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    NDC 33342-0190-12 AMLODIPINE and OLMESARTAN medoxomil 5; 20 mg/1; mg/1 Details

    AMLODIPINE and OLMESARTAN medoxomil 5; 20 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 Macleods Pharmaceuticals Limited. The primary component is AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL.

    Product Information

    NDC 33342-0190
    Product ID 33342-190_ec147040-b267-4905-b311-09ebce2080b4
    Associated GPIs 36993002050310
    GCN Sequence Number 063179
    GCN Sequence Number Description amlodipine bes/olmesartan med TABLET 5 MG-20 MG ORAL
    HIC3 A4H
    HIC3 Description ANGIOTENSIN RECEPTOR BLOCKR-CALCIUM CHANNEL BLOCKR
    GCN 98936
    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 5; 20
    Active Ingredient Units mg/1; mg/1
    Substance Name AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL
    Labeler Name Macleods Pharmaceuticals Limited
    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 ANDA206884
    Listing Certified Through 2024-12-31

    Package

    NDC 33342-0190-12 (33342019012)

    NDC Package Code 33342-190-12
    Billing NDC 33342019012
    Package 10 BLISTER PACK in 1 CARTON (33342-190-12) / 10 TABLET, FILM COATED in 1 BLISTER PACK
    Marketing Start Date 2016-10-27
    NDC Exclude Flag N
    Pricing Information N/A