Valacyclovir
VALACYCLOVIR TABLETS
Approved
Approval ID
91832fd8-0d76-4408-9d26-9d5f52c47670
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 5, 2022
Manufacturers
FDA
Zydus Lifesciences Limited
DUNS: 918596198
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Valacyclovir
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code65841-630
Application NumberANDA079137
Product Classification
M
Marketing Category
C73584
G
Generic Name
Valacyclovir
Product Specifications
Route of AdministrationORAL
Effective DateNovember 5, 2022
FDA Product Classification
INGREDIENTS (9)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
VALACYCLOVIR HYDROCHLORIDEActive
Quantity: 1000 mg in 1 1
Code: G447S0T1VC
Classification: ACTIR
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
Valacyclovir
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code65841-629
Application NumberANDA079137
Product Classification
M
Marketing Category
C73584
G
Generic Name
Valacyclovir
Product Specifications
Route of AdministrationORAL
Effective DateNovember 5, 2022
FDA Product Classification
INGREDIENTS (9)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
VALACYCLOVIR HYDROCHLORIDEActive
Quantity: 500 mg in 1 1
Code: G447S0T1VC
Classification: ACTIR
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT