Prescription drug · ANDA
Eplerenone NDC 42291-454
Eplerenone 25 mg/1 · Tablet, Coated · Oral · AvKARE
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42291-454-90 | 42291045490 | 90 TABLET, COATED in 1 BOTTLE (42291-454-90)Marketed from Mar 3, 2022 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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 — 25 mg/1
- Dosage form
- Tablet, Coated
- Route
- Oral
- Labeler
- AvKARE
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207842
- Marketing start
- Listing expires
- Other FDA classes
- Aldosterone Antagonists (Mechanism)
- Identifiers
- Product ID 42291-454_485d3fe4-eadd-a4dc-e063-6294a90ab9f0SPL ID 485d3fe4-eadd-a4dc-e063-6294a90ab9f0SPL set ID d953457e-0aff-6c38-e053-2995a90a7d32RxCUI 351256, 351257UNII 6995V82D0B
- 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
N442291045490followed by a unit qualifier and the quantityPackage 42291-0454-90. 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 patients with symptomatic heart failure with reduced ejection fraction (HFrEF) after an acute myocardial infarction. ( 1.1 ) The treatment of hypertension, 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 tablets are indicated to improve survival of stable patients with symptomatic heart failure with reduced ejection fraction (≤40%) (HFrEF) after an acute myocardial infarction (MI) . 1.2 Hypertension Eplerenone tablets are indicated for the…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 207842
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, CoatedOral | Proficient Rx LP | 71205-863 |
| Eplerenone | Eplerenone 50 mg/1 | Tablet, CoatedOral | Proficient Rx LP | 71205-864 |
| Eplerenone | Eplerenone 25 mg/1 | Tablet, CoatedOral | Bryant Ranch Prepack | 71335-2355 |
| Eplerenone | Eplerenone 50 mg/1 | Tablet, CoatedOral | AvKARE | 42291-455 |
| Eplerenone | Eplerenone 50 mg/1 | Tablet, CoatedOral | Westminster Pharmaceuticals, LLC | 69367-308 |
| Eplerenone | Eplerenone 25 mg/1 | Tablet, CoatedOral | Westminster Pharmaceuticals, LLC | 69367-307 |
- openFDA data updated
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Reference information only. Verify codes and billing rules against the applicable payer and official source before submitting a claim. How Med-Code handles data.