ERIVEDGE
These highlights do not include all the information needed to use ERIVEDGE safely and effectively. See full prescribing information for ERIVEDGE. ERIVEDGE (vismodegib) capsules, for oral useInitial U.S. Approval: 2012
Approved
Approval ID
eb368bb6-80e3-4df9-8a85-91df0a2ada6a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 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.
vismodegib
PRODUCT DETAILS
NDC Product Code50242-140
Application NumberNDA203388
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateMarch 27, 2023
Generic Namevismodegib
INGREDIENTS (12)
VISMODEGIBActive
Quantity: 150 mg in 1 1
Code: 25X868M3DS
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT