NDC 0378-4276

Valacyclovir Hydrochloride

Valacyclovir

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

Product ID0378-4276_2df85452-4175-4401-91db-4a8531c8b288
NDC0378-4276
Product TypeHuman Prescription Drug
Proprietary NameValacyclovir Hydrochloride
Generic NameValacyclovir
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2010-05-24
Marketing CategoryANDA / ANDA
Application NumberANDA078518
Labeler NameMylan Pharmaceuticals Inc.
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 Through2022-12-31

Packaging

NDC 0378-4276-77

90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-4276-77)
Marketing Start Date2010-05-24
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0378-4276-93 [00378427693]

Valacyclovir Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078518
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-05-24

NDC 0378-4276-77 [00378427677]

Valacyclovir Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078518
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-05-24

NDC 0378-4276-05 [00378427605]

Valacyclovir Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078518
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-05-24
Marketing End Date2018-06-30

Drug Details

Active Ingredients

IngredientStrength
VALACYCLOVIR HYDROCHLORIDE1 g/1

OpenFDA Data

SPL SET ID:56bf715d-8280-4557-9f98-9693932199e5
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 313564
  • 313565
    • UPC Code
  • 0303784275931
  • 0303784276938

    • 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"

    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
    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
    16714-698Valacyclovir 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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