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    NDC 68462-0569-14 Amlodipine and Olmesartan Medoxomil 10; 40 mg/1; mg/1 Details

    Amlodipine and Olmesartan Medoxomil 10; 40 mg/1; mg/1

    Amlodipine and Olmesartan Medoxomil is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Glenmark Pharmaceuticals Inc., USA. The primary component is AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL.

    Product Information

    NDC 68462-0569
    Product ID 68462-569_6de4a776-9973-4410-ae04-99544813d920
    Associated GPIs 36993002050340
    GCN Sequence Number 063182
    GCN Sequence Number Description amlodipine bes/olmesartan med TABLET 10 MG-40MG ORAL
    HIC3 A4H
    HIC3 Description ANGIOTENSIN RECEPTOR BLOCKR-CALCIUM CHANNEL BLOCKR
    GCN 98939
    HICL Sequence Number 035042
    HICL Sequence Number Description AMLODIPINE BESYLATE/OLMESARTAN MEDOXOMIL
    Brand/Generic Generic
    Proprietary Name Amlodipine and Olmesartan Medoxomil
    Proprietary Name Suffix n/a
    Non-Proprietary Name Amlodipine and Olmesartan Medoxomil
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form TABLET, FILM COATED
    Route ORAL
    Active Ingredient Strength 10; 40
    Active Ingredient Units mg/1; mg/1
    Substance Name AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL
    Labeler Name Glenmark Pharmaceuticals Inc., USA
    Pharmaceutical Class Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], 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 ANDA207807
    Listing Certified Through 2025-12-31

    Package

    NDC 68462-0569-14 (68462056914)

    NDC Package Code 68462-569-14
    Billing NDC 68462056914
    Package 10 BLISTER PACK in 1 CARTON (68462-569-14) / 10 TABLET, FILM COATED in 1 BLISTER PACK
    Marketing Start Date 2017-07-05
    NDC Exclude Flag N
    Pricing Information N/A