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    NDC 67457-0153-09 Amiodarone Hydrochloride 50 mg/mL Details

    Amiodarone Hydrochloride 50 mg/mL

    Amiodarone Hydrochloride is a INTRAVENOUS INJECTION, SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Mylan Institutional LLC. The primary component is AMIODARONE HYDROCHLORIDE.

    Product Information

    NDC 67457-0153
    Product ID 67457-153_bd9c578c-322f-41fc-936d-bf9b551a2782
    Associated GPIs 35400005002030 35400005002040 35400005002050
    GCN Sequence Number 050676
    GCN Sequence Number Description amiodarone HCl VIAL 50 MG/ML INTRAVEN
    HIC3 A2A
    HIC3 Description ANTIARRHYTHMICS
    GCN 17795
    HICL Sequence Number 000083
    HICL Sequence Number Description AMIODARONE HCL
    Brand/Generic Generic
    Proprietary Name Amiodarone Hydrochloride
    Proprietary Name Suffix n/a
    Non-Proprietary Name amiodarone hydrochloride
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form INJECTION, SOLUTION
    Route INTRAVENOUS
    Active Ingredient Strength 50
    Active Ingredient Units mg/mL
    Substance Name AMIODARONE HYDROCHLORIDE
    Labeler Name Mylan Institutional LLC
    Pharmaceutical Class Antiarrhythmic [EPC], Cytochrome P450 1A2 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA076217
    Listing Certified Through 2024-12-31

    Package

    NDC 67457-0153-09 (67457015309)

    NDC Package Code 67457-153-09
    Billing NDC 67457015309
    Package 10 VIAL, GLASS in 1 CARTON (67457-153-09) / 9 mL in 1 VIAL, GLASS (67457-153-99)
    Marketing Start Date 2004-01-05
    NDC Exclude Flag N
    Pricing Information N/A

    Standard Product Labeling (SPL)/Prescribing Information SPL fcc8658c-761a-443f-8c32-1499d86028ec Details

    Revised: 7/2020