NDC 68071-4040

Valacyclovir hydrochloride

Valacyclovir Hydrochloride

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

Product ID68071-4040_615543ed-0bac-0570-e053-2991aa0aa137
NDC68071-4040
Product TypeHuman Prescription Drug
Proprietary NameValacyclovir hydrochloride
Generic NameValacyclovir Hydrochloride
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2011-04-25
Marketing CategoryANDA / ANDA
Application NumberANDA090370
Labeler NameNuCare Pharmaceuticals,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 Through2019-12-31

Packaging

NDC 68071-4040-8

8 TABLET, FILM COATED in 1 BOTTLE (68071-4040-8)
Marketing Start Date2017-12-27
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68071-4040-1 [68071404001]

Valacyclovir hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090370
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-12-27
Marketing End Date2019-12-31
Inactivation Date2020-01-31
Reactivation Date2020-05-22

NDC 68071-4040-3 [68071404003]

Valacyclovir hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090370
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-12-27
Marketing End Date2019-12-31
Inactivation Date2020-01-31
Reactivation Date2020-05-22

NDC 68071-4040-2 [68071404002]

Valacyclovir hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090370
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-12-27
Marketing End Date2019-12-31
Inactivation Date2020-01-31
Reactivation Date2020-05-22

NDC 68071-4040-8 [68071404008]

Valacyclovir hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090370
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-12-27
Marketing End Date2019-12-31
Inactivation Date2020-01-31
Reactivation Date2020-05-22

Drug Details

Active Ingredients

IngredientStrength
VALACYCLOVIR HYDROCHLORIDE500 mg/1

OpenFDA Data

SPL SET ID:61553ff0-ec55-0464-e053-2991aa0a9552
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 313565
  • 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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