NDC 43063-771

Valacyclovir

Valacyclovir

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

Product ID43063-771_790ea45f-d422-23fa-e053-2991aa0a8254
NDC43063-771
Product TypeHuman Prescription Drug
Proprietary NameValacyclovir
Generic NameValacyclovir
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2015-05-25
Marketing CategoryANDA / ANDA
Application NumberANDA203047
Labeler NamePD-Rx 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 Through2019-12-31

Packaging

NDC 43063-771-06

6 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-771-06)
Marketing Start Date2017-06-08
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 43063-771-20 [43063077120]

Valacyclovir TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA203047
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-03-26

NDC 43063-771-21 [43063077121]

Valacyclovir TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA203047
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-08-11

NDC 43063-771-06 [43063077106]

Valacyclovir TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA203047
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-06-08

NDC 43063-771-14 [43063077114]

Valacyclovir TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA203047
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-03-23

Drug Details

Active Ingredients

IngredientStrength
VALACYCLOVIR HYDROCHLORIDE1 g/1

OpenFDA Data

SPL SET ID:1b11361c-5444-498b-ab7c-fbad917705ae
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 313564
    • UPC Code
  • 0343063771068

    • 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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