VALTREX
These highlights do not include all the information needed to use VALTREX safely and effectively. See full prescribing information for VALTREX. VALTREX (valacyclovir) tablets, for oral useInitial U.S. Approval: 1995
Approved
Approval ID
f8e0d8f8-cb73-4206-a484-88f5c4fbd719
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 14, 2022
Manufacturers
FDA
GlaxoSmithKline LLC
DUNS: 167380711
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 Code0173-0933
Application NumberNDA020487
Product Classification
M
Marketing Category
C73594
G
Generic Name
valacyclovir hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJune 30, 2022
FDA Product Classification
INGREDIENTS (12)
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
VALACYCLOVIR HYDROCHLORIDEActive
Quantity: 500 mg in 1 1
Code: G447S0T1VC
Classification: ACTIR
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
CROSPOVIDONE (15 MPA.S AT 5%)Inactive
Code: 68401960MK
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
valacyclovir hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0173-0565
Application NumberNDA020487
Product Classification
M
Marketing Category
C73594
G
Generic Name
valacyclovir hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJune 30, 2022
FDA Product Classification
INGREDIENTS (12)
VALACYCLOVIR HYDROCHLORIDEActive
Quantity: 1 g in 1 1
Code: G447S0T1VC
Classification: ACTIR
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
CROSPOVIDONE (15 MPA.S AT 5%)Inactive
Code: 68401960MK
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT