Label: ANTICOAGULANT SODIUM CITRATE- trisodium citrate dihydrate solution

  • NDC Code(s): 0338-9669-01
  • Packager: Baxter Healthcare Corporation
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated July 1, 2024

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  • INDICATIONS AND USAGE

    Anticoagulant Sodium Citrate 4% w/v Solution, USP is intended for use only with automated apheresis devices.

  • ADMINISTRATION

    The pouch is a moisture barrier. Do not remove from pouch until ready to use. Do not use unless solution is clear and no leaks detected. Do not use unless port protector is in place.

  • DOSAGE FORMS AND STRENGTHS

    Anticoagulant Sodium Citrate 4% w/v Solution, USP in the 250 mL single dose container is a sterile solution that contains 4g Sodium Citrate Dihydrate, USP per 100 mL, pH adjusted with citric acid.

  • PRECAUTIONS

    Not for direct intravenous infusion.

  • HOW SUPPLIED

    Anticoagulant Sodium Citrate 4% w/v Solution, USP is a clear solution supplied in sterile and nonpyrogenic PVC bags per carton.

    Storage and Handling

    Store at room temperature (25C/77F). Avoid excessive heat. Protect from freezing.

  • PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

    Carton Label

    LOT

    EXP

    2B7867
    NDC 0338-9669-01

    Anticoagulant
    Sodium Citrate
    4% w/v
    Solution USP

    Rx only

    250 mL EACH 100 mL CONTAINS 4 g SODIUM
    CITRATE (DIHYDRATE) USP
    pH ADJUSTED WITH CITRIC ACID
    STERILE NONPYROGENIC
    INTENDED FOR USE ONLY WITH AUTOMATED APHERESIS
    DEVICES
    CAUTION — NOT FOR DIRECT INTRAVENOUS INFUSION THE
    POUCH IS A MOISTURE BARRIER DO NOT USE UNLESS
    SOLUTION IS CLEAR SQUEEZE AND INSPECT INNER BAG
    WHICH MAINTAINS PRODUCT STERILITY DISCARD IF LEAKS
    ARE FOUND SINGLE USE CONTAINER DISCARD UNUSED
    PORTION DIRECTIONS FOR USE ARE CONTAINED IN THE
    OWNERS OPERATING AND MAINTENANCE MANUAL OF THE
    APHERESIS MACHINE TO BE USED

    RECOMMENDED STORAGE
    ROOM TEMPERATURE (25C/77F) AVOID EXCESSIVE HEAT
    PROTECT FROM FREEZING.

    FOR PRODUCT INFORMATION 1-800-933-0303

    BAXTER IS A TRADEMARK OF BAXTER INTERNATIONAL

    Baxter Logo
    BAXTER HEALTHCARE CORPORATION
    DEERFIELD IL 60015 USA

    MADE IN USA

    07-25-00-4675

  • INGREDIENTS AND APPEARANCE
    ANTICOAGULANT SODIUM CITRATE 
    trisodium citrate dihydrate solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0338-9669
    Route of AdministrationEXTRACORPOREAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL) ANHYDROUS CITRIC ACID40 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0338-9669-01250 mL in 1 BAG; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDABN98012304/02/2024
    Labeler - Baxter Healthcare Corporation (005083209)
    Establishment
    NameAddressID/FEIBusiness Operations
    Baxter Healthcare Corporation059140764MANUFACTURE(0338-9669)
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