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    NDC 63323-0659-94 Indomethacin 1 mg/mL Details

    Indomethacin 1 mg/mL

    Indomethacin 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 INDOMETHACIN.

    Product Information

    NDC 63323-0659
    Product ID 63323-659_f77a01f1-d5ef-4894-aba1-cd23e3ee4e7b
    Associated GPIs 66100030102105
    GCN Sequence Number 008335
    GCN Sequence Number Description indomethacin sodium VIAL 1 MG INTRAVEN
    HIC3 A5A
    HIC3 Description PATENT DUCTUS ARTERIOSUS TREAT. AGENTS, NSAID-TYPE
    GCN 34690
    HICL Sequence Number 003718
    HICL Sequence Number Description INDOMETHACIN SODIUM
    Brand/Generic Generic
    Proprietary Name Indomethacin
    Proprietary Name Suffix n/a
    Non-Proprietary Name INDOMETHACIN
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
    Route INTRAVENOUS
    Active Ingredient Strength 1
    Active Ingredient Units mg/mL
    Substance Name INDOMETHACIN
    Labeler Name Fresenius Kabi USA, LLC
    Pharmaceutical Class Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
    DEA Schedule n/a
    Marketing Category NDA
    Application Number NDA022536
    Listing Certified Through 2024-12-31

    Package

    NDC 63323-0659-94 (63323065994)

    NDC Package Code 63323-659-94
    Billing NDC 63323065994
    Package 1 VIAL in 1 CARTON (63323-659-94) / 1 mL in 1 VIAL
    Marketing Start Date 2010-03-19
    NDC Exclude Flag N
    Pricing Information N/A