MedPath

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

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