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    NDC 76420-0126-90 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 Asclemed USA, Inc.. The primary component is TADALAFIL.

    Product Information

    NDC 76420-0126
    Product ID 76420-126_d6b1a441-d2cb-e481-e053-2995a90abf78
    Associated GPIs
    GCN Sequence Number n/a
    GCN Sequence Number Description n/a
    HIC3 n/a
    HIC3 Description n/a
    GCN n/a
    HICL Sequence Number n/a
    HICL Sequence Number Description n/a
    Brand/Generic n/a
    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 Asclemed USA, Inc.
    Pharmaceutical Class Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA209167
    Listing Certified Through 2024-12-31

    Package

    NDC 76420-0126-90 (76420012690)

    NDC Package Code 76420-126-90
    Billing NDC 76420012690
    Package 90 TABLET, FILM COATED in 1 BOTTLE (76420-126-90)
    Marketing Start Date 2020-07-30
    NDC Exclude Flag N
    Pricing Information N/A

    Standard Product Labeling (SPL)/Prescribing Information SPL aba646fe-70c2-1abb-e053-2995a90aa16d Details

    Revised: 1/2022