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    NDC 78206-0140-01 HYZAAR 12.5; 100 mg/1; mg/1 Details

    HYZAAR 12.5; 100 mg/1; mg/1

    HYZAAR is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Organon LLC. The primary component is HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM.

    Product Information

    NDC 78206-0140
    Product ID 78206-140_523001d3-24b4-4b24-8b40-47799b751880
    Associated GPIs 36994002450325
    GCN Sequence Number 059919
    GCN Sequence Number Description losartan/hydrochlorothiazide TABLET 100-12.5MG ORAL
    HIC3 A4I
    HIC3 Description ANGIOTENSIN RECEPTOR ANTAG.-THIAZIDE DIURETIC COMB
    GCN 25851
    HICL Sequence Number 009863
    HICL Sequence Number Description LOSARTAN POTASSIUM/HYDROCHLOROTHIAZIDE
    Brand/Generic Brand
    Proprietary Name HYZAAR
    Proprietary Name Suffix n/a
    Non-Proprietary Name losartan potassium and hydrochlorothiazide
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form TABLET, FILM COATED
    Route ORAL
    Active Ingredient Strength 12.5; 100
    Active Ingredient Units mg/1; mg/1
    Substance Name HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM
    Labeler Name Organon LLC
    Pharmaceutical Class Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]
    DEA Schedule n/a
    Marketing Category NDA
    Application Number NDA020387
    Listing Certified Through 2024-12-31

    Package

    NDC 78206-0140-01 (78206014001)

    NDC Package Code 78206-140-01
    Billing NDC 78206014001
    Package 30 TABLET, FILM COATED in 1 BOTTLE (78206-140-01)
    Marketing Start Date 2021-06-01
    NDC Exclude Flag N
    Pricing Information N/A