Methenamine Hippurate Tablet
NDC Package 70685-050-01

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

Package Information

Methenamine Hippurate tablets is methenamine is used to prevent or control returning urinary tract infections caused by certain bacteria. This formulation utilizes a tablet delivery system. Marketed by Esjay Pharma Llc, this product is identified by NDC 70685-050 and is authorized under FDA application NDA017681.

Identification & Billing

NDC Package Code
70685-050-01
Package Description
100 TABLET in 1 BOTTLE
Product Code
70685-050
11-Digit Billing Format
70685005001
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Methenamine Hippurate
Non-Proprietary Name
Methenamine Hippurate
Substance Name
Methenamine Hippurate
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
METHENAMINE HIPPURATE 1 g/1
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
Esjay Pharma Llc
Product Type
Human Prescription Drug
FDA Application #
NDA017681
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
01-16-2025
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 70685-050-01 identifies a specific commercial package of 100 tablet in 1 bottle of Methenamine Hippurate, a human prescription drug labeled by Esjay Pharma Llc. This tablet is formulated for oral use and contains methenamine hippurate 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 Esjay Pharma Llc on January 16, 2025. The current certification is valid through December 31, 2026.

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 Esjay Pharma Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70685005001. 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)
70685-050-01
11-Digit CMS (5-4-2)
70685-0050-01

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