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    NDC 31722-0837-10 VALGANCICLOVIR 50 mg/mL Details

    VALGANCICLOVIR 50 mg/mL

    VALGANCICLOVIR is a ORAL POWDER, FOR SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Camber Pharmaceuticals, Inc.. The primary component is VALGANCICLOVIR HYDROCHLORIDE.

    Product Information

    NDC 31722-0837
    Product ID 31722-837_eaad537e-d8e5-24a2-e053-2a95a90ad075
    Associated GPIs
    GCN Sequence Number 064506
    GCN Sequence Number Description valganciclovir HCl SOLN RECON 50 MG/ML ORAL
    HIC3 W5A
    HIC3 Description ANTIVIRALS, GENERAL
    GCN 14453
    HICL Sequence Number 022033
    HICL Sequence Number Description VALGANCICLOVIR HCL
    Brand/Generic Generic
    Proprietary Name VALGANCICLOVIR
    Proprietary Name Suffix n/a
    Non-Proprietary Name VALGANCICLOVIR HYDROCHLORIDE
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form POWDER, FOR SOLUTION
    Route ORAL
    Active Ingredient Strength 50
    Active Ingredient Units mg/mL
    Substance Name VALGANCICLOVIR HYDROCHLORIDE
    Labeler Name Camber Pharmaceuticals, Inc.
    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 ANDA211475
    Listing Certified Through 2024-12-31

    Package

    NDC 31722-0837-10 (31722083710)

    NDC Package Code 31722-837-10
    Billing NDC 31722083710
    Package 1 BOTTLE, GLASS in 1 CARTON (31722-837-10) / 100 mL in 1 BOTTLE, GLASS
    Marketing Start Date 2022-10-04
    NDC Exclude Flag N
    Pricing Information N/A

    Standard Product Labeling (SPL)/Prescribing Information SPL 28703782-9f48-4866-a32d-1604da9dee6b Details

    Revised: 10/2022