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    NDC 71335-1097-02 Irbesartan and Hydrochlorothiazide 12.5; 150 mg/1; mg/1 Details

    Irbesartan and Hydrochlorothiazide 12.5; 150 mg/1; mg/1

    Irbesartan and Hydrochlorothiazide is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Bryant Ranch Prepack. The primary component is HYDROCHLOROTHIAZIDE; IRBESARTAN.

    Product Information

    NDC 71335-1097
    Product ID 71335-1097_04ca597a-0797-4dd7-b85e-9d9bdcad68c3
    Associated GPIs 36994002300320
    GCN Sequence Number 041234
    GCN Sequence Number Description irbesartan/hydrochlorothiazide TABLET 150-12.5MG ORAL
    HIC3 A4I
    HIC3 Description ANGIOTENSIN RECEPTOR ANTAG.-THIAZIDE DIURETIC COMB
    GCN 11042
    HICL Sequence Number 018963
    HICL Sequence Number Description IRBESARTAN/HYDROCHLOROTHIAZIDE
    Brand/Generic Generic
    Proprietary Name Irbesartan and Hydrochlorothiazide
    Proprietary Name Suffix n/a
    Non-Proprietary Name Irbesartan and Hydrochlorothiazide
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form TABLET, FILM COATED
    Route ORAL
    Active Ingredient Strength 12.5; 150
    Active Ingredient Units mg/1; mg/1
    Substance Name HYDROCHLOROTHIAZIDE; IRBESARTAN
    Labeler Name Bryant Ranch Prepack
    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 ANDA
    Application Number ANDA077369
    Listing Certified Through 2024-12-31

    Package

    NDC 71335-1097-02 (71335109702)

    NDC Package Code 71335-1097-2
    Billing NDC 71335109702
    Package 90 TABLET, FILM COATED in 1 BOTTLE (71335-1097-2)
    Marketing Start Date 2021-03-17
    NDC Exclude Flag N
    Pricing Information N/A