NDC 0591-2579

Valganciclovir hydrochloride for Oral

Valganciclovir Hydrochloride

Valganciclovir hydrochloride for Oral is a Oral Powder, For Solution in the Human Prescription Drug category. It is labeled and distributed by Actavis Pharma, Inc.. The primary component is Valganciclovir Hydrochloride.

Product ID0591-2579_0a516d31-2344-4f67-b459-e85088ecc2f3
NDC0591-2579
Product TypeHuman Prescription Drug
Proprietary NameValganciclovir hydrochloride for Oral
Generic NameValganciclovir Hydrochloride
Dosage FormPowder, For Solution
Route of AdministrationORAL
Marketing Start Date2016-08-26
Marketing CategoryANDA / ANDA
Application NumberANDA205220
Labeler NameActavis Pharma, Inc.
Substance NameVALGANCICLOVIR HYDROCHLORIDE
Active Ingredient Strength50 mg/mL
Pharm ClassesCytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], DNA Polymerase Inhibitors [MoA], Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 0591-2579-20

100 mL in 1 BOTTLE, GLASS (0591-2579-20)
Marketing Start Date2016-08-26
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0591-2579-20 [00591257920]

Valganciclovir hydrochloride for Oral POWDER, FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA205220
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2016-08-26

Drug Details

Active Ingredients

IngredientStrength
VALGANCICLOVIR HYDROCHLORIDE50 mg/mL

OpenFDA Data

SPL SET ID:92281301-5fb5-4eea-8766-4863e241c234
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 863559

    • 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 "Valganciclovir hydrochloride for Oral" or generic name "Valganciclovir Hydrochloride"

    NDCBrand NameGeneric Name
    0591-2579Valganciclovir hydrochloride for OralValganciclovir hydrochloride
    0004-0039Valcytevalganciclovir hydrochloride
    0603-6330ValganciclovirValganciclovir hydrochloride
    31722-837VALGANCICLOVIRVALGANCICLOVIR HYDROCHLORIDE
    42291-875ValganciclovirValganciclovir hydrochloride
    63629-2288ValganciclovirValganciclovir hydrochloride
    64380-153ValganciclovirValganciclovir hydrochloride
    27241-159Valganciclovir hydrochlorideValganciclovir hydrochloride
    43598-356valganciclovir hydrochloridevalganciclovir hydrochloride
    63739-357VALGANCICLOVIR HYDROCHLORIDEVALGANCICLOVIR HYDROCHLORIDE
    65862-753VALGANCICLOVIR HYDROCHLORIDEVALGANCICLOVIR HYDROCHLORIDE
    72205-019valganciclovir hydrochloridevalganciclovir hydrochloride
    © 2025 FDA.report
    This site is not affiliated with or endorsed by the FDA.