FDA.reportPublic FDA data

EPLERENONE

Product NDC
31722-050
11-digit product format
317220050
Labeler code
31722
Product ID
31722-050_fe285cf1-1e78-943b-e053-6394a90a760d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
EPLERENONE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA213812
Marketing category
ANDA
Marketing start
2023-06-02
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
31722-050-30EPLERENONE30 in 1 BOTTLETABLET, FILM COATED301
31722-050-90EPLERENONE90 in 1 BOTTLETABLET, FILM COATED901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-050-30EA - Each31722-05078dc3119-683c-4d35-b039-3cfcbf5125ab12023-10-16
31722-050-90EA - Each31722-0508d91d7b6-2794-49d1-a5cc-985959536b5012023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-050EPLERENONE (EPLERENONE) TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.]1Current NDC, 2 package rows20230616_25a1c77c-7008-4b07-af14-5522a282783a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351256eplerenone 25 MG Oral TabletPSN25a1c77c-7008-4b07-af14-5522a282783a1
351257eplerenone 50 MG Oral TabletPSN25a1c77c-7008-4b07-af14-5522a282783a1
351256eplerenone 25 MG Oral TabletSCD25a1c77c-7008-4b07-af14-5522a282783a1
351257eplerenone 50 MG Oral TabletSCD25a1c77c-7008-4b07-af14-5522a282783a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
31722-050-303172200503030 TABLET, FILM COATED in 1 BOTTLE (31722-050-30) 2023-06-02NoNoCurrent
31722-050-903172200509090 TABLET, FILM COATED in 1 BOTTLE (31722-050-90) 2023-06-02NoNoCurrent