Eplerenone
These highlights do not include all the information needed to use eplerenone tablets safely and effectively. See full prescribing information for eplerenone tablets. Eplerenone tablets, for oral useInitial U.S. Approval: 2002
Approved
Approval ID
6d988699-95c2-46b9-8266-23fe7016f33b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 27, 2020
Manufacturers
FDA
Greenstone LLC
DUNS: 825560733
FDA
Mylan Pharmaceuticals Inc.
DUNS: 059295980
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
eplerenone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59762-1720
Application NumberNDA021437
Product Classification
M
Marketing Category
C73605
G
Generic Name
eplerenone
Product Specifications
Route of AdministrationORAL
Effective DateAugust 27, 2020
FDA Product Classification
INGREDIENTS (13)
EPLERENONEActive
Quantity: 50 mg in 1 1
Code: 6995V82D0B
Classification: ACTIB
LACTOSE, UNSPECIFIED FORMInactive
Code: J2B2A4N98G
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
eplerenone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59762-1710
Application NumberNDA021437
Product Classification
M
Marketing Category
C73605
G
Generic Name
eplerenone
Product Specifications
Route of AdministrationORAL
Effective DateAugust 27, 2020
FDA Product Classification
INGREDIENTS (13)
LACTOSE, UNSPECIFIED FORMInactive
Code: J2B2A4N98G
Classification: IACT
EPLERENONEActive
Quantity: 25 mg in 1 1
Code: 6995V82D0B
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT