Eplerenone
- Product NDC
- 0185-5368
- 11-digit product format
- 001855368
- Labeler code
- 0185
- Product ID
- 0185-5368_697e0d84-e7d2-400e-baab-2ca055e4c6a4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Eplerenone
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Eon Labs, Inc.
- Application
- ANDA078510
- Marketing category
- ANDA
- Marketing start
- 2008-08-01
- Marketing end
- 0000-00-00
- Substance
- EPLERENONE
- Active strength
- 25 mg/1
- Pharmacologic classes
- Aldosterone Antagonist [EPC], Aldosterone Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| EPLERENONE | ACTIVE INGREDIENT | 6995V82D0B | EPLERENONE TABLET [PHYSICIANS TOTAL CARE, INC.] | 2 | |
| EPLERENONE | ACTIVE MOIETY | 6995V82D0B | EPLERENONE TABLET [PHYSICIANS TOTAL CARE, INC.] | 2 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | EPLERENONE TABLET [PHYSICIANS TOTAL CARE, INC.] | 2 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | EPLERENONE TABLET [PHYSICIANS TOTAL CARE, INC.] | 2 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | EPLERENONE TABLET [PHYSICIANS TOTAL CARE, INC.] | 2 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | EPLERENONE TABLET [PHYSICIANS TOTAL CARE, INC.] | 2 | |
| POLYETHYLENE GLYCOL | INACTIVE INGREDIENT | 3WJQ0SDW1A | EPLERENONE TABLET [PHYSICIANS TOTAL CARE, INC.] | 2 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | EPLERENONE TABLET [PHYSICIANS TOTAL CARE, INC.] | 2 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | EPLERENONE TABLET [PHYSICIANS TOTAL CARE, INC.] | 2 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | EPLERENONE TABLET [PHYSICIANS TOTAL CARE, INC.] | 2 | |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0185-5368-09 | 00185536809 | 90 TABLET in 1 BOTTLE (0185-5368-09) | 90 tablet | 2008-08-01 | 0000-00-00 | No | No | Current |
| 0185-5368-30 | 00185536830 | 30 TABLET in 1 BOTTLE (0185-5368-30) | 30 tablet | 2008-08-01 | 0000-00-00 | No | No | Current |