NDC 65862-753

VALGANCICLOVIR HYDROCHLORIDE

Valganciclovir Hydrochloride

VALGANCICLOVIR HYDROCHLORIDE is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Aurobindo Pharma Limited. The primary component is Valganciclovir Hydrochloride.

Product ID65862-753_11d7eae2-53f4-4f8c-b5aa-4e99f3e747e5
NDC65862-753
Product TypeHuman Prescription Drug
Proprietary NameVALGANCICLOVIR HYDROCHLORIDE
Generic NameValganciclovir Hydrochloride
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2016-03-31
Marketing CategoryANDA / ANDA
Application NumberANDA204750
Labeler NameAurobindo Pharma Limited
Substance NameVALGANCICLOVIR HYDROCHLORIDE
Active Ingredient Strength450 mg/1
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 65862-753-01

100 TABLET in 1 BOTTLE (65862-753-01)
Marketing Start Date2016-03-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 65862-753-99 [65862075399]

VALGANCICLOVIR HYDROCHLORIDE TABLET
Marketing CategoryANDA
Application NumberANDA204750
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-03-31

NDC 65862-753-01 [65862075301]

VALGANCICLOVIR HYDROCHLORIDE TABLET
Marketing CategoryANDA
Application NumberANDA204750
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-03-31

NDC 65862-753-60 [65862075360]

VALGANCICLOVIR HYDROCHLORIDE TABLET
Marketing CategoryANDA
Application NumberANDA204750
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-03-31

NDC 65862-753-05 [65862075305]

VALGANCICLOVIR HYDROCHLORIDE TABLET
Marketing CategoryANDA
Application NumberANDA204750
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-03-31

NDC 65862-753-18 [65862075318]

VALGANCICLOVIR HYDROCHLORIDE TABLET
Marketing CategoryANDA
Application NumberANDA204750
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-03-31

Drug Details

Active Ingredients

IngredientStrength
VALGANCICLOVIR HYDROCHLORIDE450 mg/1

OpenFDA Data

SPL SET ID:8d2ffc05-2fbc-41f8-8656-fbc0bfa7ad83
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

    65862075360 VALGANCICLOVIR 450 MG TABLET

    Pricing Unit: EA | Drug Type:

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

    NDCBrand NameGeneric Name
    27241-159Valganciclovir hydrochlorideValganciclovir hydrochloride
    43598-356valganciclovir hydrochloridevalganciclovir hydrochloride
    63739-357VALGANCICLOVIR HYDROCHLORIDEVALGANCICLOVIR HYDROCHLORIDE
    65862-753VALGANCICLOVIR HYDROCHLORIDEVALGANCICLOVIR HYDROCHLORIDE
    70010-051VALGANCICLOVIR HYDROCHLORIDEVALGANCICLOVIR
    70069-810VALGANCICLOVIR HYDROCHLORIDEVALGANCICLOVIR
    72205-019valganciclovir hydrochloridevalganciclovir hydrochloride
    0004-0039Valcytevalganciclovir hydrochloride
    0603-6330ValganciclovirValganciclovir hydrochloride
    31722-837VALGANCICLOVIRVALGANCICLOVIR HYDROCHLORIDE
    42291-875ValganciclovirValganciclovir hydrochloride
    63629-2288ValganciclovirValganciclovir hydrochloride
    64380-153ValganciclovirValganciclovir hydrochloride
    0591-2579Valganciclovir hydrochloride for OralValganciclovir hydrochloride
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