Eplerenone
- Product NDC
- 59762-1710
- 11-digit product format
- 597621710
- Labeler code
- 59762
- Product ID
- 59762-1710_f63a6d5f-f6ee-4cab-a796-d86aa1b6bf12
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- eplerenone
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- NDA021437
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2002-09-27
- Marketing end
- 2026-08-31
- Substance
- EPLERENONE
- Active strength
- 25 mg/1
- Pharmacologic classes
- Aldosterone Antagonist [EPC], Aldosterone Antagonists [MoA]
- NDC exclude flag
- No
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Eplerenone
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 |
|---|
| 59762-1710-1 | Eplerenone | 100 in 1 CARTON | TABLET, FILM COATED | 100 | | 25 |
| 59762-1710-1 | Eplerenone | 1 in 1 BLISTER PACK | TABLET, FILM COATED | 1 | | 25 |
| 59762-1710-2 | Eplerenone | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 25 |
| 59762-1710-3 | Eplerenone | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 25 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| EPLERENONE | ACTIVE INGREDIENT | 6995V82D0B | EPLERENONE TABLET, FILM COATED [GREENSTONE LLC] | 10 | |
| EPLERENONE | ACTIVE MOIETY | 6995V82D0B | EPLERENONE TABLET, FILM COATED [GREENSTONE LLC] | 10 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | EPLERENONE TABLET, FILM COATED [GREENSTONE LLC] | 10 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | EPLERENONE TABLET, FILM COATED [GREENSTONE LLC] | 10 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | EPLERENONE TABLET, FILM COATED [GREENSTONE LLC] | 10 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | EPLERENONE TABLET, FILM COATED [GREENSTONE LLC] | 10 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | EPLERENONE TABLET, FILM COATED [GREENSTONE LLC] | 10 | |
| LACTOSE | INACTIVE INGREDIENT | J2B2A4N98G | EPLERENONE TABLET, FILM COATED [GREENSTONE LLC] | 10 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | EPLERENONE TABLET, FILM COATED [GREENSTONE LLC] | 10 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | EPLERENONE TABLET, FILM COATED [GREENSTONE LLC] | 10 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | EPLERENONE TABLET, FILM COATED [GREENSTONE LLC] | 10 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | EPLERENONE TABLET, FILM COATED [GREENSTONE LLC] | 10 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | EPLERENONE TABLET, FILM COATED [GREENSTONE LLC] | 10 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | EPLERENONE TABLET, FILM COATED [GREENSTONE LLC] | 10 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 59762-1710 | EPLERENONE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 23 | Current NDC, Legacy NDC, 4 package rows | 20250503_6d988699-95c2-46b9-8266-23fe7016f33b.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 |
|---|
| 59762-1710-1 | 59762171001 | 100 BLISTER PACK in 1 CARTON (59762-1710-1) > 1 TABLET, FILM COATED in 1 BLISTER PACK | 100 blister pack | 2002-09-27 | 0000-00-00 | No | No | Current |
| 59762-1710-2 | 59762171002 | 30 TABLET, FILM COATED in 1 BOTTLE (59762-1710-2) | | 2002-09-27 | 2026-08-31 | No | No | Current |
| 59762-1710-3 | 59762171003 | 90 TABLET, FILM COATED in 1 BOTTLE (59762-1710-3) | | 2002-09-27 | 2026-08-31 | No | No | Current |