Search by Drug Name or NDC

    NDC 65862-0753-99 VALGANCICLOVIR HYDROCHLORIDE 450 mg/1 Details

    VALGANCICLOVIR HYDROCHLORIDE 450 mg/1

    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 Information

    NDC 65862-0753
    Product ID 65862-753_11d7eae2-53f4-4f8c-b5aa-4e99f3e747e5
    Associated GPIs 12200066100320
    GCN Sequence Number 047797
    GCN Sequence Number Description valganciclovir HCl TABLET 450 MG ORAL
    HIC3 W5A
    HIC3 Description ANTIVIRALS, GENERAL
    GCN 13088
    HICL Sequence Number 022033
    HICL Sequence Number Description VALGANCICLOVIR HCL
    Brand/Generic Generic
    Proprietary Name VALGANCICLOVIR HYDROCHLORIDE
    Proprietary Name Suffix n/a
    Non-Proprietary Name VALGANCICLOVIR HYDROCHLORIDE
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form TABLET
    Route ORAL
    Active Ingredient Strength 450
    Active Ingredient Units mg/1
    Substance Name VALGANCICLOVIR HYDROCHLORIDE
    Labeler Name Aurobindo Pharma Limited
    Pharmaceutical Class Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], DNA Polymerase Inhibitors [MoA], Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA204750
    Listing Certified Through 2024-12-31

    Package

    NDC 65862-0753-99 (65862075399)

    NDC Package Code 65862-753-99
    Billing NDC 65862075399
    Package 1000 TABLET in 1 BOTTLE (65862-753-99)
    Marketing Start Date 2016-03-31
    NDC Exclude Flag N
    Pricing Information N/A

    Standard Product Labeling (SPL)/Prescribing Information SPL 8d2ffc05-2fbc-41f8-8656-fbc0bfa7ad83 Details

    Revised: 7/2022