Valacyclovir hydrochloride
These highlights do not include all the information needed to use VALACYCLOVIR TABLETS, USP safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS, USP. VALACYCLOVIR TABLETS, USPInitial U.S. Approval: 1995
Approved
Approval ID
3331ed10-1d2b-4c88-ad2d-881f7f476198
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 7, 2019
Manufacturers
FDA
Unit Dose Services
DUNS: 831995316
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 Code50436-0154
Application NumberANDA077135
Product Classification
M
Marketing Category
C73584
G
Generic Name
Valacyclovir hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 12, 2018
FDA Product Classification
INGREDIENTS (10)
VALACYCLOVIR HYDROCHLORIDEActive
Quantity: 1000 mg in 1 1
Code: G447S0T1VC
Classification: ACTIR
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
HYDROGENATED CASTOR OILInactive
Code: ZF94AP8MEY
Classification: IACT
HYPROMELLOSE 2910 (3 MPA.S)Inactive
Code: 0VUT3PMY82
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
Valacyclovir hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50436-0153
Application NumberANDA077135
Product Classification
M
Marketing Category
C73584
G
Generic Name
Valacyclovir hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 12, 2018
FDA Product Classification
INGREDIENTS (10)
VALACYCLOVIR HYDROCHLORIDEActive
Quantity: 500 mg in 1 1
Code: G447S0T1VC
Classification: ACTIR
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
HYDROGENATED CASTOR OILInactive
Code: ZF94AP8MEY
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
HYPROMELLOSE 2910 (3 MPA.S)Inactive
Code: 0VUT3PMY82
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT