Eplerenone
- Product NDC
- 0378-1031
- 11-digit product format
- 003781031
- Labeler code
- 0378
- Product ID
- 0378-1031_cc3016f1-a03a-4d17-a624-48c9685906e7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- eplerenone
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- ANDA203896
- Marketing category
- ANDA
- Marketing start
- 2017-10-03
- Marketing end
- 2022-08-31
- Substance
- EPLERENONE
- Active strength
- 50 mg/1
- Pharmacologic classes
- Aldosterone Antagonist [EPC], Aldosterone Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0378-1031-77 | 00378103177 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-1031-77) | 2017-10-03 | 2022-08-31 | No | No | Current |
| 0378-1031-93 | 00378103193 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-1031-93) | 2017-10-03 | 2022-08-31 | No | No | Current |