NDC 13925-107 Methenamine Mandelate

View Dosage, Usage, Ingredients, Routes, UNII

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
NDC Product Code:
13925-107
Proprietary Name:
Methenamine Mandelate
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Code:
13925
Start Marketing Date: [9]
02-01-2010
Listing Expiration Date: [11]
12-31-2023
Exclude Flag: [12]
I
Code Navigator:

Product Characteristics

Color(s):
BLUE (C48333)
Shape:
OVAL (C48345)
Size(s):
19 MM
Imprint(s):
ERTH;1000
Score:
2

Code Structure Chart

Product Details

What is NDC 13925-107?

The NDC code 13925-107 is assigned by the FDA to the product Methenamine Mandelate which is product labeled by Seton Pharmaceuticals. The product's dosage form is . The product is distributed in a single package with assigned NDC code 13925-107-01 100 tablet, film coated in 1 bottle . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

What are the uses for Methenamine Mandelate?

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.

Which are Methenamine Mandelate UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are Methenamine Mandelate Inactive Ingredients UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

What is the NDC to RxNorm Crosswalk for Methenamine Mandelate?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

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Patient Education

Methenamine


Methenamine, an antibiotic, eliminates bacteria that cause urinary tract infections. It usually is used on a long-term basis to treat chronic infections and to prevent recurrence of infections. Antibiotics will not work for colds, flu, or other viral infections. This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.
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Product Footnotes

[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

[9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

[11] What is the Listing Expiration Date? - This is the date when the listing record will expire if not updated or certified by the product labeler.

[12] What is the NDC Exclude Flag? - This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".