VALACYCLOVIR HYDROCHLORIDE
These highlights do not include all the information needed to use valacyclovir hydrochloride safely and effectively. See full prescribing information for valacyclovir hydrochloride. Valacyclovir hydrochloride tablets Rx only Initial U.S. Approval: 1995
Approved
Approval ID
a9e1d18e-ad45-4183-bd98-53c7e0b36556
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 3, 2013
Manufacturers
FDA
Wockhardt Limited
DUNS: 650069115
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
VALACYCLOVIR HYDROCHLORIDE
PRODUCT DETAILS
NDC Product Code55648-153
Application NumberANDA090216
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateApril 3, 2013
Generic NameVALACYCLOVIR HYDROCHLORIDE
INGREDIENTS (11)
VALACYCLOVIR HYDROCHLORIDEActive
Quantity: 1 g in 1 1
Code: G447S0T1VC
Classification: ACTIR
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POVIDONE K90Inactive
Code: RDH86HJV5Z
Classification: IACT