Eplerenone
- Product NDC
- 42291-454
- 11-digit product format
- 422910454
- Labeler code
- 42291
- Product ID
- 42291-454_485d3fe4-eadd-a4dc-e063-6294a90ab9f0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Eplerenone
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- AvKARE
- Application
- ANDA207842
- Marketing category
- ANDA
- Marketing start
- 2022-03-03
- Substance
- EPLERENONE
- Active strength
- 25 mg/1
- Pharmacologic classes
- Aldosterone Antagonist [EPC], Aldosterone Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Eplerenone
- Listing expiration
- 2027-12-31
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 |
|---|
| 42291-454-30 | Eplerenone | 30 in 1 BOTTLE | TABLET, COATED | 30 | | 4 |
| 42291-454-90 | Eplerenone | 90 in 1 BOTTLE | TABLET, COATED | 90 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 42291-454 | EPLERENONE TABLET, COATED [AVKARE] | 3 | Current NDC, Legacy NDC, 2 package rows | 20240110_d953457e-0aff-6c38-e053-2995a90a7d32.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 42291-454-30 | 42291045430 | 30 TABLET, COATED in 1 BOTTLE (42291-454-30) | 2022-08-02 | 0000-00-00 | No | No | Current |
| 42291-454-90 | 42291045490 | 90 TABLET, COATED in 1 BOTTLE (42291-454-90) | 2022-03-03 | 0000-00-00 | No | No | Current |