MedPath
FDA Product

Valacyclovir Hydrochloride

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Valacyclovir Hydrochloride

63739-525

Regulatory Information

63739-525

ANDA090682

C73584

January 3, 2024

USA

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

HUMAN PRESCRIPTION DRUG LABEL

10

Company Information

140529962

Active Ingredients

CROSPOVIDONE (15 MPA.S AT 5%)

Code: 68401960MK

Class Code: IACT

FD&C BLUE NO. 2

Code: L06K8R7DQK

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

MICROCRYSTALLINE CELLULOSE

Code: OP1R32D61U

Class Code: IACT

POLYETHYLENE GLYCOL 400

Code: B697894SGQ

Class Code: IACT

HYPROMELLOSE 2910 (6 MPA.S)

Code: 0WZ8WG20P6

Class Code: IACT

POLYSORBATE 80

Code: 6OZP39ZG8H

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

VALACYCLOVIR HYDROCHLORIDE

Quantity: 500 mg in 1 1

Code: G447S0T1VC

Class Code: ACTIR

POVIDONE K90

Code: RDH86HJV5Z

Class Code: IACT

Active Moieties

ACYCLOVIR

Code: X4HES1O11F

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