Valganciclovir
HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use VALGANCICLOVIR TABLETS safely and effectively. See full prescribing information for VALGANCICLOVIR TABLETS. VALGANCICLOVIR tablets, for oral use Initial U.S. Approval: 2001
Approved
Approval ID
d9b7ccf8-aec2-9f48-e053-2a95a90a5d04
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 8, 2023
Manufacturers
FDA
McKesson Corporation DBA SKY Packaging
DUNS: 140529962
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Valganciclovir
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63739-076
Application NumberANDA205166
Product Classification
M
Marketing Category
C73584
G
Generic Name
Valganciclovir
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 8, 2023
FDA Product Classification
INGREDIENTS (10)
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
VALGANCICLOVIR HYDROCHLORIDEActive
Quantity: 450 mg in 1 1
Code: 4P3T9QF9NZ
Classification: ACTIR
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT