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    NDC 71335-1858-01 BUPRENORPHINE HYDROCHLORIDE and NALOXONE HYDROCHLORIDE DIHYDRATE 8; 2 mg/1; mg/1 Details

    BUPRENORPHINE HYDROCHLORIDE and NALOXONE HYDROCHLORIDE DIHYDRATE 8; 2 mg/1; mg/1

    BUPRENORPHINE HYDROCHLORIDE and NALOXONE HYDROCHLORIDE DIHYDRATE 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; NALOXONE HYDROCHLORIDE DIHYDRATE.

    Product Information

    NDC 71335-1858
    Product ID 71335-1858_9bc52e26-1d52-4d68-894a-d3b300f5f090
    Associated GPIs 65200010200740
    GCN Sequence Number 051641
    GCN Sequence Number Description buprenorphine HCl/naloxone HCl TAB SUBL 8 MG-2 MG SUBLINGUAL
    HIC3 H3W
    HIC3 Description OPIOID WITHDRAWAL THERAPY AGENTS, OPIOID-TYPE
    GCN 18974
    HICL Sequence Number 024846
    HICL Sequence Number Description BUPRENORPHINE HCL/NALOXONE HCL
    Brand/Generic Generic
    Proprietary Name BUPRENORPHINE HYDROCHLORIDE and NALOXONE HYDROCHLORIDE DIHYDRATE
    Proprietary Name Suffix n/a
    Non-Proprietary Name BUPRENORPHINE HYDROCHLORIDE and NALOXONE HYDROCHLORIDE DIHYDRATE
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form TABLET
    Route SUBLINGUAL
    Active Ingredient Strength 8; 2
    Active Ingredient Units mg/1; mg/1
    Substance Name BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE DIHYDRATE
    Labeler Name Bryant Ranch Prepack
    Pharmaceutical Class Opioid Antagonist [EPC], Opioid Antagonists [MoA], Partial Opioid Agonist [EPC], Partial Opioid Agonists [MoA]
    DEA Schedule CIII
    Marketing Category ANDA
    Application Number ANDA209069
    Listing Certified Through 2024-12-31

    Package

    NDC 71335-1858-01 (71335185801)

    NDC Package Code 71335-1858-1
    Billing NDC 71335185801
    Package 30 TABLET in 1 BOTTLE, PLASTIC (71335-1858-1)
    Marketing Start Date 2021-05-07
    NDC Exclude Flag N
    Pricing Information N/A