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    NDC 51672-2143-06 Adapalene 1 mg/g Details

    Adapalene 1 mg/g

    Adapalene is a TOPICAL GEL in the HUMAN OTC DRUG category. It is labeled and distributed by Taro Pharmaceuticals U.S.A., Inc.. The primary component is ADAPALENE.

    Product Information

    NDC 51672-2143
    Product ID 51672-2143_740cf78a-9728-4245-9ca2-448d2c9a997d
    Associated GPIs
    GCN Sequence Number 026436
    GCN Sequence Number Description adapalene GEL (GRAM) 0.1 % TOPICAL
    HIC3 L9B
    HIC3 Description VITAMIN A DERIVATIVES
    GCN 29300
    HICL Sequence Number 011233
    HICL Sequence Number Description ADAPALENE
    Brand/Generic Generic
    Proprietary Name Adapalene
    Proprietary Name Suffix n/a
    Non-Proprietary Name Adapalene
    Product Type HUMAN OTC DRUG
    Dosage Form GEL
    Route TOPICAL
    Active Ingredient Strength 1
    Active Ingredient Units mg/g
    Substance Name ADAPALENE
    Labeler Name Taro Pharmaceuticals U.S.A., Inc.
    Pharmaceutical Class Retinoid [EPC], Retinoids [CS]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA215940
    Listing Certified Through 2023-12-31

    Package

    NDC 51672-2143-06 (51672214306)

    NDC Package Code 51672-2143-6
    Billing NDC 51672214306
    Package 1 TUBE in 1 CARTON (51672-2143-6) / 45 g in 1 TUBE
    Marketing Start Date 2022-01-14
    NDC Exclude Flag N
    Pricing Information N/A

    Standard Product Labeling (SPL)/Prescribing Information SPL a9ca1f7a-71c3-4814-9366-e7e5760bf32c Details

    Revised: 1/2022