NDC 0004-0039

Valcyte

Valganciclovir Hydrochloride

Valcyte is a Oral Powder, For Solution in the Human Prescription Drug category. It is labeled and distributed by Genentech, Inc.. The primary component is Valganciclovir Hydrochloride.

Product ID0004-0039_11d60ca4-c31d-4fa4-8606-13541e8dbee2
NDC0004-0039
Product TypeHuman Prescription Drug
Proprietary NameValcyte
Generic NameValganciclovir Hydrochloride
Dosage FormPowder, For Solution
Route of AdministrationORAL
Marketing Start Date2009-08-28
Marketing CategoryNDA / NDA
Application NumberNDA022257
Labeler NameGenentech, Inc.
Substance NameVALGANCICLOVIR HYDROCHLORIDE
Active Ingredient Strength50 mg/mL
Pharm ClassesCytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],DNA Polymerase Inhibitors [MoA],Nucleoside Analog [EXT],Nucleoside Analog Antiviral [EPC]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 0004-0039-09

1 BOTTLE, GLASS in 1 CARTON (0004-0039-09) > 100 mL in 1 BOTTLE, GLASS
Marketing Start Date2009-08-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0004-0039-09 [00004003909]

Valcyte POWDER, FOR SOLUTION
Marketing CategoryNDA
Application NumberNDA022257
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2009-08-28

Drug Details

Active Ingredients

IngredientStrength
VALGANCICLOVIR HYDROCHLORIDE50 mg/mL

OpenFDA Data

SPL SET ID:dc548ff9-e8ea-4d6e-b9b4-e31f53ac4078
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 863562
  • 863559
  • 313566
  • 284587

    • 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 "Valcyte" or generic name "Valganciclovir Hydrochloride"

    NDCBrand NameGeneric Name
    0004-0038Valcytevalganciclovir
    0004-0039Valcytevalganciclovir hydrochloride
    0603-6330ValganciclovirValganciclovir hydrochloride
    31722-837VALGANCICLOVIRVALGANCICLOVIR HYDROCHLORIDE
    42291-875ValganciclovirValganciclovir hydrochloride
    63629-2288ValganciclovirValganciclovir hydrochloride
    64380-153ValganciclovirValganciclovir hydrochloride
    27241-159Valganciclovir hydrochlorideValganciclovir hydrochloride
    43598-356valganciclovir hydrochloridevalganciclovir hydrochloride
    63739-357VALGANCICLOVIR HYDROCHLORIDEVALGANCICLOVIR HYDROCHLORIDE
    65862-753VALGANCICLOVIR HYDROCHLORIDEVALGANCICLOVIR HYDROCHLORIDE
    72205-019valganciclovir hydrochloridevalganciclovir hydrochloride
    0591-2579Valganciclovir hydrochloride for OralValganciclovir hydrochloride

    Trademark Results [Valcyte]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    VALCYTE
    VALCYTE
    76214676 2760715 Live/Registered
    Hoffmann-La Roche Inc.
    2001-02-22
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