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    NDC 63323-0314-61 Vancomycin Hydrochloride 10 g/100mL Details

    Vancomycin Hydrochloride 10 g/100mL

    Vancomycin Hydrochloride is a INTRAVENOUS INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Fresenius Kabi USA, LLC. The primary component is VANCOMYCIN HYDROCHLORIDE.

    Product Information

    NDC 63323-0314
    Product ID 63323-314_020618ad-8f1f-4189-a95c-254f05a077cc
    Associated GPIs 16280080102130
    GCN Sequence Number 009329
    GCN Sequence Number Description vancomycin HCl VIAL 10 G INTRAVEN
    HIC3 W1J
    HIC3 Description VANCOMYCIN ANTIBIOTICS AND DERIVATIVES
    GCN 41282
    HICL Sequence Number 004042
    HICL Sequence Number Description VANCOMYCIN HCL
    Brand/Generic Generic
    Proprietary Name Vancomycin Hydrochloride
    Proprietary Name Suffix n/a
    Non-Proprietary Name VANCOMYCIN HYDROCHLORIDE
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
    Route INTRAVENOUS
    Active Ingredient Strength 10
    Active Ingredient Units g/100mL
    Substance Name VANCOMYCIN HYDROCHLORIDE
    Labeler Name Fresenius Kabi USA, LLC
    Pharmaceutical Class Glycopeptide Antibacterial [EPC], Glycopeptides [CS]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA062663
    Listing Certified Through 2024-12-31

    Package

    NDC 63323-0314-61 (63323031461)

    NDC Package Code 63323-314-61
    Billing NDC 63323031461
    Package 1 BOTTLE in 1 CARTON (63323-314-61) / 100 mL in 1 BOTTLE
    Marketing Start Date 2004-11-30
    NDC Exclude Flag N
    Pricing Information N/A