FDA Orange Book · active-ingredient family
Amiloride hydrochloride
Amiloride hydrochloride: 1 brand, 3 generics; first approved Jan 22, 1986; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 3 ANDA applications approved.
Brands (NDA)
1
Generics (ANDA)
3
Listed patents
0
Presentations
4
Brand (NDA) products
Originator applications
- MIDAMORRLDPADAGIS USNDA 018200—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Rx AB
Generic (ANDA) products (3)
Abbreviated applications
- AMILORIDE HYDROCHLORIDECHARTWELL RXANDA 2041802015
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued — - AMILORIDE HYDROCHLORIDESIGMAPHARM LABS LLCANDA 0791332009
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Rx AB - AMILORIDE HYDROCHLORIDERSPH HEALTHANDA 0703461986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Rx AB
Listed patents
Orange Book patent file
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.
Approval history
FDA approval span
First approval
41 yr 2 mo ago
Most recent approval
11 yr 2 mo ago
Approvals span 1986–2015 across 4 FDA applications.
Brand (NDA) 125%
Generic (ANDA) 375%
Amiloride hydrochloride: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
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- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
