NDC 0904-6796

Valganciclovir

Valganciclovir

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

Product ID0904-6796_3d50ba95-55b5-4bc8-b626-adc5f0c5e0cf
NDC0904-6796
Product TypeHuman Prescription Drug
Proprietary NameValganciclovir
Generic NameValganciclovir
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2016-03-18
Marketing CategoryANDA / ANDA
Application NumberANDA205166
Labeler NameMajor Pharmaceuticals
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 Through2022-12-31

Packaging

NDC 0904-6796-04

30 BLISTER PACK in 1 CARTON (0904-6796-04) > 1 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Start Date2016-03-18
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0904-6796-04 [00904679604]

Valganciclovir TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA205166
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-03-18

NDC 0904-6796-10 [00904679610]

Valganciclovir TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA205166
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-03-18

Drug Details

Active Ingredients

IngredientStrength
VALGANCICLOVIR HYDROCHLORIDE450 mg/1

OpenFDA Data

SPL SET ID:6a6533fd-0579-4059-ba87-aa399829a8b0
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 313566

    • Pharmacological Class

    • 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"

    NDCBrand NameGeneric Name
    0603-6330ValganciclovirValganciclovir hydrochloride
    0904-6796ValganciclovirValganciclovir
    16714-765ValganciclovirValganciclovir
    27241-158ValganciclovirValganciclovir
    31722-832ValganciclovirValganciclovir
    31722-837VALGANCICLOVIRVALGANCICLOVIR HYDROCHLORIDE
    42291-875ValganciclovirValganciclovir hydrochloride
    48433-124ValganciclovirValganciclovir
    50268-787ValganciclovirValganciclovir
    55111-762ValganciclovirValganciclovir
    59651-444ValganciclovirValganciclovir hydrochloride powder,
    60429-846ValganciclovirValganciclovir
    63629-2288ValganciclovirValganciclovir hydrochloride
    63739-076ValganciclovirValganciclovir
    64380-153ValganciclovirValganciclovir hydrochloride
    68084-965ValganciclovirValganciclovir
    69097-277ValganciclovirValganciclovir
    0004-0038Valcytevalganciclovir
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