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    NDC 33342-0203-37 Vardenafil 11.85 mg/1 Details

    Vardenafil 11.85 mg/1

    Vardenafil is a ORAL TABLET in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Macleods Pharmaceuticals Limited. The primary component is VARDENAFIL HYDROCHLORIDE TRIHYDRATE.

    Product Information

    NDC 33342-0203
    Product ID 33342-203_0191f1d5-d34e-4185-93dd-3f411aa0e296
    Associated GPIs 40304090107230
    GCN Sequence Number 067179
    GCN Sequence Number Description vardenafil HCl TAB RAPDIS 10 MG ORAL
    HIC3 F2A
    HIC3 Description DRUGS TO TREAT ERECTILE DYSFUNCTION (ED)
    GCN 29673
    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
    Route ORAL
    Active Ingredient Strength 11.85
    Active Ingredient Units mg/1
    Substance Name VARDENAFIL HYDROCHLORIDE TRIHYDRATE
    Labeler Name Macleods Pharmaceuticals Limited
    Pharmaceutical Class Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA205988
    Listing Certified Through 2024-12-31

    Package

    NDC 33342-0203-37 (33342020337)

    NDC Package Code 33342-203-37
    Billing NDC 33342020337
    Package 1 BLISTER PACK in 1 CARTON (33342-203-37) / 4 TABLET in 1 BLISTER PACK
    Marketing Start Date 2018-10-26
    NDC Exclude Flag N
    Pricing Information N/A