FDA.reportPublic FDA data

Eplerenone

Product NDC
59762-1108
11-digit product format
597621108
Labeler code
59762
Product ID
59762-1108_b4bf45ee-6524-4a9d-9d7d-91886e32ee72
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
2024-11-14
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
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
59762-1108-1Eplerenone30 in 1 BOTTLETABLET, FILM COATED3046
59762-1108-2Eplerenone90 in 1 BOTTLETABLET, FILM COATED9046

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59762-1108-1EA - Each59762-11089ba1c06e-b769-4ad8-a05c-20878565629412024-12-10
59762-1108-2EA - Each59762-110814062906-24bc-4d4f-a8cd-a4cd96fa12de12025-12-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59762-1108EPLERENONE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]3Current NDC, 2 package rows20250503_4286699b-2320-4d3d-831c-32085f36fb67.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351256eplerenone 25 MG Oral TabletPSN4286699b-2320-4d3d-831c-32085f36fb6746
351257eplerenone 50 MG Oral TabletPSN4286699b-2320-4d3d-831c-32085f36fb6746
351256eplerenone 25 MG Oral TabletSCD4286699b-2320-4d3d-831c-32085f36fb6746
351257eplerenone 50 MG Oral TabletSCD4286699b-2320-4d3d-831c-32085f36fb6746

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
59762-1108-15976211080130 TABLET, FILM COATED in 1 BOTTLE (59762-1108-1) 2024-11-14NoNoHistorical
59762-1108-25976211080290 TABLET, FILM COATED in 1 BOTTLE (59762-1108-2) 2025-11-05NoNoHistorical