Basic Information
Eplerenone
42291-454
Regulatory Information
42291-454
ANDA207842
C73584
January 9, 2024
USA
Eplerenone Tablet Rx Only These highlights do not include all the information needed to use EPLERENONE TABLETS safely and effectively. See full prescribing information for EPLERENONE TABLETS. Initial U.S. Approval: 2002
HUMAN PRESCRIPTION DRUG LABEL
3
Company Information
796560394
Active Ingredients
MICROCRYSTALLINE CELLULOSE
Code: OP1R32D61U
Class Code: IACT
MAGNESIUM STEARATE
Code: 70097M6I30
Class Code: IACT
CROSCARMELLOSE SODIUM
Code: M28OL1HH48
Class Code: IACT
TALC
Code: 7SEV7J4R1U
Class Code: IACT
POLYETHYLENE GLYCOL, UNSPECIFIED
Code: 3WJQ0SDW1A
Class Code: IACT
LACTOSE MONOHYDRATE
Code: EWQ57Q8I5X
Class Code: IACT
HYPROMELLOSE, UNSPECIFIED
Code: 3NXW29V3WO
Class Code: IACT
SODIUM LAURYL SULFATE
Code: 368GB5141J
Class Code: IACT
TITANIUM DIOXIDE
Code: 15FIX9V2JP
Class Code: IACT
FERRIC OXIDE YELLOW
Code: EX438O2MRT
Class Code: IACT
FD&C BLUE NO. 2--ALUMINUM LAKE
Code: 4AQJ3LG584
Class Code: IACT
Active Moieties
EPLERENONE
Code: 6995V82D0B