Search by Drug Name or NDC

    NDC 00299-5950-02 TRI-LUMA .1; 40; .5 mg/g; mg/g; mg/g Details

    TRI-LUMA .1; 40; .5 mg/g; mg/g; mg/g

    TRI-LUMA is a TOPICAL CREAM in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Galderma Laboratories, L.P.. The primary component is FLUOCINOLONE ACETONIDE; HYDROQUINONE; TRETINOIN.

    Product Information

    NDC 00299-5950
    Product ID 0299-5950_dcbba72f-e5b7-4688-93b7-d06478f28556
    Associated GPIs 90879903253720
    GCN Sequence Number 049965
    GCN Sequence Number Description fluocinolone/tretinoin/h-quin CREAM (G) 0.01-.05-4 TOPICAL
    HIC3 L9C
    HIC3 Description HYPOPIGMENTATION AGENTS
    GCN 15815
    HICL Sequence Number 023310
    HICL Sequence Number Description FLUOCINOLONE ACETONIDE/TRETINOIN/HYDROQUINONE
    Brand/Generic Brand
    Proprietary Name TRI-LUMA
    Proprietary Name Suffix n/a
    Non-Proprietary Name fluocinolone acetonide, hydroquinone, and tretinoin
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form CREAM
    Route TOPICAL
    Active Ingredient Strength .1; 40; .5
    Active Ingredient Units mg/g; mg/g; mg/g
    Substance Name FLUOCINOLONE ACETONIDE; HYDROQUINONE; TRETINOIN
    Labeler Name Galderma Laboratories, L.P.
    Pharmaceutical Class Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Depigmenting Activity [PE], Melanin Synthesis Inhibitor [EPC], Melanin Synthesis Inhibitors [MoA], Retinoid [EPC], Retinoids [CS]
    DEA Schedule n/a
    Marketing Category NDA
    Application Number NDA021112
    Listing Certified Through 2024-12-31

    Package

    NDC 00299-5950-02 (00299595002)

    NDC Package Code 0299-5950-02
    Billing NDC 00299595002
    Package 1 TUBE in 1 BLISTER PACK (0299-5950-02) / 3 g in 1 TUBE
    Marketing Start Date 2012-04-01
    NDC Exclude Flag N
    Pricing Information N/A