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    NDC 54766-0907-53 BRISDELLE 7.5 mg/1 Details

    BRISDELLE 7.5 mg/1

    BRISDELLE is a ORAL CAPSULE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Sebela Pharmaceuticals Inc.. The primary component is PAROXETINE MESYLATE.

    Product Information

    NDC 54766-0907
    Product ID 54766-907_e190f18a-ef9d-7e9e-e053-2995a90af934
    Associated GPIs 62226060300110
    GCN Sequence Number 071167
    GCN Sequence Number Description paroxetine mesylate CAPSULE 7.5 MG ORAL
    HIC3 G6A
    HIC3 Description MENOPAUSAL SYMPTOMS SUPPRESSANT - SSRIS
    GCN 34876
    HICL Sequence Number 025796
    HICL Sequence Number Description PAROXETINE MESYLATE
    Brand/Generic Brand
    Proprietary Name BRISDELLE
    Proprietary Name Suffix n/a
    Non-Proprietary Name paroxetine
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form CAPSULE
    Route ORAL
    Active Ingredient Strength 7.5
    Active Ingredient Units mg/1
    Substance Name PAROXETINE MESYLATE
    Labeler Name Sebela Pharmaceuticals Inc.
    Pharmaceutical Class Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]
    DEA Schedule n/a
    Marketing Category NDA
    Application Number NDA204516
    Listing Certified Through n/a

    Package

    NDC 54766-0907-53 (54766090753)

    NDC Package Code 54766-907-53
    Billing NDC 54766090753
    Package 30 CAPSULE in 1 BLISTER PACK (54766-907-53)
    Marketing Start Date 2017-05-23
    NDC Exclude Flag N
    Pricing Information N/A