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 November 27, 2019

If you are a consumer or patient please visit this version.

  • 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

  • PACKAGE/LABEL DISPLAY PANEL

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

  • INGREDIENTS AND APPEARANCE
    ACD-A 
    anticoagulant citrate dextrose solution formula a solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0942-0641
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Dextrose Monohydrate (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK) Dextrose Monohydrate12.25 g  in 500 mL
    Sodium Citrate (UNII: 1Q73Q2JULR) (Anhydrous Citric Acid - UNII:XF417D3PSL) Sodium Citrate11 g  in 500 mL
    Anhydrous Citric Acid (UNII: XF417D3PSL) (Anhydrous Citric Acid - UNII:XF417D3PSL) Anhydrous Citric Acid3.65 g  in 500 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0942-0641-03500 mL in 1 BAG; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDABN16091803/01/2007
    Labeler - Fenwal, Inc. (794519020)
    Registrant - Fenwal, Inc. (794519020)
    Establishment
    NameAddressID/FEIBusiness Operations
    Fenwal International, Inc.091164590MANUFACTURE(0942-0641)