Prescription drug · ANDA
Eplerenone NDC 60687-451
Eplerenone 25 mg/1 · Tablet, Film coated · Oral · American Health Packaging
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 60687-451-21 | 6068704512160687045121 | 30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-451-21) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-451-11)Marketed from Jun 13, 2019 |
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
- American Health PackagingNDC labeler code 60687
- 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 60687-451_5a1e5d3d-eb1f-d60d-e063-6294a90a812fSPL ID 5a1e5d3d-eb1f-d60d-e063-6294a90a812fSPL set ID 3a3047f2-0155-4a07-955f-839a312cf879RxCUI 351256UNII 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
N460687045121followed by a unit qualifier and the quantityPackage 60687-0451-21. 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: 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 ). 1.2 Hypertension Eplerenone Tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular (CV) events, primarily strokes and MI. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes. Control of high blood pressure should be part of comprehensive CV risk management, includi…
Excerpt only. Read the full label for complete information.
About NDC 60687-451
- What is NDC 60687-451?
- 60687-451 is the product NDC for Eplerenone, Eplerenone 25 mg/1 tablet, film coated, listed with the FDA by American Health Packaging. It has 1 package NDC, 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?
- American Health Packaging, NDC labeler code 60687. 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 25 mg/1 | Tablet, Film coatedOral | Breckenridge Pharmaceutical, Inc. | 51991-877 |
| Eplerenone | Eplerenone 50 mg/1 | Tablet, Film coatedOral | Breckenridge Pharmaceutical, Inc. | 51991-878 |