Prescription drug · ANDA
Eplerenone NDC 51991-877
Eplerenone 25 mg/1 · Tablet, Film coated · Oral · Breckenridge Pharmaceutical, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51991-877-11 | 5199108771151991087711 | 10 BLISTER PACK in 1 CARTON (51991-877-11) / 10 TABLET, FILM COATED in 1 BLISTER PACK (51991-877-99)Marketed from Sep 18, 2018 | |
| 51991-877-33 | 5199108773351991087733 | 30 TABLET, FILM COATED in 1 BOTTLE (51991-877-33)Marketed from Sep 18, 2018 | |
| 51991-877-90 | 5199108779051991087790 | 90 TABLET, FILM COATED in 1 BOTTLE (51991-877-90)Marketed from Sep 18, 2018 |
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, Film coated
- Route
- Oral
- Labeler
- Breckenridge Pharmaceutical, Inc.NDC labeler code 51991
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 208283
- Marketing start
- Listing expires
- Other FDA classes
- Aldosterone Antagonists (Mechanism)
- Identifiers
- Product ID 51991-877_546c0ded-8c22-4840-b369-a3029dedc299SPL ID 546c0ded-8c22-4840-b369-a3029dedc299SPL set ID e2a51c12-bdc2-4b3b-8e9e-bf363c2817edRxCUI 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
N451991087711followed by a unit qualifier and the quantityPackage 51991-0877-11. 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 Tablets are 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 Tablets are 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 …
Excerpt only. Read the full label for complete information.
About NDC 51991-877
- What is NDC 51991-877?
- 51991-877 is the product NDC for Eplerenone, Eplerenone 25 mg/1 tablet, film coated, listed with the FDA by Breckenridge Pharmaceutical, Inc.. It has 3 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?
- Breckenridge Pharmaceutical, Inc., NDC labeler code 51991. 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 50 mg/1 | Tablet, Film coatedOral | Mylan Pharmaceuticals Inc. | 59762-1108 | 59762-1108-0159762-1108-02 |
| 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 |
Other NDCs under ANDA 208283
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 50 mg/1 | Tablet, Film coatedOral | Breckenridge Pharmaceutical, Inc. | 51991-878 |
| Eplerenone | Eplerenone 25 mg/1 | Tablet, Film coatedOral | American Health Packaging | 60687-451 |