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    NDC 68382-0473-05 telmisartan 80 mg/1 Details

    telmisartan 80 mg/1

    telmisartan is a ORAL TABLET in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Zydus Pharmaceuticals USA Inc.. The primary component is TELMISARTAN.

    Product Information

    NDC 68382-0473
    Product ID 68382-473_99f660d2-4407-490e-a79f-6523bece714d
    Associated GPIs 36150070000340
    GCN Sequence Number 040911
    GCN Sequence Number Description telmisartan TABLET 80 MG ORAL
    HIC3 A4F
    HIC3 Description ANTIHYPERTENSIVES, ANGIOTENSIN RECEPTOR ANTAGONIST
    GCN 23832
    HICL Sequence Number 018839
    HICL Sequence Number Description TELMISARTAN
    Brand/Generic Generic
    Proprietary Name telmisartan
    Proprietary Name Suffix n/a
    Non-Proprietary Name telmisartan
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form TABLET
    Route ORAL
    Active Ingredient Strength 80
    Active Ingredient Units mg/1
    Substance Name TELMISARTAN
    Labeler Name Zydus Pharmaceuticals USA Inc.
    Pharmaceutical Class Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA203325
    Listing Certified Through 2024-12-31

    Package

    NDC 68382-0473-05 (68382047305)

    NDC Package Code 68382-473-05
    Billing NDC 68382047305
    Package 500 TABLET in 1 BOTTLE (68382-473-05)
    Marketing Start Date 2014-08-27
    NDC Exclude Flag N
    Pricing Information N/A