NDC 69097-277

Valganciclovir

Valganciclovir

Valganciclovir is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Cipla Usa Inc.. The primary component is Valganciclovir Hydrochloride.

Product ID69097-277_2349de0d-ed5f-402a-984f-d5d080d1d74a
NDC69097-277
Product TypeHuman Prescription Drug
Proprietary NameValganciclovir
Generic NameValganciclovir
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2018-11-12
Marketing CategoryANDA / ANDA
Application NumberANDA209672
Labeler NameCipla USA Inc.
Substance NameVALGANCICLOVIR HYDROCHLORIDE
Active Ingredient Strength450 mg/1
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 69097-277-03

60 TABLET in 1 BOTTLE (69097-277-03)
Marketing Start Date2018-11-12
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 69097-277-03 [69097027703]

Valganciclovir TABLET
Marketing CategoryANDA
Application NumberANDA209672
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-11-12

Drug Details

Active Ingredients

IngredientStrength
VALGANCICLOVIR HYDROCHLORIDE450 mg/1

OpenFDA Data

SPL SET ID:075130f8-b1f3-4f41-8a82-c1fcb8e3eede
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 313566
  • UPC Code
  • 0369097277031
  • 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]

    Medicade Reported Pricing

    69097027703 VALGANCICLOVIR 450 MG TABLET

    Pricing Unit: EA | Drug Type:

    NDC Crossover Matching brand name "Valganciclovir" or generic name "Valganciclovir"

    NDCBrand NameGeneric Name
    0603-6330ValganciclovirValganciclovir hydrochloride
    0904-6796ValganciclovirValganciclovir
    16714-765ValganciclovirValganciclovir
    27241-158ValganciclovirValganciclovir
    31722-832ValganciclovirValganciclovir
    31722-837VALGANCICLOVIRVALGANCICLOVIR HYDROCHLORIDE
    42291-875ValganciclovirValganciclovir hydrochloride
    48433-124ValganciclovirValganciclovir
    50268-787ValganciclovirValganciclovir
    55111-762ValganciclovirValganciclovir
    59651-444ValganciclovirValganciclovir hydrochloride powder,
    60429-846ValganciclovirValganciclovir
    63629-2288ValganciclovirValganciclovir hydrochloride
    63739-076ValganciclovirValganciclovir
    64380-153ValganciclovirValganciclovir hydrochloride
    68084-965ValganciclovirValganciclovir
    69097-277ValganciclovirValganciclovir
    0004-0038Valcytevalganciclovir

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