ZELBORAF
These highlights do not include all the information needed to use ZELBORAF safely and effectively. See full prescribing information for ZELBORAF. ZELBORAF (vemurafenib) tablet for oral use Initial U.S. Approval: 2011
Approved
Approval ID
38eea320-7e0c-485a-bc30-98c3c45e2763
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 27, 2023
Manufacturers
FDA
Genentech, Inc.
DUNS: 080129000
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Vemurafenib
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50242-090
Application NumberNDA202429
Product Classification
M
Marketing Category
C73594
G
Generic Name
Vemurafenib
Product Specifications
Route of AdministrationORAL
Effective DateNovember 27, 2023
FDA Product Classification
INGREDIENTS (9)
VEMURAFENIBActive
Quantity: 240 mg in 1 1
Code: 207SMY3FQT
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYDROXYPROPYL CELLULOSE (90000 WAMW)Inactive
Code: UKE75GEA7F
Classification: IACT
HYPROMELLOSE ACETATE SUCCINATE 16070722 (3 MPA.S)Inactive
Code: 24P2YXD2PW
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5P
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT