EPLERENONE
- Product NDC
- 51991-878
- 11-digit product format
- 519910878
- Labeler code
- 51991
- Product ID
- 51991-878_546c0ded-8c22-4840-b369-a3029dedc299
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- EPLERENONE
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Breckenridge Pharmaceutical, Inc.
- Application
- ANDA208283
- Marketing category
- ANDA
- Marketing start
- 2018-09-18
- Substance
- EPLERENONE
- Active strength
- 50 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 | 50 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 |
|---|
| 51991-878-11 | EPLERENONE | 10 in 1 CARTON | TABLET, FILM COATED | 10 | | 8 |
| 51991-878-33 | EPLERENONE | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 8 |
| 51991-878-90 | EPLERENONE | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 8 |
| 51991-878-99 | EPLERENONE | 10 in 1 BLISTER PACK | TABLET, FILM COATED | 10 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51991-878 | EPLERENONE TABLET, FILM COATED [BRECKENRIDGE PHARMACEUTICAL, INC.] | 6 | Current NDC, Legacy NDC, 4 package rows | 20240327_e2a51c12-bdc2-4b3b-8e9e-bf363c2817ed.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 |
|---|
| 51991-878-11 | 51991087811 | 10 BLISTER PACK in 1 CARTON (51991-878-11) / 10 TABLET, FILM COATED in 1 BLISTER PACK (51991-878-99) | 10 blister pack | 2018-09-18 | 0000-00-00 | No | No | Current |
| 51991-878-33 | 51991087833 | 30 TABLET, FILM COATED in 1 BOTTLE (51991-878-33) | | 2018-09-18 | 0000-00-00 | No | No | Current |
| 51991-878-90 | 51991087890 | 90 TABLET, FILM COATED in 1 BOTTLE (51991-878-90) | | 2018-09-18 | 0000-00-00 | No | No | Current |
| 51991-878-99 | 51991087899 | 10 in 1 BLISTER PACK | | | | | | Historical |