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    NDC 42808-0204-28 Urea 450 mg/mL Details

    Urea 450 mg/mL

    Urea is a TOPICAL GEL in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Exact-Rx, Inc.. The primary component is UREA.

    Product Information

    NDC 42808-0204
    Product ID 42808-204_086b2d75-beb1-4856-e063-6294a90ad02e
    Associated GPIs 90660080004045
    GCN Sequence Number 064590
    GCN Sequence Number Description urea GEL (ML) 45 % TOPICAL
    HIC3 L5A
    HIC3 Description KERATOLYTICS
    GCN 15557
    HICL Sequence Number 002716
    HICL Sequence Number Description UREA
    Brand/Generic Generic
    Proprietary Name Urea
    Proprietary Name Suffix n/a
    Non-Proprietary Name Urea
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form GEL
    Route TOPICAL
    Active Ingredient Strength 450
    Active Ingredient Units mg/mL
    Substance Name UREA
    Labeler Name Exact-Rx, Inc.
    Pharmaceutical Class n/a
    DEA Schedule n/a
    Marketing Category UNAPPROVED DRUG OTHER
    Application Number n/a
    Listing Certified Through 2024-12-31

    Package

    NDC 42808-0204-28 (42808020428)

    NDC Package Code 42808-204-28
    Billing NDC 42808020428
    Package 1 BOTTLE, GLASS in 1 CARTON (42808-204-28) / 28 mL in 1 BOTTLE, GLASS
    Marketing Start Date 2011-08-01
    NDC Exclude Flag N
    Pricing Information N/A