NDC 42291-875

Valganciclovir

Valganciclovir Hydrochloride

Valganciclovir is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Avkare, Inc.. The primary component is Valganciclovir Hydrochloride.

Product ID42291-875_641a7be4-094c-1f65-e053-2a91aa0a259e
NDC42291-875
Product TypeHuman Prescription Drug
Proprietary NameValganciclovir
Generic NameValganciclovir Hydrochloride
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2016-06-21
Marketing CategoryANDA / ANDA
Application NumberANDA200790
Labeler NameAvKARE, Inc.
Substance NameVALGANCICLOVIR HYDROCHLORIDE
Active Ingredient Strength450 mg/1
Pharm ClassesCytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],DNA Polymerase Inhibitors [MoA],Nucleoside Analog [EXT],Nucleoside Analog Antiviral [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 42291-875-60

60 TABLET, FILM COATED in 1 BOTTLE (42291-875-60)
Marketing Start Date2016-06-21
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 42291-875-60 [42291087560]

Valganciclovir TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA200790
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-06-21

Drug Details

Active Ingredients

IngredientStrength
VALGANCICLOVIR HYDROCHLORIDE450 mg/1

OpenFDA Data

SPL SET ID:7e6ecffa-705b-2319-011c-dd8ca375c279
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 313566
    • UPC Code
  • 0342291875609

    • Pharmacological Class

    • Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC]
    • DNA Polymerase Inhibitors [MoA]
    • Nucleoside Analog [EXT]
    • Nucleoside Analog Antiviral [EPC]
    • Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC]
    • DNA Polymerase Inhibitors [MoA]
    • Nucleoside Analog [EXT]
    • Nucleoside Analog Antiviral [EPC]

    NDC Crossover Matching brand name "Valganciclovir" or generic name "Valganciclovir Hydrochloride"

    NDCBrand NameGeneric Name
    0603-6330ValganciclovirValganciclovir hydrochloride
    0904-6796ValganciclovirValganciclovir
    16714-765ValganciclovirValganciclovir
    27241-158ValganciclovirValganciclovir
    31722-832ValganciclovirValganciclovir
    31722-837VALGANCICLOVIRVALGANCICLOVIR HYDROCHLORIDE
    42291-875ValganciclovirValganciclovir hydrochloride
    48433-124ValganciclovirValganciclovir
    50268-787ValganciclovirValganciclovir
    68084-965ValganciclovirValganciclovir
    69097-277ValganciclovirValganciclovir
    55111-762ValganciclovirValganciclovir
    60429-846ValganciclovirValganciclovir
    0004-0038Valcytevalganciclovir
    0004-0039Valcytevalganciclovir hydrochloride
    27241-159Valganciclovir hydrochlorideValganciclovir hydrochloride
    43598-356valganciclovir hydrochloridevalganciclovir hydrochloride
    0591-2579Valganciclovir hydrochloride for OralValganciclovir hydrochloride
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