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    NDC 76282-0239-05 Amlodipine besylate 10 mg/1 Details

    Amlodipine besylate 10 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 76282-0239
    Product ID 76282-239_44d49d27-9fc5-42f5-9366-be150a8d47ea
    Associated GPIs 34000003100340
    GCN Sequence Number 016927
    GCN Sequence Number Description amlodipine besylate TABLET 10 MG ORAL
    HIC3 A9A
    HIC3 Description CALCIUM CHANNEL BLOCKING AGENTS
    GCN 02682
    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 10
    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 76282-0239-05 (76282023905)

    NDC Package Code 76282-239-05
    Billing NDC 76282023905
    Package 500 TABLET in 1 BOTTLE (76282-239-05)
    Marketing Start Date 2007-11-02
    NDC Exclude Flag N
    Pricing Information N/A