Label: LACOSAMIDE injection

  • NDC Code(s): 70771-1682-1, 70771-1682-6
  • Packager: Zydus Lifesciences Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: CV
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated October 3, 2023

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  • SPL UNCLASSIFIED SECTION

  • SPL MEDGUIDE

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 70771-1682-1

    Lacosamide Injection, USP 200 mg/20 mL (10 mg/mL); CV

    For Intravenous Use Only

    20 mL single-dose vial

    Rx only

    vial label

    NDC 70771-1682-6

    Lacosamide Injection, USP 200 mg/20 mL (10 mg/mL); CV

    For Intravenous Use Only

    10 X 20 mL Single-dose vials

    Rx only

    carton label
  • INGREDIENTS AND APPEARANCE
    LACOSAMIDE 
    lacosamide injection
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1682
    Route of AdministrationINTRAVENOUSDEA ScheduleCV    
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LACOSAMIDE (UNII: 563KS2PQY5) (LACOSAMIDE - UNII:563KS2PQY5) LACOSAMIDE10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1682-610 in 1 CARTON06/29/2022
    1NDC:70771-1682-120 mL in 1 VIAL; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20946506/29/2022
    Labeler - Zydus Lifesciences Limited (918596198)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zydus Lifesciences Limited873671928MANUFACTURE(70771-1682) , ANALYSIS(70771-1682)
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