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    NDC 54092-0519-02 Intuniv 4 mg/1 Details

    Intuniv 4 mg/1

    Intuniv is a ORAL TABLET, EXTENDED RELEASE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Takeda Pharmaceuticals America, Inc.. The primary component is GUANFACINE HYDROCHLORIDE.

    Product Information

    NDC 54092-0519
    Product ID 54092-519_1eef54c1-5c87-44f1-bab6-42f72d4fe0be
    Associated GPIs 61353030107550
    GCN Sequence Number 065574
    GCN Sequence Number Description guanfacine HCl TAB ER 24H 4 MG ORAL
    HIC3 H8M
    HIC3 Description TX FOR ADHD - SELECTIVE ALPHA-2 RECEPTOR AGONIST
    GCN 27582
    HICL Sequence Number 000120
    HICL Sequence Number Description GUANFACINE HCL
    Brand/Generic Brand
    Proprietary Name Intuniv
    Proprietary Name Suffix n/a
    Non-Proprietary Name guanfacine
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form TABLET, EXTENDED RELEASE
    Route ORAL
    Active Ingredient Strength 4
    Active Ingredient Units mg/1
    Substance Name GUANFACINE HYDROCHLORIDE
    Labeler Name Takeda Pharmaceuticals America, Inc.
    Pharmaceutical Class Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]
    DEA Schedule n/a
    Marketing Category NDA
    Application Number NDA022037
    Listing Certified Through 2024-12-31

    Package

    NDC 54092-0519-02 (54092051902)

    NDC Package Code 54092-519-02
    Billing NDC 54092051902
    Package 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (54092-519-02)
    Marketing Start Date 2009-09-02
    NDC Exclude Flag N
    Pricing Information N/A