Eplerenone
- Product NDC
- 16571-173
- 11-digit product format
- 165710173
- Labeler code
- 16571
- Product ID
- 16571-173_9fdff54f-c6fc-4215-a611-5051a7fbae84
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Eplerenone
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Rising Pharma Holdings, Inc.
- Application
- ANDA214663
- Marketing category
- ANDA
- Marketing start
- 2024-09-30
- Substance
- EPLERENONE
- Active strength
- 25 mg/1
- Pharmacologic classes
- Aldosterone Antagonist [EPC], Aldosterone Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Eplerenone
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| EPLERENONE | 25 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 6995V82D0B |
| Rxcui | 351256, 351257 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 16571-173-03 | Eplerenone | 30 in 1 BOTTLE | TABLET | 30 | | 2 |
| 16571-173-09 | Eplerenone | 90 in 1 BOTTLE | TABLET | 90 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 16571-173 | EPLERENONE TABLET [RISING PHARMA HOLDINGS, INC.] | 1 | Current NDC, 2 package rows | 20241001_9b66a393-8af1-42bc-9673-89fe471147ee.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 16571-173-03 | 16571017303 | 30 TABLET in 1 BOTTLE (16571-173-03) | 30 tablet | 2024-09-30 | No | No | Current |
| 16571-173-09 | 16571017309 | 90 TABLET in 1 BOTTLE (16571-173-09) | 90 tablet | 2024-09-30 | No | No | Current |