Search by Drug Name or NDC

    NDC 71390-0125-50 Barhemsys 2.5 mg/mL Details

    Barhemsys 2.5 mg/mL

    Barhemsys is a INTRAVENOUS INJECTION, SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Acacia Pharma Ltd. The primary component is AMISULPRIDE.

    Product Information

    NDC 71390-0125
    Product ID 71390-125_3aa09356-e93c-40c1-bb84-547ac93f1388
    Associated GPIs 50100010002020 50100010002025
    GCN Sequence Number 080792
    GCN Sequence Number Description amisulpride VIAL 5 MG/2 ML INTRAVEN
    HIC3 H6J
    HIC3 Description ANTIEMETIC/ANTIVERTIGO AGENTS
    GCN 47767
    HICL Sequence Number 010728
    HICL Sequence Number Description AMISULPRIDE
    Brand/Generic Brand
    Proprietary Name Barhemsys
    Proprietary Name Suffix n/a
    Non-Proprietary Name Amisulpride
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form INJECTION, SOLUTION
    Route INTRAVENOUS
    Active Ingredient Strength 2.5
    Active Ingredient Units mg/mL
    Substance Name AMISULPRIDE
    Labeler Name Acacia Pharma Ltd
    Pharmaceutical Class Dopamine D2 Antagonists [MoA], Dopamine-2 Receptor Antagonist [EPC]
    DEA Schedule n/a
    Marketing Category NDA
    Application Number NDA209510
    Listing Certified Through 2024-12-31

    Package

    NDC 71390-0125-50 (71390012550)

    NDC Package Code 71390-125-50
    Billing NDC 71390012550
    Package 10 CARTON in 1 PACKAGE (71390-125-50) / 1 VIAL, SINGLE-DOSE in 1 CARTON (71390-125-51) / 4 mL in 1 VIAL, SINGLE-DOSE
    Marketing Start Date 2020-02-27
    NDC Exclude Flag N
    Pricing Information N/A

    Standard Product Labeling (SPL)/Prescribing Information SPL ab23bc6e-b6a8-165f-e053-2a95a90ab144 Details

    Revised: 9/2022