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    NDC 62332-0053-91 Irbesartan and Hydrochlorothiazide 25; 300 mg/1; mg/1 Details

    Irbesartan and Hydrochlorothiazide 25; 300 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 Alembic Pharmaceuticals Inc.. The primary component is HYDROCHLOROTHIAZIDE; IRBESARTAN.

    Product Information

    NDC 62332-0053
    Product ID 62332-053_a749e5f3-f0e7-41db-a3c6-ff6928d7f51f
    Associated GPIs
    GCN Sequence Number n/a
    GCN Sequence Number Description n/a
    HIC3 n/a
    HIC3 Description n/a
    GCN n/a
    HICL Sequence Number n/a
    HICL Sequence Number Description n/a
    Brand/Generic n/a
    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 25; 300
    Active Ingredient Units mg/1; mg/1
    Substance Name HYDROCHLOROTHIAZIDE; IRBESARTAN
    Labeler Name Alembic Pharmaceuticals Inc.
    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 ANDA091370
    Listing Certified Through 2024-12-31

    Package

    NDC 62332-0053-91 (62332005391)

    NDC Package Code 62332-053-91
    Billing NDC 62332005391
    Package 1000 TABLET, FILM COATED in 1 BOTTLE (62332-053-91)
    Marketing Start Date 2016-05-23
    NDC Exclude Flag N
    Pricing Information N/A