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

  • NDC Code(s): 72694-313-01
  • Packager: Servier Pharmaceuticals
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Export only

Drug Label Information

Updated August 3, 2020

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  • PRINCIPAL DISPLAY PANEL - Shipping Label

    Manufactured By:
    Exelead, Inc.
    Indianapolis, IN 46268, USA
    Distributed By:
    Les Laboratoires Servier
    92284 Suresnes, France
    Store Between 2°C and 8°C (36°F to 46°F)
    Do not freeze

    Lyophilized Pegaspargase (750 U/mL) Export Only
    U/M:Vial
    Code:305-21-AR
    PC 07795384010495

    EXP: 07 2025

    LOT: 1234F

    Pallet

    PLS-305-21-AR-B

    Manufactured By: Exelead, Inc.
    Indianapolis, IN 46268, USA
    Distributed By: Les Laboratoires Servier
    92284 Suresnes, France
    Store Between 2°C and 8°C (36°F to 46°F)
    Do not freeze
    Lyophilized Pegaspargase (750 U/mL) Export Only
    U/M:Vial
    Code:305-21-AR
    PC 07795384010495

    EXP: 07 2025
    LOT: 1234F
    QTY: 60

    Case

    ALS-305-21-AR-B

    PRINCIPAL DISPLAY PANEL - Shipping Label
  • INGREDIENTS AND APPEARANCE
    LYOPHILIZED PEGASPARGASE 
    pegaspargase injection, powder, lyophilized, for solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:72694-313
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PEGASPARGASE (UNII: 7D96IR0PPM) (PEGASPARGASE - UNII:7D96IR0PPM) PEGASPARGASE750 [iU]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM (UNII: GR686LBA74)  
    SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE (UNII: 5QWK665956)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SUCROSE (UNII: C151H8M554)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72694-313-011 in 1 CARTON08/03/2020
    15 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 ONLY08/03/2020
    Labeler - Servier Pharmaceuticals (116608503)