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    NDC 70710-1069-09 VARDENAFIL 5 mg/1 Details

    VARDENAFIL 5 mg/1

    VARDENAFIL 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 VARDENAFIL HYDROCHLORIDE TRIHYDRATE.

    Product Information

    NDC 70710-1069
    Product ID 70710-1069_e97a1af7-d019-47d4-85f4-7bcd58fc0389
    Associated GPIs 40304090100320
    GCN Sequence Number 051882
    GCN Sequence Number Description vardenafil HCl TABLET 5 MG ORAL
    HIC3 F2A
    HIC3 Description DRUGS TO TREAT ERECTILE DYSFUNCTION (ED)
    GCN 19326
    HICL Sequence Number 025035
    HICL Sequence Number Description VARDENAFIL HCL
    Brand/Generic Generic
    Proprietary Name VARDENAFIL
    Proprietary Name Suffix n/a
    Non-Proprietary Name VARDENAFIL
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form TABLET, FILM COATED
    Route ORAL
    Active Ingredient Strength 5
    Active Ingredient Units mg/1
    Substance Name VARDENAFIL HYDROCHLORIDE TRIHYDRATE
    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 ANDA208960
    Listing Certified Through 2024-12-31

    Package

    NDC 70710-1069-09 (70710106909)

    NDC Package Code 70710-1069-9
    Billing NDC 70710106909
    Package 90 TABLET, FILM COATED in 1 BOTTLE (70710-1069-9)
    Marketing Start Date 2018-11-01
    NDC Exclude Flag N
    Pricing Information N/A