelate 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 Oncora Pharma, Llc on April 20, 2026. The current certification is valid through December 31, 2027.

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 Oncora Pharma, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 85477011516. 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)
85477-115-16
11-Digit CMS (5-4-2)
85477-0115-16

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