Label: LEUKOTRAP - AS-3- as-3 solution

  • NDC Code(s): 53157-460-02
  • Packager: Haemonetics Corporation
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated June 13, 2022

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  • HOW SUPPLIED

    How Supplied: 250 mL CP2D Anticoagulant Solution is supplied in flexible PVC containers with a sterile, non-pyrogenic fluid path. 250 mL and 300 mL AS-3 Nutrient Solution is supplied in flexible PVC containers with a sterile, non-pyrogenic fluid path.

  • PRINCIPAL DISPLAY PANEL

    Principal Display

  • INGREDIENTS AND APPEARANCE
    LEUKOTRAP - AS-3 
    as-3 solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:53157-460
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2) (DEXTROSE, UNSPECIFIED FORM - UNII:IY9XDZ35W2) DEXTROSE, UNSPECIFIED FORM1 g  in 100 mL
    ADENINE (UNII: JAC85A2161) (ADENINE - UNII:JAC85A2161) ADENINE0.03 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53157-460-02250 mL in 1 BAG; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDABN82091510/09/2019
    Labeler - Haemonetics Corporation (057827420)
    Establishment
    NameAddressID/FEIBusiness Operations
    Haemonetics Manufacturing Inc078598396manufacture(53157-460)
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