Prescription drug · ANDA
Eplerenone NDC 63629-9414
Eplerenone 25 mg/1 · Tablet, Film coated · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63629-9414-1 | 63629941401 | 90 TABLET, FILM COATED in 1 BOTTLE (63629-9414-1)Marketed from Jul 27, 2022 | |
| 63629-9414-2 | 63629941402 | 30 TABLET, FILM COATED in 1 BOTTLE (63629-9414-2)Marketed from Jul 27, 2022 |
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 — 25 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Bryant Ranch PrepackNDC labeler code 63629
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 206922
- Marketing start
- Listing expires
- Other FDA classes
- Aldosterone Antagonists (Mechanism)
- Identifiers
- Product ID 63629-9414_cddd14b9-541c-4a14-9241-11c513bda59dSPL ID cddd14b9-541c-4a14-9241-11c513bda59dSPL set ID bcd7595f-700f-48ba-bf83-05a995ce0731RxCUI 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
N463629941401followed by a unit qualifier and the quantityPackage 63629-9414-01. 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: The treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctio( 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, including, as approp…
Excerpt only. Read the full label for complete information.
About NDC 63629-9414
- What is NDC 63629-9414?
- 63629-9414 is the product NDC for Eplerenone, Eplerenone 25 mg/1 tablet, film coated, listed with the FDA by Bryant Ranch Prepack. 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?
- Bryant Ranch Prepack, NDC labeler code 63629. 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 206922
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 | Accord Healthcare, Inc. | 16729-293 |
| Eplerenone | Eplerenone 50 mg/1 | Tablet, Film coatedOral | Accord Healthcare, Inc. | 16729-294 |