Label: LYOPHILIZED PEGASPARGASE- pegaspargase injection, powder, lyophilized, for solution

  • NDC Code(s): 0944-3922-01, 0944-3922-02
  • Packager: Baxalta US Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Export only

Drug Label Information

Updated May 3, 2018

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  • PRINCIPAL DISPLAY PANEL - Shipping Label

    Master Label

    Description:

    SHIPPER LABEL Lyophilized Pegaspargase for ____________

    Item Code:

    SL30521XXX 1

    User Group:

    Materials Management

    New [ X ] Revised [ ]

    Reason for Master Label:

    • Per ISS-_______, under CSWO # __________ added new
      shipper label info for Lyophilized Pegaspargase _____________
      to the Weber label database table.
    • Label master template will pull product specific information
      from access database securely from the Weber workstation.

    Weber Archive Name:

    Shipper Label.___

    Created by/Date:

    Approved by/Date:

    1 Shipper Labels are site-created components revised by alpha sequence on the label and Master Label document. In
    SAP the templates are listed by base item code only.

    LYOPHILIZED PEGASPARGASE

    Code: 305-21-

    Exp. Date: F251-0019-01

    Lot #: XXXXX

    U/M: Vial

    Qty: 60

    SL30521

    Exelead, Inc.
    Indianapolis, IN 46268, USA

    999

    Shipping Label
  • INGREDIENTS AND APPEARANCE
    LYOPHILIZED PEGASPARGASE 
    pegaspargase injection, powder, lyophilized, for solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0944-3922
    Route of AdministrationINTRAMUSCULAR
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PEGASPARGASE (UNII: 7D96IR0PPM) (PEGASPARGASE - UNII:7D96IR0PPM) PEGASPARGASE750 U  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE (UNII: 5QWK665956)  
    SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM (UNII: GR686LBA74)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SUCROSE (UNII: C151H8M554)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0944-3922-0260 in 1 CARTON02/07/2018
    1NDC:0944-3922-015 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    EXPORT ONLY02/07/2018
    Labeler - Baxalta US Inc. (079887619)
    Establishment
    NameAddressID/FEIBusiness Operations
    Exelead, Inc961822389MANUFACTURE(0944-3922) , PACK(0944-3922) , LABEL(0944-3922)