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    NDC 63323-0221-38 Vancomycin Hydrochloride 500 mg/10mL Details

    Vancomycin Hydrochloride 500 mg/10mL

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

    Product Information

    NDC 63323-0221
    Product ID 63323-221_23a89459-d331-4975-84fe-4bfa6ed2c24e
    Associated GPIs 16280080102110
    GCN Sequence Number 009331
    GCN Sequence Number Description vancomycin HCl VIAL 500 MG INTRAVEN
    HIC3 W1J
    HIC3 Description VANCOMYCIN ANTIBIOTICS AND DERIVATIVES
    GCN 41280
    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 500
    Active Ingredient Units mg/10mL
    Substance Name VANCOMYCIN HYDROCHLORIDE
    Labeler Name Fresenius Kabi, LLC
    Pharmaceutical Class Glycopeptide Antibacterial [EPC], Glycopeptides [CS]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA204107
    Listing Certified Through 2024-12-31

    Package

    NDC 63323-0221-38 (63323022138)

    NDC Package Code 63323-221-38
    Billing NDC 63323022138
    Package 25 VIAL in 1 TRAY (63323-221-38) / 10 mL in 1 VIAL (63323-221-33)
    Marketing Start Date 2017-11-01
    NDC Exclude Flag N
    Pricing Information N/A