NDC 52343-052

Valacyclovir

Valacyclovir Hydrochloride

Valacyclovir is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Acetris Health, Llc. The primary component is Valacyclovir Hydrochloride.

Product ID52343-052_8a65396c-9ace-4d71-966b-65265bef5ae7
NDC52343-052
Product TypeHuman Prescription Drug
Proprietary NameValacyclovir
Generic NameValacyclovir Hydrochloride
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2010-05-24
Marketing CategoryANDA / ANDA
Application NumberANDA090682
Labeler NameACETRIS HEALTH, LLC
Substance NameVALACYCLOVIR HYDROCHLORIDE
Active Ingredient Strength1 g/1
Pharm ClassesDNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [EXT]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 52343-052-30

30 TABLET, FILM COATED in 1 BOTTLE (52343-052-30)
Marketing Start Date2010-05-24
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 52343-052-30 [52343005230]

Valacyclovir TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090682
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-05-24

NDC 52343-052-90 [52343005290]

Valacyclovir TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090682
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-05-24

Drug Details

Active Ingredients

IngredientStrength
VALACYCLOVIR HYDROCHLORIDE1 g/1

OpenFDA Data

SPL SET ID:1cd5d77f-6478-4176-b703-6bfb3f5cb305
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 313564
  • 313565
    • UPC Code
  • 0352343052902

    • Pharmacological Class

    • DNA Polymerase Inhibitors [MoA]
    • Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC]
    • Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC]
    • Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC]
    • Nucleoside Analog [EXT]

    NDC Crossover Matching brand name "Valacyclovir" or generic name "Valacyclovir Hydrochloride"

    NDCBrand NameGeneric Name
    0093-7258ValacyclovirValacyclovir
    0093-7259ValacyclovirValacyclovir
    68071-3135ValacyclovirValacyclovir
    68071-3276ValacyclovirValacyclovir
    68071-3372ValacyclovirValacyclovir
    68071-4805ValacyclovirValacyclovir
    68382-226ValacyclovirValacyclovir
    68382-225ValacyclovirValacyclovir
    70518-0323ValacyclovirValacyclovir
    70934-106ValacyclovirValacyclovir
    71335-0630ValacyclovirValacyclovir
    31722-704ValacyclovirValacyclovir
    31722-705ValacyclovirValacyclovir
    43063-771ValacyclovirValacyclovir
    43353-883ValacyclovirValacyclovir
    50090-2575ValacyclovirValacyclovir
    50090-2510ValacyclovirValacyclovir
    51660-904VALACYCLOVIRVALACYCLOVIR
    51660-905VALACYCLOVIRVALACYCLOVIR
    52343-051ValacyclovirValacyclovir
    52343-052ValacyclovirValacyclovir
    61919-066ValacyclovirValacyclovir
    61919-919ValacyclovirValacyclovir
    63187-950ValacyclovirValacyclovir
    63304-904ValacyclovirValacyclovir
    63304-905ValacyclovirValacyclovir
    65841-630ValacyclovirValacyclovir
    65841-629ValacyclovirValacyclovir
    61919-515VALACYCLOVIRVALACYCLOVIR
    63629-7958ValacyclovirValacyclovir
    50436-7050ValacyclovirValacyclovir
    50436-0704ValacyclovirValacyclovir
    70518-2402ValacyclovirValacyclovir
    68071-3332ValacyclovirValacyclovir
    0378-4275Valacyclovir Hydrochloridevalacyclovir
    0378-4276Valacyclovir Hydrochloridevalacyclovir
    0781-5208Valacyclovir HydrochlorideValacyclovir Hydrochloride
    0781-5209Valacyclovir HydrochlorideValacyclovir Hydrochloride
    0904-6565Valacyclovir HydrochlorideValacyclovir Hydrochloride
    10544-937valacyclovir hydrochloridevalacyclovir hydrochloride
    16714-697Valacyclovir HydrochlorideValacyclovir Hydrochloride
    0173-0565VALTREXvalacyclovir hydrochloride
    0173-0933VALTREXvalacyclovir hydrochloride
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