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    NDC 68382-0897-05 Tadalafil 5 mg/1 Details

    Tadalafil 5 mg/1

    Tadalafil is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Zydus Pharmaceuticals USA Inc.. The primary component is TADALAFIL.

    Product Information

    NDC 68382-0897
    Product ID 68382-897_5a958db7-5c0e-4cf0-9227-230886cf9bf8
    Associated GPIs 40304080000305
    GCN Sequence Number 053296
    GCN Sequence Number Description tadalafil TABLET 5 MG ORAL
    HIC3 F2A
    HIC3 Description DRUGS TO TREAT ERECTILE DYSFUNCTION (ED)
    GCN 20736
    HICL Sequence Number 024859
    HICL Sequence Number Description TADALAFIL
    Brand/Generic Generic
    Proprietary Name Tadalafil
    Proprietary Name Suffix n/a
    Non-Proprietary Name Tadalafil
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form TABLET, FILM COATED
    Route ORAL
    Active Ingredient Strength 5
    Active Ingredient Units mg/1
    Substance Name TADALAFIL
    Labeler Name Zydus Pharmaceuticals USA Inc.
    Pharmaceutical Class Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA206693
    Listing Certified Through 2024-12-31

    Package

    NDC 68382-0897-05 (68382089705)

    NDC Package Code 68382-897-05
    Billing NDC 68382089705
    Package 500 TABLET, FILM COATED in 1 BOTTLE (68382-897-05)
    Marketing Start Date 2019-03-27
    NDC Exclude Flag N
    Pricing Information N/A