NDC 63304-904

Valacyclovir

Valacyclovir

Valacyclovir is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Sun Pharmaceutical Industries, Inc.. The primary component is Valacyclovir Hydrochloride.

Product ID63304-904_38096845-f38d-4b13-a3af-e997d8bf3716
NDC63304-904
Product TypeHuman Prescription Drug
Proprietary NameValacyclovir
Generic NameValacyclovir
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2020-12-19
Marketing CategoryANDA / ANDA
Application NumberANDA076588
Labeler NameSUN PHARMACEUTICAL INDUSTRIES, INC.
Substance NameVALACYCLOVIR HYDROCHLORIDE
Active Ingredient Strength500 mg/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 Through2021-12-31

Packaging

NDC 63304-904-03

10 TABLET, FILM COATED in 1 BOTTLE (63304-904-03)
Marketing Start Date2020-12-19
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63304-904-90 [63304090490]

Valacyclovir TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA076588
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-07-19
Inactivation Date2020-01-31

NDC 63304-904-03 [63304090403]

Valacyclovir TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA076588
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2007-01-31
Inactivation Date2020-01-31

NDC 63304-904-05 [63304090405]

Valacyclovir TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA076588
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2007-01-31
Inactivation Date2020-01-31

NDC 63304-904-30 [63304090430]

Valacyclovir TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA076588
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2007-01-31
Inactivation Date2020-01-31

NDC 63304-904-11 [63304090411]

Valacyclovir TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA076588
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-07-19

NDC 63304-904-77 [63304090477]

Valacyclovir TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA076588
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-07-19
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
VALACYCLOVIR HYDROCHLORIDE500 mg/1

OpenFDA Data

SPL SET ID:26634bf1-c6d8-4d48-9a4e-845c47df07f8
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 313564
  • 313565
    • UPC Code
  • 0363304904307

    • 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]

    Medicade Reported Pricing

    63304090430 VALACYCLOVIR HCL 500 MG TABLET

    Pricing Unit: EA | Drug Type:

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

    NDCBrand NameGeneric Name
    0093-7258ValacyclovirValacyclovir
    0093-7259ValacyclovirValacyclovir
    31722-704ValacyclovirValacyclovir
    31722-705ValacyclovirValacyclovir
    43063-771ValacyclovirValacyclovir
    43353-883ValacyclovirValacyclovir Hydrochloride
    50090-2510ValacyclovirValacyclovir
    50090-2575ValacyclovirValacyclovir
    50436-0704ValacyclovirValacyclovir
    50436-7050ValacyclovirValacyclovir
    51407-107ValacyclovirValacyclovir
    51407-108ValacyclovirValacyclovir
    51660-904VALACYCLOVIRVALACYCLOVIR HYDROCHLORIDE
    51660-905VALACYCLOVIRVALACYCLOVIR HYDROCHLORIDE
    52343-051Valacyclovirvalacyclovir hydrochloride
    52343-052Valacyclovirvalacyclovir hydrochloride
    55700-913ValacyclovirValacyclovir
    60760-469ValacyclovirValacyclovir
    61919-066ValacyclovirValacyclovir
    61919-515VALACYCLOVIRVALACYCLOVIR
    61919-919ValacyclovirValacyclovir
    68071-3135ValacyclovirValacyclovir
    68071-3276ValacyclovirValacyclovir
    68071-3372ValacyclovirValacyclovir
    68071-4805ValacyclovirValacyclovir
    68382-226ValacyclovirValacyclovir
    68382-225ValacyclovirValacyclovir
    70518-0323ValacyclovirValacyclovir
    70934-106ValacyclovirValacyclovir
    71335-0630ValacyclovirValacyclovir
    63187-950ValacyclovirValacyclovir
    63304-904ValacyclovirValacyclovir
    63304-905ValacyclovirValacyclovir
    65841-630ValacyclovirValacyclovir
    65841-629ValacyclovirValacyclovir
    63629-7958ValacyclovirValacyclovir
    70518-2402ValacyclovirValacyclovir
    68071-3332ValacyclovirValacyclovir
    0378-4275Valacyclovir Hydrochloridevalacyclovir
    0378-4276Valacyclovir Hydrochloridevalacyclovir
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