Label: ACD-A- anticoagulant citrate dextrose solution formula a solution

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

Drug Label Information

Updated May 30, 2013

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  • Anticoagulant Citrate Dextrose Solution USP (ACD) Formula A

    CAUTION–

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

    CODE 4B7898Q
    NDC 0942-0641-03

    500 mL

    Fenwal™

    Anticoagulant Citrate Dextrose Solution USP (ACD) Formula A

    EACH 100 mL CONTAINS 2.45 g DEXTROSE (MONOHYDRATE) USP 2.2 g SODIUM CITRATE (DIHYDRATE) USP 730 mg CITRIC ACID (ANHYDROUS) USP

    STERILE , NONPYROGENIC

    STERILIZED BY STEAM

    SINGLE USE CONTAINER

    DISCARD UNUSED PORTION

    FOR USE WITH CYTAPHERESIS DEVICE ONLY

    NOT FOR DIRECT INTRAVENOUS INFUSION

    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

    DISPOSE OF CONTAINER APPROPRIATELY

    SEE CARTON FOR ADDITIONAL PRODUCT AND COUNTRY SPECIFIC INFORMATION

    Rx only

    PL 146 PLASTIC

    Manufactured by:
    Baxter Healthcare Corporation
    65 Pitts Station Road
    Marion, North Carolina 28752

    MADE IN USA 07-25-57-867 REV: B

    Manufactured for:

    logoFenwal, Inc.
    Lake Zurich, IL 60047 USA

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  • PACKAGE/LABEL DISPLAY PANEL

    Anticoagulant Citrate Dextrose Solution USP (ACD) Formula A label [Enter Package/Label Display Panel here]

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  • INGREDIENTS AND APPEARANCE
    ACD-A 
    anticoagulant citrate dextrose solution formula a solution
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0942-0641
    Route of Administration INTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Dextrose Monohydrate (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK) Dextrose Monohydrate 12.25 g  in 500 mL
    Sodium Citrate (UNII: 1Q73Q2JULR) (Anhydrous Citric Acid - UNII:XF417D3PSL) Sodium Citrate 11 g  in 500 mL
    Anhydrous Citric Acid (UNII: XF417D3PSL) (Anhydrous Citric Acid - UNII:XF417D3PSL) Anhydrous Citric Acid 3.65 g  in 500 mL
    Inactive Ingredients
    Ingredient Name Strength
    Water (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0942-0641-03 500 mL in 1 BAG
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA BN160918 03/01/2007
    Labeler - Fenwal Inc (794519020)
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