Regulatory PathRegulatory requirements compared

Active substance

Metolazone

Open in the medicines table

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

ProductStrengthForm · routeApplicantStatusFirst approved
METOLAZONE5MG; 10MGtablet · oralSANDOZPrescription19 Dec 2003
METOLAZONE2.5MGtablet · oralSANDOZPrescription19 Dec 2003
METOLAZONE2.5MG; 5MG; 10MGtablet · oralMYLANPrescription23 Dec 2003
METOLAZONE10MGtablet · oralROXANEPrescription29 Apr 2004
METOLAZONE2.5MG; 5MG; 10MGtablet · oralALEMBICPrescription2 Dec 2020
METOLAZONE2.5MG; 5MG; 10MGtablet · oralINNOGENIXPrescription30 Mar 2021
METOLAZONE2.5MG; 5MG; 10MGtablet · oralUNICHEMPrescription30 Mar 2021
METOLAZONE2.5MG; 5MG; 10MGtablet · oralRUBICON RESEARCHPrescription20 Aug 2021
METOLAZONE2.5MG; 5MG; 10MGtablet · oralRENATAPrescription24 Oct 2022
METOLAZONE2.5MG; 5MG; 10MGtablet · oralNE RX PHARMAPrescription25 Oct 2022
METOLAZONE2.5MG; 5MG; 10MGtablet · oralACERTIS PHARMSPrescription17 Apr 2024
ZAROXOLYN2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**tablet · oralI3 PHARMSDiscontinued27 Nov 1973
DIULO2.5MG; 5MG; 10MGtablet · oralGD SEARLE LLCDiscontinued24 Feb 1981
MYKROX0.5MGtablet · oralCHARTWELL MOLECULARDiscontinued30 Oct 1987
METOLAZONE2.5MG; 5MG; 10MGtablet · oralANI PHARMSDiscontinued24 Dec 2003
METOLAZONE10MGtablet · oralROXANEDiscontinued29 Apr 2004
METOLAZONE10MGtablet · oralWATSON LABSDiscontinued21 Jul 2004
METOLAZONE2.5MG; 5MG; 10MGtablet · oralMICRO LABSDiscontinued6 Nov 2024

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
ZAROXOLYN008884002.5 MGTABLET · ORALSANOFI-AVENTIS CANADA INC

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACMETOLAZONE 10 MG TABLET$0.38134per EA23 Sep 2026
US NADACMETOLAZONE 2.5 MG TABLET$0.23282per EA23 Sep 2026
US NADACMETOLAZONE 5 MG TABLET$0.23919per EA23 Sep 2026
NHS Drug TariffMetolazone 5mg tablets£110.0020 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.

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.