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    NDC 00299-5980-45 Mirvaso 5 mg/g Details

    Mirvaso 5 mg/g

    Mirvaso is a TOPICAL GEL in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Galderma Laboratories, L.P.. The primary component is BRIMONIDINE TARTRATE.

    Product Information

    NDC 00299-5980
    Product ID 0299-5980_fda53493-1917-4c14-988b-bec8814c37c8
    Associated GPIs 90060020104020
    GCN Sequence Number 071362
    GCN Sequence Number Description brimonidine tartrate GEL (GRAM) 0.33 % TOPICAL
    HIC3 L5G
    HIC3 Description ROSACEA AGENTS, TOPICAL
    GCN 35124
    HICL Sequence Number 011786
    HICL Sequence Number Description BRIMONIDINE TARTRATE
    Brand/Generic Brand
    Proprietary Name Mirvaso
    Proprietary Name Suffix n/a
    Non-Proprietary Name brimonidine tartrate
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form GEL
    Route TOPICAL
    Active Ingredient Strength 5
    Active Ingredient Units mg/g
    Substance Name BRIMONIDINE TARTRATE
    Labeler Name Galderma Laboratories, L.P.
    Pharmaceutical Class Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]
    DEA Schedule n/a
    Marketing Category NDA
    Application Number NDA204708
    Listing Certified Through 2024-12-31

    Package

    NDC 00299-5980-45 (00299598045)

    NDC Package Code 0299-5980-45
    Billing NDC 00299598045
    Package 45 g in 1 TUBE (0299-5980-45)
    Marketing Start Date 2013-08-23
    NDC Exclude Flag N
    Pricing Information N/A