EPLERENONE
- Product NDC
- 60687-451
- 11-digit product format
- 606870451
- Labeler code
- 60687
- Product ID
- 60687-451_357fb20b-fdb4-58f9-e063-6394a90ae2a7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- EPLERENONE
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- American Health Packaging
- Application
- ANDA208283
- Marketing category
- ANDA
- Marketing start
- 2019-06-13
- 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 |
|---|
| 60687-451-11 | EPLERENONE | 1 in 1 BLISTER PACK | TABLET, FILM COATED | 1 | | 5 |
| 60687-451-21 | EPLERENONE | 30 in 1 BOX, UNIT-DOSE | TABLET, FILM COATED | 30 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 60687-451 | EPLERENONE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 5 | Current NDC, Legacy NDC, 2 package rows | 20250521_3a3047f2-0155-4a07-955f-839a312cf879.zip |
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 |
|---|
| 60687-451-11 | 60687045111 | 1 in 1 BLISTER PACK | | | | | | Historical |
| 60687-451-21 | 60687045121 | 30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-451-21) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-451-11) | 30 blister pack | 2019-06-13 | 0000-00-00 | No | No | Current |