Eplerenone

Product NDC
71335-2355
11-digit product format
713352355
Labeler code
71335
Product ID
71335-2355_3b033db4-feaa-4c28-876e-8042b0f2cf60
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Eplerenone
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA207842
Marketing category
ANDA
Marketing start
2021-11-08
Substance
EPLERENONE
Active strength
25 mg/1
Pharmacologic classes
Aldosterone Antagonist [EPC], Aldosterone Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
6995V82D0BEPLERENONE107724-20-9EPLERENONE

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71335-2355-17133523550190 TABLET, COATED in 1 BOTTLE, PLASTIC (71335-2355-1) 2024-05-28NoNoHistorical
71335-2355-27133523550230 TABLET, COATED in 1 BOTTLE, PLASTIC (71335-2355-2) 2024-05-28NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
EplerenoneBryant Ranch Prepack2024-05-28HUMAN PRESCRIPTION DRUG LABEL1