Eplerenone
- Product NDC
- 16729-294
- 11-digit product format
- 167290294
- Labeler code
- 16729
- Product ID
- 16729-294_4e68c6b7-2774-172e-e063-6294a90a0e57
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Eplerenone
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Accord Healthcare, Inc.
- Application
- ANDA206922
- Marketing category
- ANDA
- Marketing start
- 2018-10-09
- 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 |
|---|
| 16729-294-10 | Eplerenone | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 9 |
| 16729-294-15 | Eplerenone | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 9 |
| 16729-294-16 | Eplerenone | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 9 |
| 16729-294-17 | Eplerenone | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 9 |
| 16729-294-82 | Eplerenone | 100 in 1 BOX, UNIT-DOSE | TABLET, FILM COATED | 100 | | 9 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 16729-294 | EPLERENONE TABLET, FILM COATED [ACCORD HEALTHCARE, INC.] | 7 | Current NDC, Legacy NDC, 5 package rows | 20240328_b0886e4e-5710-4053-9270-4d7de34068e7.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 |
|---|
| 16729-294-10 | 16729029410 | 30 TABLET, FILM COATED in 1 BOTTLE (16729-294-10) | 2018-10-09 | 0000-00-00 | No | No | Current |
| 16729-294-15 | 16729029415 | 90 TABLET, FILM COATED in 1 BOTTLE (16729-294-15) | 2018-10-09 | 0000-00-00 | No | No | Current |
| 16729-294-16 | 16729029416 | 500 in 1 BOTTLE | | | | | Historical |
| 16729-294-17 | 16729029417 | 1000 in 1 BOTTLE | | | | | Historical |
| 16729-294-82 | 16729029482 | 100 in 1 BOX, UNIT-DOSE | | | | | Historical |