Medicine
Eplerenone 50 mg tablet
Eplerenone 50 mg tablet is a generic prescription medicine for oral use, made by 8 labelers, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Store at 25°C (77°F), excursions permitted to 15–30°C (59–86°F).
Key facts
- Active ingredient (INN)
- Eplerenone
- Brand
- Sold under the generic name
- Strength
- 50 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 30 tablets, 90 tablets, 10 blister pack and 19 more
- Manufacturers
- Accord HealthcareIndiaCamber PharmaceuticalsIndiaProficient RxBreckenridge PharmaceuticalMylan PharmaceuticalsRising Pharma HoldingsWestminster PharmaceuticalsAvKARE
- Origin register
- US FDA, United States
- Storage
- Store at 25°C (77°F), excursions permitted to 15–30°C (59–86°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- C03DA04 Eplerenone
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 18 September 2018
- Identifiers
- RxCUI 351256, 351257DailyMed set ID e2a51c12-bdc2-4b3b-8e9e-bf363c2817ed, b0886e4e-5710-4053-9270-4d7de34068e7, 49b9759a-c1b9-4ebe-874b-81fb82a42755 +5NDC 51991-878, 16729-294, 71205-864 +5Application ANDA208283, ANDA206922, ANDA207842 +3
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
Packs from every labeler of this generic presentation.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 30 tablet, film coated in 1 bottle | 16729-294-10 | Accord HealthcareIndia | 9 October 2018 |
| 90 tablet, film coated in 1 bottle | 16729-294-15 | Accord HealthcareIndia | 9 October 2018 |
| 30 tablet, film coated in 1 bottle | 31722-050-30 | Camber PharmaceuticalsIndia | 2 June 2023 |
| 90 tablet, film coated in 1 bottle | 31722-050-90 | Camber PharmaceuticalsIndia | 2 June 2023 |
| 10 blister pack in 1 carton / 10 tablet, film coated in 1 blister pack | 51991-878-11 | Breckenridge Pharmaceutical | 18 September 2018 |
| 30 tablet, film coated in 1 bottle | 51991-878-33 | Breckenridge Pharmaceutical | 18 September 2018 |
| 90 tablet, film coated in 1 bottle | 51991-878-90 | Breckenridge Pharmaceutical | 18 September 2018 |
| 30 tablet, film coated in 1 bottle | 59762-1108-1 | Mylan Pharmaceuticals | 14 November 2024 |
| 90 tablet, film coated in 1 bottle | 59762-1108-2 | Mylan Pharmaceuticals | 5 November 2025 |
| 30 tablet in 1 bottle | 16571-174-03 | Rising Pharma Holdings | 30 September 2024 |
| 90 tablet in 1 bottle | 16571-174-09 | Rising Pharma Holdings | 30 September 2024 |
| 90 tablet, coated in 1 bottle | 42291-455-90 | AvKARE | 3 March 2022 |
| 100 tablet, coated in 1 bottle, plastic | 71205-864-00 | Proficient Rx | 24 March 2022 |
| 1000 tablet, coated in 1 bottle, plastic | 71205-864-11 | Proficient Rx | 24 March 2022 |
| 30 tablet, coated in 1 bottle, plastic | 71205-864-30 | Proficient Rx | 24 March 2022 |
| 500 tablet, coated in 1 bottle, plastic | 71205-864-55 | Proficient Rx | 24 March 2022 |
| 60 tablet, coated in 1 bottle, plastic | 71205-864-60 | Proficient Rx | 24 March 2022 |
| 120 tablet, coated in 1 bottle, plastic | 71205-864-72 | Proficient Rx | 24 March 2022 |
| 180 tablet, coated in 1 bottle, plastic | 71205-864-78 | Proficient Rx | 24 March 2022 |
| 90 tablet, coated in 1 bottle, plastic | 71205-864-90 | Proficient Rx | 24 March 2022 |
| 90 tablet, coated in 1 bottle, plastic | 69367-308-09 | Westminster Pharmaceuticals | 8 November 2021 |
| 30 tablet, coated in 1 bottle, plastic | 69367-308-30 | Westminster Pharmaceuticals | 8 November 2021 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 27 September 2002 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Alternatives
Other makers and brands of Eplerenone 50 mg tablet.
Other strengths and forms of Eplerenone
Clinical summary
Eplerenone is an aldosterone antagonist indicated for improving survival of stable adult patients with symptomatic heart failure with reduced ejection fraction (HFrEF) after an acute myocardial infarction, among other approved uses. MedsAcross supplies Eplerenone for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Read about EplerenoneFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Inspra prescribing information (Viatris Specialty) · U.S. National Library of Medicine, DailyMed
Need Eplerenone 50 mg tablet for your hospital or patient?
Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.