ZYKADIA
These highlights do not include all the information needed to use ZYKADIA safely and effectively. See full prescribing information for ZYKADIA. ZYKADIA (ceritinib) capsules, for oral use ZYKADIA (ceritinib) tablets, for oral use Initial U.S. Approval: 2014
Approved
Approval ID
fff5d805-4ffd-4e8e-8e63-6f129697563e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 11, 2024
Manufacturers
FDA
Novartis Pharmaceuticals Corporation
DUNS: 002147023
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
ceritinib
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0078-0694
Application NumberNDA211225
Product Classification
M
Marketing Category
C73594
G
Generic Name
ceritinib
Product Specifications
Route of AdministrationORAL
Effective DateJuly 13, 2021
FDA Product Classification
INGREDIENTS (12)
CERITINIBActive
Quantity: 150 mg in 1 1
Code: K418KG2GET
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT