Last Updated: November 9, 2026

Details for New Drug Application (NDA): 079133

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NDA 079133 describes AMILORIDE HYDROCHLORIDE, which is a drug marketed by Chartwell Rx, Ph Health, Sigmapharm Labs Llc, Barr, Rising, Teva, and Watson Labs, and is included in eight NDAs. It is available from two suppliers. Additional details are available on the AMILORIDE HYDROCHLORIDE profile page.

The generic ingredient in AMILORIDE HYDROCHLORIDE is amiloride hydrochloride; hydrochlorothiazide. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the amiloride hydrochloride; hydrochlorothiazide profile page.

Summary for 079133

Tradename:	AMILORIDE HYDROCHLORIDE
Applicant:	Sigmapharm Labs Llc
Ingredient:	amiloride hydrochloride
Patents:	0

Pharmacology for NDA: 079133

Physiological Effect	Decreased Renal K+ Excretion Increased Diuresis

Medical Subject Heading (MeSH) Categories for 079133

Acid Sensing Ion Channel Blockers
Diuretics
Epithelial Sodium Channel Blockers

Suppliers and Packaging for NDA: 079133

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
AMILORIDE HYDROCHLORIDE	amiloride hydrochloride	TABLET;ORAL	079133	ANDA	Sigmapharm Laboratories, LLC	42794-005	42794-005-02	100 TABLET in 1 BOTTLE (42794-005-02)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	5MG
Approval Date:	Jan 30, 2009	TE:	AB	RLD:	No

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