Regulatory PathRegulatory requirements compared

Active substance

Amiloride

Open in the medicines table

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

ProductStrengthForm · routeApplicantStatusFirst approved
MIDAMOR5MGtablet · oralPADAGIS USPrescription5 Oct 1981
AMILORIDE HYDROCHLORIDE5MGtablet · oralPH HEALTHPrescription22 Jan 1986
AMILORIDE HYDROCHLORIDE5MGtablet · oralSIGMAPHARM LABS LLCPrescription30 Jan 2009
AMILORIDE HYDROCHLORIDE5MGtablet · oralCHARTWELL RXDiscontinued7 Aug 2015

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
MIDAMOR022495105.0 MGTABLET · ORALAA PHARMA INC

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACAMILORIDE HCL 5 MG TABLET$0.1901per EA23 Sep 2026
NHS Drug TariffAmiloride 5mg tablets£11.1628 tablet1 Oct 2026
NHS Drug TariffAmiloride 5mg/5ml oral solution sugar free£158.85150 ml1 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.

WHO WHO Model List of Essential Medicines (2025)

  • 16. Diuretics · core
    Oedema; Ascites
    Oral > Solid: 5 mg (hydrochloride)

Combinations containing Amiloride

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.