Regulatory PathRegulatory requirements compared

Active substance

Methenamine

Open in the medicines table

US FDA United States — FDA approvals (Drugs@FDA)

ProductStrengthForm · routeApplicantStatusFirst approved
UREX1GMtablet · oralQUAGENPrescription5 Jul 1967
HIPREX1GMtablet · oralESJAY PHARMAPrescription9 Sep 1976
METHENAMINE HIPPURATE1GMtablet · oralAUROBINDO PHARMA LTDPrescription5 Jul 2016
METHENAMINE HIPPURATE1GMtablet · oralMICRO LABSPrescription1 Aug 2019
METHENAMINE HIPPURATE1GMtablet · oralINGENUS PHARMS LLCPrescription27 Nov 2020
METHENAMINE HIPPURATE1GMtablet · oralJUBILANT CADISTAPrescription1 Dec 2023
METHENAMINE HIPPURATE1GMtablet · oralZYDUS LIFESCIENCESPrescription10 Mar 2025
METHENAMINE HIPPURATE1GMtablet · oralIMPAX LABS INCDiscontinued20 Jun 2003

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACMETHENAMINE HIPP 1 GM TABLET$0.31261per EA30 Sep 2026
US NADACMETHENAMINE MAND 1 GM TABLET$2.60435per EA23 Sep 2026
US NADACMETHENAMINE MAND 500 MG TABLET$1.36088per EA23 Sep 2026
NHS Drug TariffMethenamine hippurate 1g tablets£32.2160 tablet1 Oct 2026

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

Safety signals and safety-related labeling changes

All safety entries for methenamine →

Combinations containing Methenamine

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.