Label: NELARABINE injection

  • NDC Code(s): 70771-1685-1, 70771-1685-8
  • Packager: Zydus Lifesciences Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated November 5, 2022

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  • SPL UNCLASSIFIED SECTION

    .

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 70771-1685-1

    Nelarabine Injection 250 mg/5 mL (5 mg/mL)

    50 mL Single-Dose Vial

    For Intravenous Infusion Only

    Rx Only

    vial label

    NDC 70771-1685-1

    Nelarabine Injection 250 mg/5 mL (5 mg/mL)

    50 mL Single-Dose Vial Carton

    For Intravenous Infusion Only

    Rx Only

  • INGREDIENTS AND APPEARANCE
    NELARABINE 
    nelarabine injection
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1685
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NELARABINE (UNII: 60158CV180) (NELARABINE - UNII:60158CV180) NELARABINE5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1685-11 in 1 CARTON11/17/2021
    150 mL in 1 VIAL; Type 0: Not a Combination Product
    2NDC:70771-1685-86 in 1 CARTON11/17/2021
    250 mL in 1 VIAL; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21503711/17/2021
    Labeler - Zydus Lifesciences Limited (918596198)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zydus Lifesciences Limited650348852ANALYSIS(70771-1685) , MANUFACTURE(70771-1685)
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