Active ingredient
Spironolactone
180 finished FDA listings contain Spironolactone as their only active ingredient; 13 combination products also contain it.
FDA NDC Directory
- Ingredient names as written by FDA
- SPIRONOLACTONE
- Dosage forms
- Suspension, Tablet, Tablet, Coated, Tablet, Film Coated
- Routes
- Oral
- Manufacturers / labelers
- 43
- Strengths listed
- 100 mg/1 · 25 mg/1 · 25 mg/5ml · 50 mg/1
- Brand names in FDA listings
- Aldactone
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 9997
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 012151 | PFIZER | 1960-01-21 | 3 |
| ANDA 089424 | SUN PHARM INDUSTRIES | 1986-07-23 | 39 |
| ANDA 040424 | MYLAN | 2001-08-20 | 12 |
| ANDA 040750 | OXFORD PHARMS | 2006-08-29 | 34 |
| ANDA 091426 | AMNEAL PHARMS | 2010-07-02 | 10 |
| ANDA 202187 | AUROBINDO PHARMA | 2014-03-06 | 19 |
| ANDA 203253 | JUBILANT GENERICS | 2014-04-23 | 14 |
| ANDA 203512 | ACCORD HLTHCARE | 2016-09-19 | 20 |
| NDA 209478 | CMP DEV LLC | 2017-08-04 | 4 |
| ANDA 205936 | ZYDUS PHARMS | 2018-07-18 | 17 |
| ANDA 215572 | AMNEAL | 2023-09-05 | 1 |
| ANDA 219494 | GRAVITI PHARMS | 2025-01-23 | 3 |
| ANDA 218085 | HETERO LABS LTD III | 2025-02-21 | 1 |
| ANDA 217761 | ANNORA PHARMA | 2025-07-25 | 3 |
Official labeling on DailyMed
- SPIRONOLACTONE TABLET, FILM COATED [REMEDYREPACK INC.] · version 5 · 2026-09-16
- SPIRONOLACTONE TABLET [BRYANT RANCH PREPACK] · version 11 · 2026-09-10
- SPIRONOLACTONE TABLET [BRYANT RANCH PREPACK] · version 16 · 2026-09-10
- SPIRONOLACTONE TABLET [BRYANT RANCH PREPACK] · version 110 · 2026-09-10
- SPIRONOLACTONE TABLET, FILM COATED [BRYANT RANCH PREPACK] · version 13 · 2026-09-10
- SPIRONOLACTONE TABLET [REMEDYREPACK INC.] · version 2 · 2026-09-10
- SPIRONOLACTONE TABLET, FILM COATED [BRYANT RANCH PREPACK] · version 11 · 2026-09-10
- SPIRONOLACTONE TABLET, FILM COATED [BRYANT RANCH PREPACK] · version 22 · 2026-09-10
- SPIRONOLACTONE TABLET [BRYANT RANCH PREPACK] · version 11 · 2026-09-10
- SPIRONOLACTONE TABLET, FILM COATED [BRYANT RANCH PREPACK] · version 110 · 2026-09-10
- SPIRONOLACTONE TABLET, FILM COATED [BRYANT RANCH PREPACK] · version 11 · 2026-09-10
- SPIRONOLACTONE TABLET, FILM COATED [CARDINAL HEALTH 107, LLC] · version 22 · 2026-09-02
Showing the 12 most recent of 129 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.