NDC 16714-765

Valganciclovir

Valganciclovir

Valganciclovir is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Northstar Rx Llc. The primary component is Valganciclovir Hydrochloride.

Product ID16714-765_15c15c99-1059-d8ee-0992-9a6c422f3496
NDC16714-765
Product TypeHuman Prescription Drug
Proprietary NameValganciclovir
Generic NameValganciclovir
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2018-03-10
Marketing CategoryANDA / ANDA
Application NumberANDA203511
Labeler NameNorthStar Rx LLC
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 16714-765-01

60 TABLET, FILM COATED in 1 BOTTLE (16714-765-01)
Marketing Start Date2018-03-10
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 16714-765-01 [16714076501]

Valganciclovir TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA203511
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-03-10

Drug Details

Active Ingredients

IngredientStrength
VALGANCICLOVIR HYDROCHLORIDE450 mg/1

OpenFDA Data

SPL SET ID:61047c97-e01b-9708-1b3d-849179695f43
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 313566
    • UPC Code
  • 0316714765013

    • 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

    16714076501 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
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