Valganciclovir
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 useInitial U.S. Approval: 2001
Approved
Approval ID
37b7a5d8-9a2c-40b1-a414-71ecc47e567d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 30, 2018
Manufacturers
FDA
Par Pharmaceutical
DUNS: 011103059
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Valganciclovir hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0603-6330
Application NumberANDA200790
Product Classification
M
Marketing Category
C73584
G
Generic Name
Valganciclovir hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateNovember 30, 2018
FDA Product Classification
INGREDIENTS (11)
VALGANCICLOVIR HYDROCHLORIDEActive
Quantity: 450 mg in 1 1
Code: 4P3T9QF9NZ
Classification: ACTIR
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL 4000Inactive
Code: 4R4HFI6D95
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT