NDC 55648-153

VALACYCLOVIR HYDROCHLORIDE

Valacyclovir Hydrochloride

VALACYCLOVIR HYDROCHLORIDE is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Wockhardt Limited. The primary component is Valacyclovir Hydrochloride.

Product ID55648-153_88df95c2-5088-4980-9d78-2d1760033ba7
NDC55648-153
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 NumberANDA090216
Labeler NameWockhardt Limited
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 55648-153-01

21 TABLET, FILM COATED in 1 BOTTLE (55648-153-01)
Marketing Start Date2010-05-24
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 55648-153-03 [55648015303]

VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090216
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-05-24
Inactivation Date2020-01-31

NDC 55648-153-05 [55648015305]

VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090216
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-05-24
Inactivation Date2020-01-31

NDC 55648-153-06 [55648015306]

VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090216
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-04-03
Inactivation Date2020-01-31

NDC 55648-153-02 [55648015302]

VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090216
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-05-24
Inactivation Date2020-01-31

NDC 55648-153-01 [55648015301]

VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090216
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-05-24
Inactivation Date2020-01-31

NDC 55648-153-04 [55648015304]

VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090216
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-05-24
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
VALACYCLOVIR HYDROCHLORIDE1 g/1

OpenFDA Data

SPL SET ID:a9e1d18e-ad45-4183-bd98-53c7e0b36556
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 313564
  • 313565
  • UPC Code
  • 0364679153062
  • 0364679152010
  • 0364679153048
  • 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.