Is there a generic for Amiloride hydrochloride?

Yes. The FDA Orange Book lists 3 approved generic (ANDA) applications for Amiloride hydrochloride, referencing the brand MIDAMOR. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Amiloride hydrochloride?

MIDAMOR (NDA 018200, PADAGIS US) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Amiloride hydrochloride are approved?

Amiloride hydrochloride is approved in the following dosage form: tablet.

FDA Orange Book · active-ingredient family

Amiloride hydrochloride

Amiloride hydrochloride is approved as 1 brand and 3 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:MIDAMOR · NDA 018200

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · tablet

Product	Applicant	Application	TE	Approved
MIDAMORRLD	PADAGIS US	NDA 018200	AB	Approved Prior to Jan 1, 1982

Generic (ANDA) products (3)

Product	Applicant	Application	TE	Approved
AMILORIDE HYDROCHLORIDE	CHARTWELL RX	ANDA 204180	—	Aug 07, 2015
AMILORIDE HYDROCHLORIDE	SIGMAPHARM LABS LLC	ANDA 079133	AB	Jan 30, 2009
AMILORIDE HYDROCHLORIDE	PH HEALTH	ANDA 070346	AB	Jan 22, 1986

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Amiloride hydrochloride — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

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