Label: HALAVEN- eribulin mesylate injection

  • NDC Code(s): 43624-002-01
  • Packager: BSP Pharmaceuticals SpA
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated December 14, 2020

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  • Halaven®

    (eribulin mesylate) Injection, for intravenous use
    1 mg/2 mL (0.5 mg/mL)

  • PRINCIPAL DISPLAY PANEL - SHIPPER LABEL

    Eisai Manufacturing Limited                

    ​Allegato DQA-035/XXXX​

    New Chemical Entity Demand Chain Unit European Knowledge Centre

    Mosquito Way-Hatfield, Herts, AL 109SN

    United Kingdom

    ​​HALAVEN®
    (eribulin mesylate) Injection, for intravenous use- 0.5mg/ml, 2 ml
    Store at 15° - 25°C (59° - 77°F). DO NOT FREEZE

    QTY: 00XXX EXP: MM-YYYY LOT: F1XXYZZZ
     (22) 900XXX MMYYYY F1XXYZZZ 7

    NDC 43624-002-01

    (0X) 50X XXXXX 00X X X0 XXX

    Manufactured by : BSP Pharmaceuticals SpA-Latina Scalo, Italy.

    Image (eribulin mesylate) Injection1 mg/2 mL(0.5 mg/mL)For Intravenous Use

  • INGREDIENTS AND APPEARANCE
    HALAVEN 
    eribulin mesylate injection
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:43624-002
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ERIBULIN MESYLATE (UNII: AV9U0660CW) (ERIBULIN - UNII:LR24G6354G) ERIBULIN MESYLATE0.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Colorwhite (clear, colorless, sterile solution for intravenous administration) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43624-002-01100 in 1 BOX, UNIT-DOSE04/21/2017
    13 mL in 1 TRAY; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA20153204/21/2017
    Labeler - BSP Pharmaceuticals SpA (857007830)
    Registrant - BSP Pharmaceuticals SpA (857007830)
    Establishment
    NameAddressID/FEIBusiness Operations
    BSP Pharmaceuticals SpA857007830manufacture(43624-002)