NDC 0004-6940

Cytovene IV

Ganciclovir Sodium

Cytovene IV is a Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Genentech, Inc.. The primary component is Ganciclovir Sodium.

Product ID0004-6940_702bbdd0-938c-4af5-91aa-c7480db9578e
NDC0004-6940
Product TypeHuman Prescription Drug
Proprietary NameCytovene IV
Generic NameGanciclovir Sodium
Dosage FormInjection, Powder, Lyophilized, For Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date1989-06-23
Marketing CategoryNDA / NDA
Application NumberNDA019661
Labeler NameGenentech, Inc.
Substance NameGANCICLOVIR SODIUM
Active Ingredient Strength500 mg/10mL
Pharm ClassesCytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],DNA Polymerase Inhibitors [MoA],Nucleoside Analog [EXT],Nucleoside Analog Antiviral [EPC]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 0004-6940-04

5 VIAL in 1 CARTON (0004-6940-04) > 10 mL in 1 VIAL
Marketing Start Date1989-06-23
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0004-6940-03 [00004694003]

Cytovene IV INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryNDA
Application NumberNDA019661
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1989-06-23
Marketing End Date2017-11-30

NDC 0004-6940-04 [00004694004]

Cytovene IV INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryNDA
Application NumberNDA019661
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1989-06-23
Marketing End Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
GANCICLOVIR SODIUM500 mg/10mL

OpenFDA Data

SPL SET ID:38e8f819-985c-4d20-aafd-3ba953af26ca
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 205743
  • 310442
  • 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 "Cytovene IV" or generic name "Ganciclovir Sodium"

    NDCBrand NameGeneric Name
    0004-6940Cytoveneganciclovir sodium
    61269-450Cytoveneganciclovir sodium
    0143-9299GanciclovirGanciclovir sodium
    14335-030Ganciclovirganciclovir sodium
    25021-185ganciclovirganciclovir sodium
    51817-171Ganciclovirganciclovir sodium
    63323-315GanciclovirGANCICLOVIR SODIUM
    70436-089Ganciclovirganciclovir sodium
    76233-072GanciclovirGanciclovir Sodium

    Trademark Results [Cytovene]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    CYTOVENE
    CYTOVENE
    73632978 1444841 Live/Registered
    SYNTEX (U.S.A.) INC.
    1986-11-28

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