Eplerenone
- Product NDC
- 71335-2355
- 11-digit product format
- 713352355
- Labeler code
- 71335
- Product ID
- 71335-2355_3b033db4-feaa-4c28-876e-8042b0f2cf60
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Eplerenone
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA207842
- Marketing category
- ANDA
- Marketing start
- 2021-11-08
- 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 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71335-2355-1 | Eplerenone | 90 in 1 BOTTLE, PLASTIC | TABLET, COATED | 90 | | 1 |
| 71335-2355-2 | Eplerenone | 30 in 1 BOTTLE, PLASTIC | TABLET, COATED | 30 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71335-2355 | EPLERENONE TABLET, COATED [BRYANT RANCH PREPACK] | 1 | Current NDC, 2 package rows | 20240529_2002cf90-2d4a-43b1-bcd6-c447cbc7010f.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 71335-2355-1 | 71335235501 | 90 TABLET, COATED in 1 BOTTLE, PLASTIC (71335-2355-1) | 2024-05-28 | No | No | Current |
| 71335-2355-2 | 71335235502 | 30 TABLET, COATED in 1 BOTTLE, PLASTIC (71335-2355-2) | 2024-05-28 | No | No | Current |