NDC 63304-637

GANCICLOVIR

Ganciclovir

GANCICLOVIR is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Ranbaxy Pharmaceuticals Inc.. The primary component is Ganciclovir.

Product ID63304-637_3406db8a-5ae9-4120-94bd-036701adbeca
NDC63304-637
Product TypeHuman Prescription Drug
Proprietary NameGANCICLOVIR
Generic NameGanciclovir
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2003-08-27
Marketing CategoryANDA / ANDA
Application NumberANDA076457
Labeler NameRanbaxy Pharmaceuticals Inc.
Substance NameGANCICLOVIR
Active Ingredient Strength500 mg/1
Pharm ClassesCytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],DNA Polymerase Inhibitors [MoA],Nucleoside Analog [EXT],Nucleoside Analog Antiviral [EPC]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 63304-637-28

180 CAPSULE in 1 BOTTLE (63304-637-28)
Marketing Start Date2003-08-27
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63304-637-28 [63304063728]

GANCICLOVIR CAPSULE
Marketing CategoryANDA
Application NumberANDA076457
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2003-08-27
Inactivation Date2019-11-13

NDC 63304-637-05 [63304063705]

GANCICLOVIR CAPSULE
Marketing CategoryANDA
Application NumberANDA076457
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2003-08-27
Inactivation Date2019-11-13

NDC 63304-637-60 [63304063760]

GANCICLOVIR CAPSULE
Marketing CategoryANDA
Application NumberANDA076457
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2003-08-27
Inactivation Date2019-11-13

NDC 63304-637-90 [63304063790]

GANCICLOVIR CAPSULE
Marketing CategoryANDA
Application NumberANDA076457
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2003-08-27
Inactivation Date2019-11-13

Drug Details

Active Ingredients

IngredientStrength
GANCICLOVIR500 mg/1

OpenFDA Data

SPL SET ID:3406db8a-5ae9-4120-94bd-036701adbeca
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 200206
  • 314007
  • UPC Code
  • 0363304637908
  • 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"

    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
    24208-535ZIRGANganciclovir

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.