Manufacturing Establishments3
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Bayer AG
Bayer Healthcare Pharmaceuticals Inc.
314398484
Sharp Corporation
Bayer Healthcare Pharmaceuticals Inc.
143696495
AMPAC Fine Chemicals, Rancho Cordova
Bayer Healthcare Pharmaceuticals Inc.
073903937
Products2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Kerendia
Product Details
NDC Product Code
50419-541Application Number
NDA215341Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
July 9, 2021LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
FinerenoneActive
Code: DE2O63YV8RClass: ACTIBQuantity: 20 mg in 1 1
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
Kerendia
Product Details
NDC Product Code
50419-540Application Number
NDA215341Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
July 9, 2021LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
FinerenoneActive
Code: DE2O63YV8RClass: ACTIBQuantity: 10 mg in 1 1