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    NDC 16110-0526-30 Aczone 75 mg/g Details

    Aczone 75 mg/g

    Aczone is a TOPICAL GEL in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Almirall, LLC. The primary component is DAPSONE.

    Product Information

    NDC 16110-0526
    Product ID 16110-526_d5de2546-ff51-4370-bb6f-8995a47fe7b4
    Associated GPIs 90051015004030
    GCN Sequence Number 075635
    GCN Sequence Number Description dapsone GEL W/PUMP 7.5 % TOPICAL
    HIC3 L5H
    HIC3 Description ACNE AGENTS,TOPICAL
    GCN 37634
    HICL Sequence Number 004177
    HICL Sequence Number Description DAPSONE
    Brand/Generic Brand
    Proprietary Name Aczone
    Proprietary Name Suffix n/a
    Non-Proprietary Name dapsone
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form GEL
    Route TOPICAL
    Active Ingredient Strength 75
    Active Ingredient Units mg/g
    Substance Name DAPSONE
    Labeler Name Almirall, LLC
    Pharmaceutical Class Sulfone [EPC], Sulfones [CS]
    DEA Schedule n/a
    Marketing Category NDA
    Application Number NDA207154
    Listing Certified Through 2024-12-31

    Package

    NDC 16110-0526-30 (16110052630)

    NDC Package Code 16110-526-30
    Billing NDC 16110052630
    Package 1 BOTTLE, PUMP in 1 CARTON (16110-526-30) / 30 g in 1 BOTTLE, PUMP
    Marketing Start Date 2019-09-10
    NDC Exclude Flag N
    Pricing Information N/A