NDC 63323-315

Ganciclovir

Ganciclovir Sodium

Ganciclovir is a Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Fresenius Kabi Usa, Llc. The primary component is Ganciclovir Sodium.

Product ID63323-315_69308417-946f-47cd-abb1-98c749d09492
NDC63323-315
Product TypeHuman Prescription Drug
Proprietary NameGanciclovir
Generic NameGanciclovir Sodium
Dosage FormInjection, Powder, Lyophilized, For Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2010-06-28
Marketing CategoryANDA / ANDA
Application NumberANDA090658
Labeler NameFresenius Kabi USA, LLC
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 Through2021-12-31

Packaging

NDC 63323-315-94

25 VIAL in 1 TRAY (63323-315-94) > 10 mL in 1 VIAL (63323-315-41)
Marketing Start Date2010-06-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63323-315-94 [63323031594]

Ganciclovir INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA090658
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-06-28

NDC 63323-315-10 [63323031510]

Ganciclovir INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA090658
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-06-28

Drug Details

Active Ingredients

IngredientStrength
GANCICLOVIR SODIUM500 mg/10mL

OpenFDA Data

SPL SET ID:b47f5d1c-36b8-49b6-a410-3b3f4661dde7
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 310442
    • UPC Code
  • 0363323315108

    • 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 "Ganciclovir" or generic name "Ganciclovir Sodium"

    NDCBrand NameGeneric Name
    0143-9299GanciclovirGanciclovir sodium
    14335-030Ganciclovirganciclovir sodium
    24201-500GanciclovirGanciclovir
    25021-185ganciclovirganciclovir sodium
    42023-173GanciclovirGanciclovir
    51754-2500GANCICLOVIRGANCICLOVIR
    51817-171Ganciclovirganciclovir sodium
    63304-636GANCICLOVIRGANCICLOVIR
    63304-637GANCICLOVIRGANCICLOVIR
    63323-315GanciclovirGANCICLOVIR SODIUM
    70436-089Ganciclovirganciclovir sodium
    76233-072GanciclovirGanciclovir Sodium
    0004-6940Cytoveneganciclovir sodium
    61269-450Cytoveneganciclovir sodium
    24208-535ZIRGANganciclovir
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