NDC 25021-185

ganciclovir

Ganciclovir Sodium

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

Product ID25021-185_696f706f-39d7-4647-a506-2ebf7b956cc1
NDC25021-185
Product TypeHuman Prescription Drug
Proprietary Nameganciclovir
Generic NameGanciclovir Sodium
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2018-02-15
Marketing CategoryANDA / ANDA
Application NumberANDA207645
Labeler NameSagent Pharmaceuticals
Substance NameGANCICLOVIR SODIUM
Active Ingredient Strength50 mg/mL
Pharm ClassesCytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], DNA Polymerase Inhibitors [MoA], Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 25021-185-10

25 VIAL in 1 CARTON (25021-185-10) > 10 mL in 1 VIAL
Marketing Start Date2018-02-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 25021-185-10 [25021018510]

ganciclovir INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA207645
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2018-02-15

NDC 25021-185-11 [25021018511]

ganciclovir INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA207645
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-12-15

Drug Details

Active Ingredients

IngredientStrength
GANCICLOVIR SODIUM50 mg/mL

OpenFDA Data

SPL SET ID:993151ed-cea7-49a7-a967-fac3e9b3c85f
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]

    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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