Label: CLOFARABINE injection

  • NDC Code(s): 49315-003-06
  • Packager: Zydus Lifesciences Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated October 18, 2022

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  • SPL UNCLASSIFIED SECTION

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 49315-003-06

    Rx only

    Clofarabine Injection 20 mg/20 mL (1 mg/mL)

    Must Be Diluted Prior To Intravenous Use

    Contains 1 (20 mL) Single-Dose Vial

    Sterile

    Carton label
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 49315-003-06

    Clofarabine Injection 20 mg/20 mL (1 mg/mL)

    Must Be Diluted Prior To Intravenous Use

    Rx only Single-Dose Vial

    vial label
  • INGREDIENTS AND APPEARANCE
    CLOFARABINE 
    clofarabine injection
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:49315-003
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CLOFARABINE (UNII: 762RDY0Y2H) (CLOFARABINE - UNII:762RDY0Y2H) CLOFARABINE1 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM CHLORIDE (UNII: 451W47IQ8X) 9 mg  in 1 mL
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49315-003-061 in 1 CARTON05/10/2017
    120 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20402905/10/2017
    Labeler - Zydus Lifesciences Limited (650348852)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zydus Lifesciences Limited650348852ANALYSIS(49315-003) , MANUFACTURE(49315-003)
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