Eplerenone
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
Approved
Approval ID
e8323922-191d-4bfc-8871-fbe15a8a7b58
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 7, 2012
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 1
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 Code54868-6065
Application NumberANDA078510
Product Classification
M
Marketing Category
C73584
G
Generic Name
Eplerenone
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 7, 2012
FDA Product Classification
INGREDIENTS (9)
EPLERENONEActive
Quantity: 25 mg in 1 1
Code: 6995V82D0B
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT