Eplerenone
- Product NDC
- 71205-864
- 11-digit product format
- 712050864
- Labeler code
- 71205
- Product ID
- 71205-864_49b9759a-c1b9-4ebe-874b-81fb82a42755
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Eplerenone
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA207842
- Marketing category
- ANDA
- Marketing start
- 2021-11-08
- Substance
- EPLERENONE
- Active strength
- 50 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 | 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 |
|---|
| 71205-864-00 | Eplerenone | 100 in 1 BOTTLE, PLASTIC | TABLET, COATED | 100 | | 1 |
| 71205-864-11 | Eplerenone | 1000 in 1 BOTTLE, PLASTIC | TABLET, COATED | 1000 | | 1 |
| 71205-864-30 | Eplerenone | 30 in 1 BOTTLE, PLASTIC | TABLET, COATED | 30 | | 1 |
| 71205-864-55 | Eplerenone | 500 in 1 BOTTLE, PLASTIC | TABLET, COATED | 500 | | 1 |
| 71205-864-60 | Eplerenone | 60 in 1 BOTTLE, PLASTIC | TABLET, COATED | 60 | | 1 |
| 71205-864-72 | Eplerenone | 120 in 1 BOTTLE, PLASTIC | TABLET, COATED | 120 | | 1 |
| 71205-864-78 | Eplerenone | 180 in 1 BOTTLE, PLASTIC | TABLET, COATED | 180 | | 1 |
| 71205-864-90 | Eplerenone | 90 in 1 BOTTLE, PLASTIC | TABLET, COATED | 90 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71205-864 | EPLERENONE TABLET, COATED [PROFICIENT RX LP] | 1 | Current NDC, Legacy NDC, 8 package rows | 20220329_49b9759a-c1b9-4ebe-874b-81fb82a42755.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 |
|---|
| 71205-864-00 | 71205086400 | 100 TABLET, COATED in 1 BOTTLE, PLASTIC (71205-864-00) | 2022-03-24 | 0000-00-00 | No | No | Current |
| 71205-864-11 | 71205086411 | 1000 TABLET, COATED in 1 BOTTLE, PLASTIC (71205-864-11) | 2022-03-24 | 0000-00-00 | No | No | Current |
| 71205-864-30 | 71205086430 | 30 TABLET, COATED in 1 BOTTLE, PLASTIC (71205-864-30) | 2022-03-24 | 0000-00-00 | No | No | Current |
| 71205-864-55 | 71205086455 | 500 TABLET, COATED in 1 BOTTLE, PLASTIC (71205-864-55) | 2022-03-24 | 0000-00-00 | No | No | Current |
| 71205-864-60 | 71205086460 | 60 TABLET, COATED in 1 BOTTLE, PLASTIC (71205-864-60) | 2022-03-24 | 0000-00-00 | No | No | Current |
| 71205-864-72 | 71205086472 | 120 TABLET, COATED in 1 BOTTLE, PLASTIC (71205-864-72) | 2022-03-24 | 0000-00-00 | No | No | Current |
| 71205-864-78 | 71205086478 | 180 TABLET, COATED in 1 BOTTLE, PLASTIC (71205-864-78) | 2022-03-24 | 0000-00-00 | No | No | Current |
| 71205-864-90 | 71205086490 | 90 TABLET, COATED in 1 BOTTLE, PLASTIC (71205-864-90) | 2022-03-24 | 0000-00-00 | No | No | Current |