NDC 70010-051

VALGANCICLOVIR HYDROCHLORIDE

Valganciclovir

VALGANCICLOVIR HYDROCHLORIDE is a Oral For Solution in the Human Prescription Drug category. It is labeled and distributed by Granules Pharmaceuticals Inc.. The primary component is Valganciclovir.

Product ID70010-051_1dfef3e9-bc14-4ee7-8428-c9fef512d520
NDC70010-051
Product TypeHuman Prescription Drug
Proprietary NameVALGANCICLOVIR HYDROCHLORIDE
Generic NameValganciclovir
Dosage FormFor Solution
Route of AdministrationORAL
Marketing Start Date2020-03-31
Marketing CategoryANDA / ANDA
Application NumberANDA213306
Labeler NameGranules Pharmaceuticals Inc.
Substance NameVALGANCICLOVIR
Active Ingredient Strength50 mg/mL
Pharm ClassesCytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],DNA Polymerase Inhibitors [MoA],Nucleoside Analog [EXT]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 70010-051-40

100 mL in 1 BOTTLE (70010-051-40)
Marketing Start Date2021-07-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70010-051-40 [70010005140]

VALGANCICLOVIR HYDROCHLORIDE FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA213306
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-03-31

Drug Details

Active Ingredients

IngredientStrength
VALGANCICLOVIR50 mg/mL

OpenFDA Data

SPL SET ID:39452b74-161d-4525-a0f7-fe486f001513
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 863559

    • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    27241-159Valganciclovir hydrochlorideValganciclovir hydrochloride
    43598-356valganciclovir hydrochloridevalganciclovir hydrochloride
    63739-357VALGANCICLOVIR HYDROCHLORIDEVALGANCICLOVIR HYDROCHLORIDE
    65862-753VALGANCICLOVIR HYDROCHLORIDEVALGANCICLOVIR HYDROCHLORIDE
    70010-051VALGANCICLOVIR HYDROCHLORIDEVALGANCICLOVIR HYDROCHLORIDE
    0004-0038Valcytevalganciclovir
    0004-0039Valcytevalganciclovir hydrochloride
    0603-6330ValganciclovirValganciclovir hydrochloride
    0904-6796ValganciclovirValganciclovir
    16714-765ValganciclovirValganciclovir
    27241-158ValganciclovirValganciclovir
    31722-832ValganciclovirValganciclovir
    31722-837VALGANCICLOVIRVALGANCICLOVIR HYDROCHLORIDE
    42291-875ValganciclovirValganciclovir hydrochloride
    48433-124ValganciclovirValganciclovir
    50268-787ValganciclovirValganciclovir
    0591-2579Valganciclovir hydrochloride for OralValganciclovir hydrochloride
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