NDC 55700-345

valacyclovir hydrochloride

Valacyclovir Hydrochloride

valacyclovir hydrochloride is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Lake Erie Medical Dba Quality Care Products Llc. The primary component is Valacyclovir Hydrochloride.

Product ID55700-345_df89b94e-92a5-478d-a7f2-4ff36f3def69
NDC55700-345
Product TypeHuman Prescription Drug
Proprietary Namevalacyclovir hydrochloride
Generic NameValacyclovir Hydrochloride
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2012-04-05
Marketing CategoryANDA / ANDA
Application NumberANDA201506
Labeler NameLake Erie Medical DBA Quality Care Products 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 55700-345-21

21 TABLET, FILM COATED in 1 BOTTLE (55700-345-21)
Marketing Start Date2015-12-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 55700-345-30 [55700034530]

valacyclovir hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA201506
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-12-15

NDC 55700-345-21 [55700034521]

valacyclovir hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA201506
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-12-15

Drug Details

Active Ingredients

IngredientStrength
VALACYCLOVIR HYDROCHLORIDE1 g/1

OpenFDA Data

SPL SET ID:56c4d937-f615-434f-9793-c8991c498ad4
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

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.