Eplerenone
- Product NDC
- 69367-307
- 11-digit product format
- 693670307
- Labeler code
- 69367
- Product ID
- 69367-307_905d6ee4-8099-4afa-8535-a9511d468ccc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Eplerenone
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- Westminster Pharmaceuticals, LLC
- Application
- ANDA207842
- Marketing category
- ANDA
- Marketing start
- 2021-11-08
- 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, 351257 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 69367-307-09 | Eplerenone | 90 in 1 BOTTLE, PLASTIC | TABLET, COATED | 90 | | 1 |
| 69367-307-30 | Eplerenone | 30 in 1 BOTTLE, PLASTIC | TABLET, COATED | 30 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69367-307 | EPLERENONE TABLET, COATED [WESTMINSTER PHARMACEUTICALS, LLC] | 1 | Current NDC, Legacy NDC, 2 package rows | 20211117_316d3a98-4cd1-4499-a34c-cac87e016944.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 |
|---|
| 69367-307-09 | 69367030709 | 90 TABLET, COATED in 1 BOTTLE, PLASTIC (69367-307-09) | 2021-11-08 | 0000-00-00 | No | No | Current |
| 69367-307-30 | 69367030730 | 30 TABLET, COATED in 1 BOTTLE, PLASTIC (69367-307-30) | 2021-11-08 | 0000-00-00 | No | No | Current |