NDC 63187-776

Valacyclovir Hydrochloride

Valacyclovir Hydrochloride

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

Product ID63187-776_2a38883b-987e-4364-9705-27dcbe7cdd50
NDC63187-776
Product TypeHuman Prescription Drug
Proprietary NameValacyclovir Hydrochloride
Generic NameValacyclovir Hydrochloride
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2010-05-24
Marketing CategoryANDA / ANDA
Application NumberANDA090682
Labeler NameProficient Rx LP
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 Through2020-12-31

Packaging

NDC 63187-776-04

4 TABLET, FILM COATED in 1 BOTTLE (63187-776-04)
Marketing Start Date2016-12-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63187-776-10 [63187077610]

Valacyclovir Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090682
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-11-21

NDC 63187-776-90 [63187077690]

Valacyclovir Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090682
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-11-01

NDC 63187-776-14 [63187077614]

Valacyclovir Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090682
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-11-21

NDC 63187-776-30 [63187077630]

Valacyclovir Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090682
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-11-01

NDC 63187-776-20 [63187077620]

Valacyclovir Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090682
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2020-02-05

NDC 63187-776-21 [63187077621]

Valacyclovir Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090682
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-11-01

NDC 63187-776-04 [63187077604]

Valacyclovir Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090682
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-12-01

NDC 63187-776-60 [63187077660]

Valacyclovir Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090682
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-11-01

Drug Details

Active Ingredients

IngredientStrength
VALACYCLOVIR HYDROCHLORIDE1 g/1

OpenFDA Data

SPL SET ID:268af320-810a-48de-9a08-9850be2878e3
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 313564

    • 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 Hydrochloride" or generic name "Valacyclovir Hydrochloride"

    NDCBrand NameGeneric Name
    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
    16714-698Valacyclovir HydrochlorideValacyclovir Hydrochloride
    68071-1842Valacyclovir hydrochlorideValacyclovir hydrochloride
    68071-1548Valacyclovir HydrochlorideValacyclovir Hydrochloride
    68071-2099Valacyclovir hydrochlorideValacyclovir hydrochloride
    68071-2110Valacyclovir hydrochlorideValacyclovir hydrochloride
    68071-3360Valacyclovir HydrochlorideValacyclovir Hydrochloride
    68071-3037Valacyclovir hydrochlorideValacyclovir hydrochloride
    68071-4040Valacyclovir hydrochlorideValacyclovir hydrochloride
    68071-3381Valacyclovir HydrochlorideValacyclovir Hydrochloride
    68071-4474Valacyclovir HydrochlorideValacyclovir Hydrochloride
    68071-4727Valacyclovir HydrochlorideValacyclovir Hydrochloride
    68071-4783Valacyclovir HydrochlorideValacyclovir Hydrochloride
    68071-4407Valacyclovir HydrochlorideValacyclovir Hydrochloride
    68071-4728Valacyclovir HydrochlorideValacyclovir Hydrochloride
    68084-215Valacyclovir HydrochlorideValacyclovir Hydrochloride
    68084-309Valacyclovir HydrochlorideValacyclovir Hydrochloride
    68788-6379valacyclovir hydrochloridevalacyclovir hydrochloride
    68788-6896Valacyclovir hydrochlorideValacyclovir hydrochloride
    68788-6345Valacyclovir hydrochlorideValacyclovir hydrochloride
    68788-9984valacyclovir hydrochloridevalacyclovir hydrochloride
    68788-9432Valacyclovir HydrochlorideValacyclovir Hydrochloride
    68788-9554VALACYCLOVIR HYDROCHLORIDEVALACYCLOVIR HYDROCHLORIDE
    69097-154Valacyclovir hydrochlorideValacyclovir hydrochloride
    69097-153Valacyclovir hydrochlorideValacyclovir hydrochloride
    70518-0541Valacyclovir HydrochlorideValacyclovir Hydrochloride
    70518-1302Valacyclovir HydrochlorideValacyclovir Hydrochloride
    70518-1106Valacyclovir hydrochlorideValacyclovir hydrochloride
    70518-1934Valacyclovir HydrochlorideValacyclovir Hydrochloride
    70518-1990Valacyclovir hydrochlorideValacyclovir hydrochloride
    70934-180Valacyclovir hydrochlorideValacyclovir hydrochloride
    71335-0021Valacyclovir hydrochlorideValacyclovir hydrochloride
    71335-0123Valacyclovir hydrochlorideValacyclovir hydrochloride
    71335-0708Valacyclovir HydrochlorideValacyclovir Hydrochloride
    75921-208VALACYCLOVIR HYDROCHLORIDEVALACYCLOVIR HYDROCHLORIDE
    21695-832Valacyclovir HydrochlorideValacyclovir Hydrochloride
    21695-965Valacyclovir HydrochlorideValacyclovir Hydrochloride
    43063-778Valacyclovir hydrochlorideValacyclovir hydrochloride
    43063-534Valacyclovir hydrochlorideValacyclovir hydrochloride
    43063-730Valacyclovir HydrochlorideValacyclovir Hydrochloride
    43063-200Valacyclovir HydrochlorideValacyclovir Hydrochloride
    45963-559Valacyclovir hydrochlorideValacyclovir hydrochloride
    45963-558Valacyclovir hydrochlorideValacyclovir hydrochloride
    50090-2101Valacyclovir hydrochlorideValacyclovir hydrochloride
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