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 use Initial U.S. Approval: 2002
Approved
Approval ID
25a1c77c-7008-4b07-af14-5522a282783a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 15, 2023
Manufacturers
FDA
Camber Pharmaceuticals, Inc.
DUNS: 826774775
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 Code31722-050
Application NumberANDA213812
Product Classification
M
Marketing Category
C73584
G
Generic Name
EPLERENONE
Product Specifications
Route of AdministrationORAL
Effective DateJune 15, 2023
FDA Product Classification
INGREDIENTS (15)
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYPROMELLOSE 2910 (3 MPA.S)Inactive
Code: 0VUT3PMY82
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSE 101Inactive
Code: 7T9FYH5QMK
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
MICROCRYSTALLINE CELLULOSE 102Inactive
Code: PNR0YF693Y
Classification: IACT
EPLERENONEActive
Quantity: 50 mg in 1 1
Code: 6995V82D0B
Classification: ACTIB
EPLERENONE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code31722-049
Application NumberANDA213812
Product Classification
M
Marketing Category
C73584
G
Generic Name
EPLERENONE
Product Specifications
Route of AdministrationORAL
Effective DateJune 15, 2023
FDA Product Classification
INGREDIENTS (15)
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYPROMELLOSE 2910 (3 MPA.S)Inactive
Code: 0VUT3PMY82
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MICROCRYSTALLINE CELLULOSE 101Inactive
Code: 7T9FYH5QMK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
MICROCRYSTALLINE CELLULOSE 102Inactive
Code: PNR0YF693Y
Classification: IACT
EPLERENONEActive
Quantity: 25 mg in 1 1
Code: 6995V82D0B
Classification: ACTIB