valacyclovir hydrochloride
These highlights do not include all the information needed to use VALACYCLOVIR TABLETS safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS. VALACYCLOVIR tablets, for oral use Initial U.S. Approval: 1995
Approved
Approval ID
3277c17e-f953-2b0a-fe0a-4f5d1aeace9d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 30, 2023
Manufacturers
FDA
Jubilant Cadista Pharmaceuticals Inc.
DUNS: 022490515
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
valacyclovir hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59746-324
Application NumberANDA201506
Product Classification
M
Marketing Category
C73584
G
Generic Name
valacyclovir hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateAugust 30, 2023
FDA Product Classification
INGREDIENTS (9)
Valacyclovir HydrochlorideActive
Quantity: 500 mg in 1 1
Code: G447S0T1VC
Classification: ACTIR
Crospovidone, UnspecifiedInactive
Code: 2S7830E561
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
HypromellosesInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
Polyethylene Glycol 400Inactive
Code: B697894SGQ
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
valacyclovir hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59746-325
Application NumberANDA201506
Product Classification
M
Marketing Category
C73584
G
Generic Name
valacyclovir hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateAugust 30, 2023
FDA Product Classification
INGREDIENTS (9)
Crospovidone, UnspecifiedInactive
Code: 2S7830E561
Classification: IACT
VALACYCLOVIR HYDROCHLORIDEActive
Quantity: 1 g in 1 1
Code: G447S0T1VC
Classification: ACTIR
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
HypromellosesInactive
Code: 3NXW29V3WO
Classification: IACT
Polyethylene Glycol 400Inactive
Code: B697894SGQ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT