NDC 51817-171

Ganciclovir

Ganciclovir Sodium

Ganciclovir is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Pharmascience Inc.. The primary component is Ganciclovir Sodium.

Product ID51817-171_50d03656-3823-4955-a19c-5236736f8459
NDC51817-171
Product TypeHuman Prescription Drug
Proprietary NameGanciclovir
Generic NameGanciclovir Sodium
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2018-04-24
Marketing CategoryANDA / ANDA
Application NumberANDA207645
Labeler NamePharmascience 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 Through2020-12-31

Packaging

NDC 51817-171-01

25 VIAL in 1 CARTON (51817-171-01) > 10 mL in 1 VIAL
Marketing Start Date2018-04-24
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 51817-171-01 [51817017101]

Ganciclovir INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA207645
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-04-24

Drug Details

Active Ingredients

IngredientStrength
GANCICLOVIR SODIUM500 mg/10mL

OpenFDA Data

SPL SET ID:3059c2da-d4a7-4aea-828c-20e671cb875c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1999531

    • 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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