Label: SODIUM CITRATE BLOOD-PACK UNITS, (PL 146 PLASTIC)- anticoagulant sodium citrate solution solution

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated February 11, 2022

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  • Anticoagulant Sodium Citrate Solution USP

    A standalone direction insert does not exist for this product.

  • PACKAGE/LABEL DISPLAY PANEL

    CAUTION–DO NOT REMOVE UNIT FROM OVERWRAP UNTIL READY FOR USE
    THE OVERWRAP IS A MOISTURE BARRIER
    THE INNER BAG MAINTAINS STERILITY OF THE PRODUCT
    STORE AT CONTROLLED ROOM TEMPERATURE.

    CODE 4B7889Q

    NDC 0942-9504-10

    500 mL

    Fenwal™

    Anticoagulant Sodium Citrate Solution USP

    Rx only

    EACH 100 mL CONTAINS 4 g SODIUM CITRATE (DIHYDRATE) USP
    pH ADJUSTED WITH CITRIC ACID

    STERILE
    NONPYROGENIC

    FOR USE WITH CYTAPHERESIS DEVICE ONLY

    NOT FOR DIRECT INTRAVENOUS INFUSION

    SINGLE USE CONTAINER
    DISCARD UNUSED PORTION

    DO NOT USE UNLESS SOLUTION IS CLEAR AND NO LEAKS ARE DETECTED

    AFTER REMOVING OVERWRAP CHECK FOR MINUTE LEAKS BY SQUEEZING INNER BAG FIRMLY
    IF LEAKS ARE FOUND DISCARD SOLUTION AS STERILITY MAY BE IMPAIRED

    MANUFACTURED BY:
    BAXTER HEALTHCARE CORPORATION
    DEERFIELD, IL 60015 USA

    MANUFACTURED FOR:

    FENWAL, INC.
    LAKE ZURICH, IL 60047 USA

    MADE IN USA
    07-25-58-000

    PL 146 PLASTIC

    Anticoagulant Sodium Citrate Solution USP label
  • INGREDIENTS AND APPEARANCE
    SODIUM CITRATE BLOOD-PACK UNITS, (PL 146 PLASTIC) 
    anticoagulant sodium citrate solution solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0942-9504
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K) (Anhydrous Citric Acid - UNII:XF417D3PSL) Anhydrous Citric Acid4 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0942-9504-10500 mL in 1 BAG; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDABN77092303/01/2007
    Labeler - Fenwal, Inc. (794519020)
    Registrant - Fenwal, Inc. (794519020)
    Establishment
    NameAddressID/FEIBusiness Operations
    Baxter Healthcare Corporation059140764MANUFACTURE(0942-9504)
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