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    NDC 45146-0120-02 Orabloc 40; 5 mg/mL; ug/mL Details

    Orabloc 40; 5 mg/mL; ug/mL

    Orabloc is a SUBMUCOSAL INJECTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Pierrel S.p.A.. The primary component is ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE.

    Product Information

    NDC 45146-0120
    Product ID 45146-120_df09bf36-46b3-4edf-9a11-9d12bb7e12b3
    Associated GPIs
    GCN Sequence Number n/a
    GCN Sequence Number Description n/a
    HIC3 n/a
    HIC3 Description n/a
    GCN n/a
    HICL Sequence Number n/a
    HICL Sequence Number Description n/a
    Brand/Generic n/a
    Proprietary Name Orabloc
    Proprietary Name Suffix n/a
    Non-Proprietary Name articaine hydrochloride and epinephrine bitartrate
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form INJECTION
    Route SUBMUCOSAL
    Active Ingredient Strength 40; 5
    Active Ingredient Units mg/mL; ug/mL
    Substance Name ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE
    Labeler Name Pierrel S.p.A.
    Pharmaceutical Class Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Amide Local Anesthetic [EPC], Amides [CS], Catecholamine [EPC], Catecholamines [CS], Local Anesthesia [PE], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]
    DEA Schedule n/a
    Marketing Category NDA
    Application Number NDA022466
    Listing Certified Through 2024-12-31

    Package

    NDC 45146-0120-02 (45146012002)

    NDC Package Code 45146-120-02
    Billing NDC 45146012002
    Package 50 CARTRIDGE in 1 BOX (45146-120-02) / 1.8 mL in 1 CARTRIDGE
    Marketing Start Date 2011-03-01
    NDC Exclude Flag N
    Pricing Information N/A

    Standard Product Labeling (SPL)/Prescribing Information SPL d18424f0-a691-11dd-ad8b-0800200c9a66 Details

    Revised: 11/2018