Amiloride Hydrochloride

For significant cardiac arrhythmias. Sold as Midamor. Every FDA application for this active ingredient: 1 branded and 3 generic.

As of Nov 15, 2026, FDA lists 4 applications for Amiloride Hydrochloride (sold as Midamor), first approved Oct 5, 1981, with 0 new uses approved and 0 published complete response letters.

First approved: Oct 5, 1981
Applications: 4
New uses approved: 0
Complete response letters: 0
Medicare spending, 2025: $2.0M

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name

Product	Part	Spending, 2025	Change	Beneficiaries
Amiloride HCl	Part D	$2.0M	+1%	28,375

What Pharmacies Pay

Median price per unit across package codes in CMS's weekly NADAC survey, Nov 11, 2026, before rebates; see every drug's price change

AMILORIDE HCL 5 MG TABLET: $0.196 per unitGeneric · +1% in a year

Clinical Trials

8 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


Vertebrobasilar Dolichoectasia Treatment With AmilorideVertebrobasilar Dolichoectasia · Huashan Hospital	Phase 2	Not yet recruiting	Jun 8, 2026
Beneficial Effect of Amiloride on Progression of Chronic Kidney DiseaseChronic Kidney Disease(CKD), Proteinuria · Odense University Hospital	Phase 2	Recruiting	Apr 11, 2025
ARX788 for Treating Patients With HER2-low Locally Advanced Unresectable or Metastatic Breast CancerHER2 Low Breast Carcinoma, Triple Negative Breast Cancer · Laura Huppert, MD, BA	Phase 2	Recruiting	Jan 25, 2024
Mechanisms of Diuretic Resistance in Heart Failure, Aim 3Heart Failure, Diuretic Resistance · Yale University	Phase 1	Recruiting	Jan 17, 2024
Mechanisms of Diuretic Resistance in Heart Failure, Aim 2Heart Failure · Yale University	Phase 1	Recruiting	Mar 3, 2023
AMIloride for the Treatment of Nephrogenic Diabetes Insipidus for Patients With Bipolar Disorder Treated With LithiumBipolar Disorder · Assistance Publique - Hôpitaux de Paris	Phase 4	Active, not recruiting	Sep 16, 2021
Acid-Sensing Ion Channel and Migraine Disease Proof of Concept Study on the Efficacy of Amiloride in the Prophylaxis of Migraine AuraMigraine With Aura · Centre Hospitalier Universitaire de Nice	Phase 2	Recruiting	Aug 21, 2019
Ivacaftor for Acquired CFTR Dysfunction in Chronic Rhinosinusitis (EDSPD Protocol)CRS · University of Alabama at Birmingham	—	Active, not recruiting	Dec 19, 2016

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


Oct 5, 1981	MidamorNDA 18200 · New molecular entity	Padagis US	26	Marketed
Jan 22, 1986	Amiloride HydrochlorideANDA 70346	Ph Health	9	Marketed
Jan 30, 2009	Amiloride HydrochlorideANDA 79133	Sigmapharm Labs LLC	0	Marketed
Aug 7, 2015	Amiloride HydrochlorideANDA 204180	Chartwell Rx	0	Discontinued

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA