Active substance
Eplerenone
- SFDA 2
- US FDA 11
- Health Canada 6
- US price lines 2
- NHS prices 2
- Safety 1
SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|---|---|---|---|---|---|---|
| EPNONE 50 mg Tablet | 50 mg | Film-coated tablet · Oral use | 30 Blister | SAR 61.25 | NCE · Prescription | MSN LABORATORIES PRIVATE LIMITED | Valid |
| Epnone | 25 mg | Film-coated tablet · Oral use | 30 Blister | SAR 35.00 | NCE · Prescription | MSN LABORATORIES PRIVATE LIMITED | Valid |
Indications — CHI Daman Drug Formulary
CHRONIC KIDNEY DISEASE; CONGESTIVE HEART FAILURE; HYPERTENSION; NON-ST WAVE ELEVATED MYOCARDIAL INFARCTION (NSTEMI); PRIMARY ALDOSTERONISM; PULMONARY ARTERIAL HYPERTENSION; ST-WAVE ELEVATED MYOCARDIAL INFARCTION (STEMI)
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| INSPRA | 25MG; 50MG | tablet · oral | UPJOHN | Prescription | 27 Sep 2002 |
| EPLERENONE | 25MG; 50MG | tablet · oral | CHARTWELL RX | Prescription | 30 Jul 2008 |
| EPLERENONE | 25MG; 50MG | tablet · oral | SANDOZ | Prescription | 1 Aug 2008 |
| EPLERENONE | 25MG; 50MG | tablet · oral | ACCORD HLTHCARE | Prescription | 13 Jul 2017 |
| EPLERENONE | 25MG; 50MG | tablet · oral | BRECKENRIDGE | Prescription | 14 Sep 2018 |
| EPLERENONE | 25MG; 50MG | tablet · oral | ADAPTIS | Prescription | 10 Aug 2020 |
| EPLERENONE | 25MG; 50MG | tablet · oral | WESTMINSTER PHARMS | Prescription | 25 Oct 2021 |
| EPLERENONE | 25MG; 50MG | tablet · oral | RISING | Prescription | 23 Mar 2022 |
| EPLERENONE | 25MG; 50MG | tablet · oral | ANNORA PHARMA | Prescription | 2 Jun 2023 |
| INSPRA | 100MG | tablet · oral | UPJOHN | Discontinued | 27 Sep 2002 |
| EPLERENONE | 25MG; 50MG | tablet · oral | ANDAS 5 HOLDING | Discontinued | 2 Feb 2017 |
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|---|---|---|---|
| INSPRA | 02323052 | 25 MG | TABLET · ORAL | BGP PHARMA ULC |
| INSPRA | 02323060 | 50 MG | TABLET · ORAL | BGP PHARMA ULC |
| JAMP EPLERENONE | 02543389 | 25 MG | TABLET · ORAL | JAMP PHARMA CORPORATION |
| JAMP EPLERENONE | 02543397 | 50 MG | TABLET · ORAL | JAMP PHARMA CORPORATION |
| MINT-EPLERENONE | 02471442 | 25 MG | TABLET · ORAL | MINT PHARMACEUTICALS INC |
| MINT-EPLERENONE | 02471450 | 50 MG | TABLET · ORAL | MINT PHARMACEUTICALS INC |
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|---|---|---|---|
| US NADAC | EPLERENONE 25 MG TABLET | $0.30799 | per EA | 23 Sep 2026 |
| US NADAC | EPLERENONE 50 MG TABLET | $0.45044 | per EA | 23 Sep 2026 |
| NHS Drug Tariff | Eplerenone 25mg tablets | £2.22 | 28 tablet | 1 Oct 2026 |
| NHS Drug Tariff | Eplerenone 50mg tablets | £4.37 | 28 tablet | 1 Oct 2026 |
NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.
Safety signals and safety-related labeling changes
- US FDA 16 Jun 2025 INSPRA — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.