Prescription drug · NDA AUTHORIZED GENERIC
Eplerenone NDC 59762-1108
Eplerenone 50 mg/1 · Tablet, Film coated · Oral · Mylan Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 59762-1108-1 | 59762110801 | 30 TABLET, FILM COATED in 1 BOTTLE (59762-1108-1)Marketed from Nov 14, 2024 | |
| 59762-1108-2 | 59762110802 | 90 TABLET, FILM COATED in 1 BOTTLE (59762-1108-2)Marketed from Nov 5, 2025 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Eplerenone
- Generic name (nonproprietary)
- eplerenone
- Active ingredients
- Eplerenone — 50 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Mylan Pharmaceuticals Inc.NDC labeler code 59762
- Product type
- Prescription drug
- Marketing category
- NDA authorized genericApplication NDA 021437
- Marketing start
- Listing expires
- Other FDA classes
- Aldosterone Antagonists (Mechanism)
- Identifiers
- Product ID 59762-1108_b4bf45ee-6524-4a9d-9d7d-91886e32ee72SPL ID b4bf45ee-6524-4a9d-9d7d-91886e32ee72SPL set ID 4286699b-2320-4d3d-831c-32085f36fb67RxCUI 351256, 351257UNII 6995V82D0BUPC 0359762110725, 0359762110817
- Pharmacologic class
- Aldosterone Antagonist
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N459762110801followed by a unit qualifier and the quantityPackage 59762-1108-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
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. ( 1.1 ) • 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. ( 1.2 ) 1.1 Heart Failure Post-Myocardial Infarction Eplerenone is indicated to improve survival of stable adult patients with symptomatic heart failure with reduced ejection fraction (≤ 40%) (HFrEF) after an acute myocardial infarction (MI). 1.2 Hypertension Eplerenone is indicated…
Excerpt only. Read the full label for complete information.
About NDC 59762-1108
- What is NDC 59762-1108?
- 59762-1108 is the product NDC for Eplerenone, Eplerenone 50 mg/1 tablet, film coated, listed with the FDA by Mylan Pharmaceuticals Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Eplerenone.
- What is the active ingredient?
- Eplerenone.
- Who is the labeler?
- Mylan Pharmaceuticals Inc., NDC labeler code 59762. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Eplerenone?
- 18 other product NDCs are listed under this name. See all Eplerenone NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Eplerenone products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Eplerenone | Eplerenone 25 mg/1 | Tablet, Film coatedOral | Mylan Pharmaceuticals Inc. | 59762-1107 | 59762-1107-0259762-1107-03 |
| Eplerenone | Eplerenone 25 mg/1 | TabletOral | Rising Pharma Holdings, Inc. | 16571-173 | 16571-0173-0316571-0173-09 |
| Eplerenone | Eplerenone 50 mg/1 | TabletOral | Rising Pharma Holdings, Inc. | 16571-174 | 16571-0174-0316571-0174-09 |
| Eplerenone | Eplerenone 25 mg/1 | Tablet, Film coatedOral | Camber Pharmaceuticals, Inc. | 31722-049 | 31722-0049-3031722-0049-90 |
| Eplerenone | Eplerenone 50 mg/1 | Tablet, Film coatedOral | Camber Pharmaceuticals, Inc. | 31722-050 | 31722-0050-3031722-0050-90 |
| Eplerenone | Eplerenone 25 mg/1 | Tablet, CoatedOral | AvKARE | 42291-454 | 42291-0454-90 |
| Eplerenone | Eplerenone 50 mg/1 | Tablet, CoatedOral | AvKARE | 42291-455 | 42291-0455-90 |
| Eplerenone | Eplerenone 25 mg/1 | Tablet, CoatedOral | Westminster Pharmaceuticals, LLC | 69367-307 | 69367-0307-0969367-0307-30 |
| Eplerenone | Eplerenone 50 mg/1 | Tablet, CoatedOral | Westminster Pharmaceuticals, LLC | 69367-308 | 69367-0308-0969367-0308-30 |
| Eplerenone | Eplerenone 50 mg/1 | Tablet, CoatedOral | Proficient Rx LP | 71205-864 | 71205-0864-0071205-0864-1171205-0864-30+5 more |
Other NDCs under NDA 021437
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Eplerenone | Eplerenone 25 mg/1 | Tablet, Film coatedOral | Mylan Pharmaceuticals Inc. | 59762-1107 |
| Inspraeplerenone | Eplerenone 25 mg/1 | Tablet, Film coatedOral | Viatris Specialty LLC | 58151-142 |
| Inspraeplerenone | Eplerenone 50 mg/1 | Tablet, Film coatedOral | Viatris Specialty LLC | 58151-143 |