Active ingredient
Amiloride
3 finished FDA listings contain Amiloride as their only active ingredient; 2 combination products also contain it.
FDA NDC Directory
- Ingredient names as written by FDA
- AMILORIDE, AMILORIDE HYDROCHLORIDE, AMILORIDE HYDROCHLORIDE ANHYDROUS
- Dosage forms
- Tablet
- Routes
- Oral
- Manufacturers / labelers
- 3
- Strengths listed
- 5 mg/1
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 644
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| NDA 018200 | PADAGIS US | 1981-10-05 | 1 |
| ANDA 070346 | PH HEALTH | 1986-01-22 | 1 |
| ANDA 079133 | SIGMAPHARM LABS LLC | 2009-01-30 | 1 |
Official labeling on DailyMed
- AMILORIDE HYDROCHLORIDE TABLET [PAR HEALTH USA, LLC] · version 13 · 2026-08-07
- AMILORIDE HYDROCHLORIDE TABLET [PADAGIS US LLC] · version 7 · 2024-11-25
- AMILORIDE HYDROCHLORIDE TABLET [SIGMAPHARM LABORATORIES, LLC] · version 2 · 2023-01-11
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.