Voriconazole
These highlights do not include all the information needed to use VORICONAZOLE TABLETS safely and effectively. See full prescribing information for VORICONAZOLE TABLETS. VORICONAZOLE tablets, for oral use Initial U.S. Approval: 2002
Approved
Approval ID
3af8cfe6-1c0d-4b57-ae31-05cffa64132e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 23, 2021
Manufacturers
FDA
Mylan Institutional Inc.
DUNS: 039615992
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
voriconazole
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51079-164
Application NumberANDA090547
Product Classification
M
Marketing Category
C73584
G
Generic Name
voriconazole
Product Specifications
Route of AdministrationORAL
Effective DateDecember 23, 2021
FDA Product Classification
INGREDIENTS (9)
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
VORICONAZOLEActive
Quantity: 50 mg in 1 1
Code: JFU09I87TR
Classification: ACTIB
voriconazole
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51079-165
Application NumberANDA090547
Product Classification
M
Marketing Category
C73584
G
Generic Name
voriconazole
Product Specifications
Route of AdministrationORAL
Effective DateDecember 23, 2021
FDA Product Classification
INGREDIENTS (9)
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
VORICONAZOLEActive
Quantity: 200 mg in 1 1
Code: JFU09I87TR
Classification: ACTIB