NDC 55289-926

VALTREX

Valacyclovir Hydrochloride

VALTREX 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 ID55289-926_7bbcacd0-85df-18b0-e053-2a91aa0a7fc1
NDC55289-926
Product TypeHuman Prescription Drug
Proprietary NameVALTREX
Generic NameValacyclovir Hydrochloride
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date1995-08-01
Marketing CategoryNDA / NDA
Application NumberNDA020487
Labeler NamePD-Rx 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 55289-926-14

14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-926-14)
Marketing Start Date2011-12-16
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 55289-926-08 [55289092608]

VALTREX TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA020487
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2011-12-16
Marketing End Date2019-09-12

NDC 55289-926-07 [55289092607]

VALTREX TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA020487
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2011-12-16
Marketing End Date2019-09-12

NDC 55289-926-14 [55289092614]

VALTREX TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA020487
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2011-12-16
Marketing End Date2019-09-12

NDC 55289-926-06 [55289092606]

VALTREX TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA020487
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2011-12-16
Marketing End Date2019-09-12

NDC 55289-926-04 [55289092604]

VALTREX TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA020487
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2011-12-16
Marketing End Date2019-09-12

NDC 55289-926-10 [55289092610]

VALTREX TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA020487
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2011-12-16
Marketing End Date2019-09-12

Drug Details

Active Ingredients

IngredientStrength
VALACYCLOVIR HYDROCHLORIDE500 mg/1

OpenFDA Data

SPL SET ID:d8028584-4186-41d6-b74b-2535971aa216
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 108780
  • 313565
    • UPC Code
  • 0355289926047

    • 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 "VALTREX" or generic name "Valacyclovir Hydrochloride"

    NDCBrand NameGeneric Name
    0173-0565VALTREXvalacyclovir hydrochloride
    0173-0933VALTREXvalacyclovir hydrochloride
    50090-0753VALTREXVALTREX
    55289-926VALTREXVALTREX
    63629-3982VALTREXVALTREX
    70518-2039VALTREXVALTREX
    67296-0200VALTREXVALTREX
    0378-4275Valacyclovir Hydrochloridevalacyclovir hydrochloride
    0378-4276Valacyclovir Hydrochloridevalacyclovir hydrochloride
    0781-5208Valacyclovir HydrochlorideValacyclovir Hydrochloride
    0781-5209Valacyclovir HydrochlorideValacyclovir Hydrochloride
    0904-6565Valacyclovir HydrochlorideValacyclovir Hydrochloride
    10544-937valacyclovir hydrochloridevalacyclovir hydrochloride
    16714-697Valacyclovir HydrochlorideValacyclovir Hydrochloride
    16714-698Valacyclovir HydrochlorideValacyclovir Hydrochloride
    21695-832Valacyclovir HydrochlorideValacyclovir Hydrochloride
    21695-965Valacyclovir HydrochlorideValacyclovir Hydrochloride
    43063-200Valacyclovir HydrochlorideValacyclovir Hydrochloride

    Trademark Results [VALTREX]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    VALTREX
    VALTREX
    74643955 2053301 Live/Registered
    GLAXOSMITHKLINE LLC
    1995-03-09
    VALTREX
    VALTREX
    74423957 1879098 Live/Registered
    GLAXOSMITHKLINE LLC
    1993-08-12
    VALTREX
    VALTREX
    74138827 not registered Dead/Abandoned
    CHEVRON CHEMICAL COMPANY
    1991-02-13
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