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    NDC 71335-1154-02 BUPRENORPHINE 8 mg/1 Details

    BUPRENORPHINE 8 mg/1

    BUPRENORPHINE is a SUBLINGUAL TABLET in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Bryant Ranch Prepack. The primary component is BUPRENORPHINE HYDROCHLORIDE.

    Product Information

    NDC 71335-1154
    Product ID 71335-1154_29f77e5d-60c5-4355-9083-bf7704ff8735
    Associated GPIs 65200010100780
    GCN Sequence Number 029313
    GCN Sequence Number Description buprenorphine HCl TAB SUBL 8 MG SUBLINGUAL
    HIC3 H3W
    HIC3 Description OPIOID WITHDRAWAL THERAPY AGENTS, OPIOID-TYPE
    GCN 64673
    HICL Sequence Number 001762
    HICL Sequence Number Description BUPRENORPHINE HCL
    Brand/Generic Generic
    Proprietary Name BUPRENORPHINE
    Proprietary Name Suffix n/a
    Non-Proprietary Name BUPRENORPHINE
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form TABLET
    Route SUBLINGUAL
    Active Ingredient Strength 8
    Active Ingredient Units mg/1
    Substance Name BUPRENORPHINE HYDROCHLORIDE
    Labeler Name Bryant Ranch Prepack
    Pharmaceutical Class Partial Opioid Agonist [EPC], Partial Opioid Agonists [MoA]
    DEA Schedule CIII
    Marketing Category ANDA
    Application Number ANDA207276
    Listing Certified Through 2024-12-31

    Package

    NDC 71335-1154-02 (71335115402)

    NDC Package Code 71335-1154-2
    Billing NDC 71335115402
    Package 60 TABLET in 1 BOTTLE (71335-1154-2)
    Marketing Start Date 2019-03-15
    NDC Exclude Flag N
    Pricing Information N/A