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    NDC 00245-1645-30 Pacerone 400 mg/1 Details

    Pacerone 400 mg/1

    Pacerone is a ORAL TABLET in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Upsher-Smith Laboratories, LLC. The primary component is AMIODARONE HYDROCHLORIDE.

    Product Information

    NDC 00245-1645
    Product ID 0245-1645_c6c66dbb-cc0b-4576-9248-e20255e83cf0
    Associated GPIs 35400005000320
    GCN Sequence Number 047421
    GCN Sequence Number Description amiodarone HCl TABLET 400 MG ORAL
    HIC3 A2A
    HIC3 Description ANTIARRHYTHMICS
    GCN 12465
    HICL Sequence Number 000083
    HICL Sequence Number Description AMIODARONE HCL
    Brand/Generic Brand
    Proprietary Name Pacerone
    Proprietary Name Suffix n/a
    Non-Proprietary Name Amiodarone Hydrochloride
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form TABLET
    Route ORAL
    Active Ingredient Strength 400
    Active Ingredient Units mg/1
    Substance Name AMIODARONE HYDROCHLORIDE
    Labeler Name Upsher-Smith Laboratories, LLC
    Pharmaceutical Class Antiarrhythmic [EPC], Cytochrome P450 1A2 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA075135
    Listing Certified Through 2024-12-31

    Package

    NDC 00245-1645-30 (00245164530)

    NDC Package Code 0245-1645-30
    Billing NDC 00245164530
    Package 30 TABLET in 1 BOTTLE (0245-1645-30)
    Marketing Start Date 2020-10-01
    NDC Exclude Flag N
    Pricing Information N/A