Kerendia
These highlights do not include all the information needed to use KERENDIA safely and effectively. See full prescribing information for KERENDIA.Initial U.S. Approval: 2021
Approved
Approval ID
fc726765-5d5a-4d6e-b037-b847bda9fb7c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 1, 2022
Manufacturers
FDA
Bayer Healthcare Pharmaceuticals Inc.
DUNS: 005436809
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
finerenone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50419-541
Application NumberNDA215341
Product Classification
M
Marketing Category
C73594
G
Generic Name
finerenone
Product Specifications
Route of AdministrationORAL
Effective DateJuly 9, 2021
FDA Product Classification
INGREDIENTS (7)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FINERENONEActive
Quantity: 20 mg in 1 1
Code: DE2O63YV8R
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
finerenone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50419-540
Application NumberNDA215341
Product Classification
M
Marketing Category
C73594
G
Generic Name
finerenone
Product Specifications
Route of AdministrationORAL
Effective DateJuly 9, 2021
FDA Product Classification
INGREDIENTS (7)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
FINERENONEActive
Quantity: 10 mg in 1 1
Code: DE2O63YV8R
Classification: ACTIB