Drug Information

Product NDC: 49973-011

Proprietary Name: Azo Urinary Tract Defense

Non Proprietary Name: Methenamine, Sodium salicylate

Active Ingredient(s):
  • 162 mg/1 METHENAMINE;
  • 162.5 mg/1 SODIUM SALICYLATE

Administration Route(s): ORAL

Dosage Form(s): TABLET

Labeler Information

Labeler Name: i-Health, Inc.
Product Type: HUMAN OTC DRUG
FDA Application Number:
Start Marketing Date:11/6/2015

Package Information

No. Package Code Package Description Billing Unit
149973-011-044 TABLET in 1 POUCH (49973-011-04)
249973-011-181 BLISTER PACK in 1 BOX (49973-011-18) > 18 TABLET in 1 BLISTER PACK
349973-011-241 BLISTER PACK in 1 BOX (49973-011-24) > 24 TABLET in 1 BLISTER PACK

NDC Record

Field Name Field Value Definition
PRODUCT NDC49973-011The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PRODUCT TYPE NAMEHUMAN OTC DRUGIndicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
PROPRIETARY NAMEAzo Urinary Tract DefenseThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
PROPRIETARY NAME SUFFIXAntibacterial ProtectionA suffix to the proprietary name, a value here should be appended to the ProprietaryName field to obtain the complete name of the product. This suffix is often used to distinguish characteristics of a product such as extended release (“XR”) or sleep aid (“PM”). Although many companies follow certain naming conventions for suffices, there is no recognized standard.
NON PROPRIETARY NAMEMethenamine, Sodium salicylateThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMETABLETThe translation of the dosage form Code submitted by the firm.
ROUTE NAMEORALThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE11/6/2015This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEUNAPPROVED DRUG OTHERProduct types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
LABELER NAMEi-Health, Inc.Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEMETHENAMINE; SODIUM SALICYLATEThis is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

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This page was last updated on: 7/3/2020