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    NDC 65862-0638-05 Irbesartan 150 mg/1 Details

    Irbesartan 150 mg/1

    Irbesartan is a ORAL TABLET in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Aurobindo Pharma Limited. The primary component is IRBESARTAN.

    Product Information

    NDC 65862-0638
    Product ID 65862-638_388aa520-efb3-4265-b43b-eeaec16b952b
    Associated GPIs 36150030000320
    GCN Sequence Number 034468
    GCN Sequence Number Description irbesartan TABLET 150 MG ORAL
    HIC3 A4F
    HIC3 Description ANTIHYPERTENSIVES, ANGIOTENSIN RECEPTOR ANTAGONIST
    GCN 04749
    HICL Sequence Number 015576
    HICL Sequence Number Description IRBESARTAN
    Brand/Generic Generic
    Proprietary Name Irbesartan
    Proprietary Name Suffix n/a
    Non-Proprietary Name Irbesartan
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form TABLET
    Route ORAL
    Active Ingredient Strength 150
    Active Ingredient Units mg/1
    Substance Name IRBESARTAN
    Labeler Name Aurobindo Pharma Limited
    Pharmaceutical Class Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA203081
    Listing Certified Through 2024-12-31

    Package

    NDC 65862-0638-05 (65862063805)

    NDC Package Code 65862-638-05
    Billing NDC 65862063805
    Package 500 TABLET in 1 BOTTLE (65862-638-05)
    Marketing Start Date 2012-09-27
    NDC Exclude Flag N
    Pricing Information N/A

    Standard Product Labeling (SPL)/Prescribing Information SPL 2113a901-2612-4557-b86d-3afc006fb8bb Details

    Revised: 9/2021