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    NDC 76282-0238-05 Amlodipine besylate 5 mg/1 Details

    Amlodipine besylate 5 mg/1

    Amlodipine besylate is a ORAL TABLET in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Exelan Pharmaceuticals, Inc.. The primary component is AMLODIPINE BESYLATE.

    Product Information

    NDC 76282-0238
    Product ID 76282-238_44d49d27-9fc5-42f5-9366-be150a8d47ea
    Associated GPIs 34000003100330
    GCN Sequence Number 016926
    GCN Sequence Number Description amlodipine besylate TABLET 5 MG ORAL
    HIC3 A9A
    HIC3 Description CALCIUM CHANNEL BLOCKING AGENTS
    GCN 02683
    HICL Sequence Number 006494
    HICL Sequence Number Description AMLODIPINE BESYLATE
    Brand/Generic Generic
    Proprietary Name Amlodipine besylate
    Proprietary Name Suffix n/a
    Non-Proprietary Name Amlodipine besylate
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form TABLET
    Route ORAL
    Active Ingredient Strength 5
    Active Ingredient Units mg/1
    Substance Name AMLODIPINE BESYLATE
    Labeler Name Exelan Pharmaceuticals, Inc.
    Pharmaceutical Class Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA077955
    Listing Certified Through 2024-12-31

    Package

    NDC 76282-0238-05 (76282023805)

    NDC Package Code 76282-238-05
    Billing NDC 76282023805
    Package 500 TABLET in 1 BOTTLE (76282-238-05)
    Marketing Start Date 2007-11-02
    NDC Exclude Flag N
    Pricing Information N/A