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
883f643b-27f6-5a3e-e053-2995a90a8ff1
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 17, 2021
Manufacturers
FDA
NuCare Pharmaceuticals,Inc.
DUNS: 010632300
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68071-4885
Application NumberANDA090682
Product Classification
M
Marketing Category
C73584
G
Generic Name
Valacyclovir Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 17, 2021
FDA Product Classification
INGREDIENTS (10)
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
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
POVIDONE K90Inactive
Code: RDH86HJV5Z
Classification: IACT
VALACYCLOVIR HYDROCHLORIDEActive
Quantity: 500 mg in 1 1
Code: G447S0T1VC
Classification: ACTIR