FDA.reportPublic FDA data

Eplerenone

Product NDC
59762-1720
11-digit product format
597621720
Labeler code
59762
Product ID
59762-1720_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
50 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
IngredientStrength
EPLERENONE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6995V82D0B
Rxcui351256, 351257

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c046e2c-42d6-3179-f149-f207119f6ad5Product name620240530

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59762-1720-1Eplerenone30 in 1 BOTTLETABLET, FILM COATED3025
59762-1720-2Eplerenone90 in 1 BOTTLETABLET, FILM COATED9025

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59762-1720-1EA - Each59762-1720ecf0c846-d6d4-47f3-97fa-6640c075e49312012-07-24
59762-1720-2EA - Each59762-1720cbebc674-b7ff-4eb1-ad36-9d2830401a3812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
EPLERENONEACTIVE INGREDIENT6995V82D0BEPLERENONE TABLET, FILM COATED [GREENSTONE LLC]10
EPLERENONEACTIVE MOIETY6995V82D0BEPLERENONE TABLET, FILM COATED [GREENSTONE LLC]10
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UEPLERENONE TABLET, FILM COATED [GREENSTONE LLC]10
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48EPLERENONE TABLET, FILM COATED [GREENSTONE LLC]10
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675EPLERENONE TABLET, FILM COATED [GREENSTONE LLC]10
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTEPLERENONE TABLET, FILM COATED [GREENSTONE LLC]10
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOEPLERENONE TABLET, FILM COATED [GREENSTONE LLC]10
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GEPLERENONE TABLET, FILM COATED [GREENSTONE LLC]10
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30EPLERENONE TABLET, FILM COATED [GREENSTONE LLC]10
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AEPLERENONE TABLET, FILM COATED [GREENSTONE LLC]10
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HEPLERENONE TABLET, FILM COATED [GREENSTONE LLC]10
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JEPLERENONE TABLET, FILM COATED [GREENSTONE LLC]10
TALCINACTIVE INGREDIENT7SEV7J4R1UEPLERENONE TABLET, FILM COATED [GREENSTONE LLC]10
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPEPLERENONE TABLET, FILM COATED [GREENSTONE LLC]10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59762-1720EPLERENONE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]23Current NDC, Legacy NDC, 2 package rows20250503_6d988699-95c2-46b9-8266-23fe7016f33b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351256eplerenone 25 MG Oral TabletPSN6d988699-95c2-46b9-8266-23fe7016f33b25
351257eplerenone 50 MG Oral TabletPSN6d988699-95c2-46b9-8266-23fe7016f33b25
351256eplerenone 25 MG Oral TabletSCD6d988699-95c2-46b9-8266-23fe7016f33b25
351257eplerenone 50 MG Oral TabletSCD6d988699-95c2-46b9-8266-23fe7016f33b25

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
59762-1720-15976217200130 TABLET, FILM COATED in 1 BOTTLE (59762-1720-1) 2002-09-272026-08-31NoNoCurrent
59762-1720-25976217200290 TABLET, FILM COATED in 1 BOTTLE (59762-1720-2) 2002-09-272026-08-31NoNoCurrent