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    NDC 00362-1095-60 Lignospan Standard .01; 20 mg/mL; mg/mL Details

    Lignospan Standard .01; 20 mg/mL; mg/mL

    Lignospan Standard is a SUBCUTANEOUS INJECTION, SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Septodont, Inc.. The primary component is EPINEPHRINE BITARTRATE; LIDOCAINE HYDROCHLORIDE.

    Product Information

    NDC 00362-1095
    Product ID 0362-1095_68ef2658-de42-40f3-9c29-1640585200da
    Associated GPIs
    GCN Sequence Number 050239
    GCN Sequence Number Description lidocaine HCl/epinephrine bit CARTRIDGE 2 %-1:100K INJECTION
    HIC3 H0A
    HIC3 Description LOCAL ANESTHETICS
    GCN 17215
    HICL Sequence Number 013748
    HICL Sequence Number Description LIDOCAINE HCL/EPINEPHRINE BITARTRATE
    Brand/Generic Generic
    Proprietary Name Lignospan Standard
    Proprietary Name Suffix n/a
    Non-Proprietary Name Lidocaine Hydrochloride and Epinephrine
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form INJECTION, SOLUTION
    Route SUBCUTANEOUS
    Active Ingredient Strength .01; 20
    Active Ingredient Units mg/mL; mg/mL
    Substance Name EPINEPHRINE BITARTRATE; LIDOCAINE HYDROCHLORIDE
    Labeler Name Septodont, Inc.
    Pharmaceutical Class Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Catecholamine [EPC], Catecholamines [CS], Local Anesthesia [PE], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA088390
    Listing Certified Through 2024-12-31

    Package

    NDC 00362-1095-60 (00362109560)

    NDC Package Code 0362-1095-60
    Billing NDC 00362109560
    Package 5 BLISTER PACK in 1 CARTON (0362-1095-60) / 10 CARTRIDGE in 1 BLISTER PACK / 1.7 mL in 1 CARTRIDGE
    Marketing Start Date 2017-11-28
    NDC Exclude Flag N
    Pricing Information N/A

    Standard Product Labeling (SPL)/Prescribing Information SPL f902d2b4-28fc-41b1-a9f7-0d1a63c598aa Details

    Revised: 8/2022