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    NDC 70954-0168-10 Sildenafil 10 mg/mL Details

    Sildenafil 10 mg/mL

    Sildenafil is a ORAL FOR SUSPENSION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by ANI Pharmaceuticals, Inc.. The primary component is SILDENAFIL CITRATE.

    Product Information

    NDC 70954-0168
    Product ID 70954-168_38afc2b0-7d38-4f51-8c70-fd553855e624
    Associated GPIs 40143060101920
    GCN Sequence Number 069921
    GCN Sequence Number Description sildenafil citrate SUSP RECON 10 MG/ML ORAL
    HIC3 B1D
    HIC3 Description PULM.ANTI-HTN,SEL.C-GMP PHOSPHODIESTERASE T5 INHIB
    GCN 33186
    HICL Sequence Number 018084
    HICL Sequence Number Description SILDENAFIL CITRATE
    Brand/Generic Generic
    Proprietary Name Sildenafil
    Proprietary Name Suffix n/a
    Non-Proprietary Name Sildenafil citrate
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form FOR SUSPENSION
    Route ORAL
    Active Ingredient Strength 10
    Active Ingredient Units mg/mL
    Substance Name SILDENAFIL CITRATE
    Labeler Name ANI Pharmaceuticals, Inc.
    Pharmaceutical Class Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA212260
    Listing Certified Through 2024-12-31

    Package

    NDC 70954-0168-10 (70954016810)

    NDC Package Code 70954-168-10
    Billing NDC 70954016810
    Package 1 BOTTLE in 1 CARTON (70954-168-10) / 112 mL in 1 BOTTLE
    Marketing Start Date 2019-05-31
    NDC Exclude Flag N
    Pricing Information N/A