EPLERENONE is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Breckenridge Pharmaceutical, Inc.. The primary component is Eplerenone.
| Product ID | 51991-877_0dbe6177-4344-4fc6-ac91-9a9b05570b84 |
| NDC | 51991-877 |
| Product Type | Human Prescription Drug |
| Proprietary Name | EPLERENONE |
| Generic Name | Eplerenone |
| Dosage Form | Tablet, Film Coated |
| Route of Administration | ORAL |
| Marketing Start Date | 2018-09-18 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA208283 |
| Labeler Name | Breckenridge Pharmaceutical, Inc. |
| Substance Name | EPLERENONE |
| Active Ingredient Strength | 25 mg/1 |
| Pharm Classes | Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2020-12-31 |
| Marketing Start Date | 2018-09-18 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA208283 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2018-09-18 |
| Marketing Category | ANDA |
| Application Number | ANDA208283 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2018-09-18 |
| Marketing Category | ANDA |
| Application Number | ANDA208283 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2018-09-18 |
| Marketing Category | ANDA |
| Application Number | ANDA208283 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2018-09-18 |
| Ingredient | Strength |
|---|---|
| EPLERENONE | 25 mg/1 |
| SPL SET ID: | e2a51c12-bdc2-4b3b-8e9e-bf363c2817ed |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0185-5368 | Eplerenone | Eplerenone |
| 0185-5369 | Eplerenone | Eplerenone |
| 0378-1030 | Eplerenone | eplerenone |
| 0378-1031 | Eplerenone | eplerenone |
| 0832-0480 | Eplerenone | Eplerenone |
| 0832-0481 | Eplerenone | Eplerenone |
| 16729-293 | Eplerenone | Eplerenone |
| 16729-294 | Eplerenone | Eplerenone |
| 42254-011 | Eplerenone | Eplerenone |
| 42291-454 | Eplerenone | Eplerenone |
| 42291-455 | Eplerenone | Eplerenone |
| 51991-877 | EPLERENONE | EPLERENONE |
| 51991-878 | EPLERENONE | EPLERENONE |
| 59762-1710 | Eplerenone | eplerenone |
| 68084-948 | Eplerenone | Eplerenone |
| 59762-1720 | Eplerenone | Eplerenone |
| 60505-2652 | Eplerenone | Eplerenone |
| 60505-2651 | Eplerenone | Eplerenone |
| 60687-451 | EPLERENONE | EPLERENONE |
| 70436-098 | eplerenone | eplerenone |
| 70436-099 | eplerenone | eplerenone |
| 0025-1710 | Inspra | eplerenone |
| 0025-1720 | Inspra | eplerenone |
| 21695-797 | Inspra | eplerenone |