NDC 68084-965

Valganciclovir

Valganciclovir

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

Product ID68084-965_68f6e2b9-6e03-3e99-e053-2991aa0a9ccd
NDC68084-965
Product TypeHuman Prescription Drug
Proprietary NameValganciclovir
Generic NameValganciclovir
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2015-01-07
Marketing CategoryANDA / ANDA
Application NumberANDA203511
Labeler NameAmerican Health Packaging
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 Through2019-12-31

Packaging

NDC 68084-965-25

30 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-965-25) > 1 TABLET, FILM COATED in 1 BLISTER PACK (68084-965-95)
Marketing Start Date2015-01-07
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68084-965-95 [68084096595]

Valganciclovir TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA203511
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-01-07

NDC 68084-965-25 [68084096525]

Valganciclovir TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA203511
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-01-07

Drug Details

Active Ingredients

IngredientStrength
VALGANCICLOVIR HYDROCHLORIDE450 mg/1

OpenFDA Data

SPL SET ID:4db6dd63-e56b-45a4-86b2-ee125a1854a0
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 313566

    • Pharmacological Class

    • Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC]
    • DNA Polymerase Inhibitors [MoA]
    • Nucleoside Analog [EXT]
    • Nucleoside Analog Antiviral [EPC]

    Medicade Reported Pricing

    68084096595 VALGANCICLOVIR 450 MG TABLET

    Pricing Unit: EA | Drug Type:

    68084096525 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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