NDC 68382-225

Valacyclovir

Valacyclovir

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

Product ID68382-225_1dbc09c9-e29c-4c0c-8897-4fe89eeffef1
NDC68382-225
Product TypeHuman Prescription Drug
Proprietary NameValacyclovir
Generic NameValacyclovir
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2018-04-05
Marketing CategoryANDA / ANDA
Application NumberANDA079137
Labeler NameZydus Pharmaceuticals (USA) 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 68382-225-01

100 TABLET, FILM COATED in 1 BOTTLE (68382-225-01)
Marketing Start Date2018-04-05
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68382-225-01 [68382022501]

Valacyclovir TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA079137
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-04-05

NDC 68382-225-10 [68382022510]

Valacyclovir TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA079137
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-04-05

NDC 68382-225-77 [68382022577]

Valacyclovir TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA079137
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-04-05

NDC 68382-225-06 [68382022506]

Valacyclovir TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA079137
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-04-05

NDC 68382-225-30 [68382022530]

Valacyclovir TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA079137
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-04-05
Marketing End Date2019-12-05

Drug Details

Active Ingredients

IngredientStrength
VALACYCLOVIR HYDROCHLORIDE500 mg/1

OpenFDA Data

SPL SET ID:272c1aab-426f-4d7d-a3ea-235fdcb6003a
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 313564
  • 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" or generic name "Valacyclovir"

    NDCBrand NameGeneric Name
    0093-7258ValacyclovirValacyclovir
    0093-7259ValacyclovirValacyclovir
    31722-704ValacyclovirValacyclovir
    31722-705ValacyclovirValacyclovir
    43063-771ValacyclovirValacyclovir
    43353-883ValacyclovirValacyclovir Hydrochloride
    50090-2510ValacyclovirValacyclovir
    50090-2575ValacyclovirValacyclovir
    50436-0704ValacyclovirValacyclovir
    50436-7050ValacyclovirValacyclovir
    51407-107ValacyclovirValacyclovir
    51407-108ValacyclovirValacyclovir
    51660-904VALACYCLOVIRVALACYCLOVIR HYDROCHLORIDE
    51660-905VALACYCLOVIRVALACYCLOVIR HYDROCHLORIDE
    52343-051Valacyclovirvalacyclovir hydrochloride
    52343-052Valacyclovirvalacyclovir hydrochloride
    55700-913ValacyclovirValacyclovir
    60760-469ValacyclovirValacyclovir
    61919-066ValacyclovirValacyclovir
    61919-515VALACYCLOVIRVALACYCLOVIR
    61919-919ValacyclovirValacyclovir
    68071-3135ValacyclovirValacyclovir
    68071-3276ValacyclovirValacyclovir
    68071-3372ValacyclovirValacyclovir
    68071-4805ValacyclovirValacyclovir
    68382-226ValacyclovirValacyclovir
    68382-225ValacyclovirValacyclovir
    70518-0323ValacyclovirValacyclovir
    70934-106ValacyclovirValacyclovir
    71335-0630ValacyclovirValacyclovir
    63187-950ValacyclovirValacyclovir
    63304-904ValacyclovirValacyclovir
    63304-905ValacyclovirValacyclovir
    65841-630ValacyclovirValacyclovir
    65841-629ValacyclovirValacyclovir
    63629-7958ValacyclovirValacyclovir
    70518-2402ValacyclovirValacyclovir
    68071-3332ValacyclovirValacyclovir
    0378-4275Valacyclovir Hydrochloridevalacyclovir
    0378-4276Valacyclovir Hydrochloridevalacyclovir

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