Active ingredient
Eplerenone
21 finished FDA listings contain Eplerenone as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- EPLERENONE
- Dosage forms
- Tablet, Tablet, Coated, Tablet, Film Coated
- Routes
- Oral
- Manufacturers / labelers
- 11
- Strengths listed
- 25 mg/1 · 50 mg/1
- Brand names in FDA listings
- Inspra
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 298869
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 021437 | UPJOHN | 2002-09-27 | 4 |
| ANDA 206922 | ACCORD HLTHCARE | 2017-07-13 | 3 |
| ANDA 208283 | BRECKENRIDGE | 2018-09-14 | 3 |
| ANDA 207842 | WESTMINSTER PHARMS | 2021-10-25 | 7 |
| ANDA 214663 | RISING | 2022-03-23 | 2 |
| ANDA 213812 | ANNORA PHARMA | 2023-06-02 | 2 |
Official labeling on DailyMed
- EPLERENONE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] · version 6 · 2026-09-02
- EPLERENONE TABLET, FILM COATED [BRYANT RANCH PREPACK] · version 104 · 2026-06-26
- EPLERENONE TABLET, FILM COATED [BRECKENRIDGE PHARMACEUTICAL, INC.] · version 8 · 2026-05-07
- EPLERENONE TABLET, FILM COATED [ACCORD HEALTHCARE, INC.] · version 9 · 2026-04-09
- INSPRA (EPLERENONE) TABLET, FILM COATED [VIATRIS SPECIALTY LLC] · version 6 · 2026-02-06
- EPLERENONE TABLET, COATED [AVKARE] · version 4 · 2026-01-16
- EPLERENONE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] · version 46 · 2025-11-17
- EPLERENONE TABLET [RISING PHARMA HOLDINGS, INC.] · version 2 · 2025-07-02
- EPLERENONE TABLET, COATED [BRYANT RANCH PREPACK] · version 1 · 2024-05-29
- EPLERENONE (EPLERENONE) TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.] · version 1 · 2023-06-16
- EPLERENONE TABLET, COATED [PROFICIENT RX LP] · version 1 · 2022-03-29
- EPLERENONE TABLET, COATED [WESTMINSTER PHARMACEUTICALS, LLC] · version 1 · 2021-11-17
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.