NDC 14335-030

Ganciclovir

Ganciclovir Sodium

Ganciclovir is a Intraventricular Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Hainan Poly Pharm. Co., Ltd.. The primary component is Ganciclovir Sodium.

Product ID14335-030_80b86c46-230e-0090-e053-2991aa0a8fc1
NDC14335-030
Product TypeHuman Prescription Drug
Proprietary NameGanciclovir
Generic NameGanciclovir Sodium
Dosage FormInjection, Powder, Lyophilized, For Solution
Route of AdministrationINTRAVENTRICULAR
Marketing Start Date2019-02-11
Marketing CategoryANDA / ANDA
Application NumberANDA204204
Labeler NameHainan Poly Pharm. Co., Ltd.
Substance NameGANCICLOVIR SODIUM
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 Through2020-12-31

Packaging

NDC 14335-030-01

10 VIAL in 1 CARTON (14335-030-01) > 10 mL in 1 VIAL
Marketing Start Date2019-02-11
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 14335-030-01 [14335003001]

Ganciclovir INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA204204
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-02-11

NDC 14335-030-25 [14335003025]

Ganciclovir INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA204204
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-02-11

Drug Details

Active Ingredients

IngredientStrength
GANCICLOVIR SODIUM50 mg/mL

OpenFDA Data

SPL SET ID:69017374-ac20-4b8c-86c7-d35907046dce
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 310442

    • 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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