Quick answers
- What is Eplerenone used for?
- The FDA-approved label (Inspra, Viatris Specialty LLC, June 23, 2025) says: “INSPRA 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. • The treatment of hypertension in adults, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Eplerenone have a boxed warning?
- No. None of the 12 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Eplerenone?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Eplerenone been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Eplerenone?
- 11 companies list prescription products of Eplerenone in the FDA NDC Directory, including AvKARE, Accord Healthcare Inc. and Mylan Pharmaceuticals Inc..
What Eplerenone is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
INSPRA 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. • The treatment of hypertension in adults, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. …
— FDA label: Inspra, Viatris Specialty LLC, effective June 23, 2025. Read the full label on DailyMed →
The FDA has 12 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 12 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet, film coated · Tablet, coated · Tablet |
|---|---|
| Route | Oral |
| Prescription products | 21 in the FDA NDC Directory |
| Brand names | Inspra |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| eplerenone 25 mg tablet | Generic | $0.3314 per tablet |
| eplerenone 25 mg tablet, coated | Generic | $0.3314 per tablet |
| eplerenone 25 mg tablet, film coated | Generic | $0.3314 per tablet |
| eplerenone 50 mg tablet | Generic | $0.4714 per tablet |
| eplerenone 50 mg tablet, coated | Generic | $0.4714 per tablet |
| eplerenone 50 mg tablet, film coated | Generic | $0.4714 per tablet |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- AvKARE2 products
- Accord Healthcare Inc.2 products
- Mylan Pharmaceuticals Inc.2 products
- Proficient Rx LP2 products
- Westminster Pharmaceuticals, LLC2 products
- Camber Pharmaceuticals, Inc.2 products
- Viatris Specialty LLC2 products
- Rising Pharma Holdings, Inc.2 products
- Breckenridge Pharmaceutical, Inc.2 products
- Bryant Ranch Prepack2 products
- American Health Packaging1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA021437 INSPRA | Upjohn | September 27, 2002 | 10, latest June 16, 2025 2025: Labeling · 2018: Labeling · 2016: Labeling |
Generic approvals (5)
- ANDA206922Accord Hlthcare · July 13, 2017
- ANDA208283Breckenridge · September 14, 2018
- ANDA207842Everest Lifesciences · October 25, 2021
- ANDA214663Rising · March 23, 2022
- ANDA213812Annora Pharma · June 2, 2023
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 351256, 351257, 402105, 402106 |
|---|---|
| SPL set ID of the quoted label | 1a52bedc-8e2c-4116-a296-a87770676b4a |
| FDA labels (SPL) | 12 |
| FDA applications | NDA021437, 5 ANDA |
| Active ingredients (FDA) | EPLERENONE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Inspra, Viatris Specialty LLC, effective June 23, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →