Methenamine Mandelate Solution
NDC Package 85477-115-16

11-digit billing NDC: 85477011516 · Billing unit: ML · 473 ML per package
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Methenamine Mandelate solution is methenamine mandelate, USP is indicated for the suppression or elimination of bacteriuria associated with pyelonephritis, cystitis, and other chronic urinary tract infections; also for infected residual urine sometimes accompanying neurologic diseases. When used as recommended, methenamine mandelate, USP is particularly suitable for long-term therapy because of its safety and because resistance to the nonspecific bactericidal action of formaldehyde does not develop. 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
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
473 ML
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 mandelate, USP is indicated for the suppression or elimination of bacteriuria associated with pyelonephritis, cystitis, and other chronic urinary tract infections; also for infected residual urine sometimes accompanying neurologic diseases. When used as recommended, methenamine mandelate, USP is particularly suitable for long-term therapy because of its safety and because resistance to the nonspecific bactericidal action of formaldehyde does not develop. Pathogens resistant to other antibacterial agents may respond to methenamine mandelate, USP because of the nonspecific effect of formaldehyde formed in an acid urine. Prophylactic Use Rationale:Urine is a good culture medium for many urinary pathogens. Inoculation by a few organisms (relapse or reinfection) may lead to bacteriuria in susceptible individuals. Thus, the rationale of management in recurring urinary tract infection (bacteriuria) is to change the urine from a growth-supporting to a growth-inhibiting medium. There is a growing body of evidence that long-term administration of methenamine mandelate, USP can prevent the recurrence of bacteriuria in patients with chronic pyelonephritis. T herapeutic Use Rationale:Methenamine mandelate, USP helps to sterilize the urine, and in some situations in which underlying pathologic conditions prevent sterilization by any means, it can help to suppress the bacteriuria. Methenamine mandelate, USP should not be used alone for acute infections with parenchymal involvement causing systemic symptoms such as chi ls and fever. A thorough diagnostic investigation as a part of the overall management of the urinary tract infection should accompany the use of methenamine mandelate, USP.

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 product is billed per "ML" milliliter and contains an estimated amount of 473 billable units per package. 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.

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. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 473 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)
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.