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Haemonetics Anticoagulant Citrate Dextrose Solution (Haemonetics Corporation)

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SOLUTION 500 mL in 1 BAG (57826-426-04) Label Information

Complete Haemonetics Anticoagulant Citrate Dextrose Solution Information

  • HAEMONETICS ANTICOAGULANT CITRATE DEXTROSE SOLUTION, USP, FORMULA A (ACDA)

    500 mL for use only with automated apheresis devices  Each 100 mL contains  Citric Acid (anhydrous), USP   0.73 g  Sodium Citrate (hydrous), USP   2.20 g  Dextrose (hydrous), USP   2.45 g


  • CAUTION:

    Not for direct intravenous infusion. Do not use unless solution is clear and no leaks detected. Single use container. Discard unused portion. Sterile, pyrogen free solution.  Rx only.


  • RECOMMENDED STORAGE:

    Room temperature (25 degree C/77 degree F). Avoid excessive heat. Protect from freezing.


  • Product code

    L331-01  Product code 426A  Haemonetics Corporation Braintree, MA 02184 USA  Lot No.    Exp. Date


  • PRINCIPAL DISPLAY PANEL

    HAEMONETICS  ANTICOAGULANT CITRATE DEXTROSE SOLUTION, USP, FORMULA A (ACDA)  500 mL Haemonetics Corporation


  • Product Label

    Label


  • INGREDIENTS AND APPEARANCE
    HAEMONETICS ANTICOAGULANT CITRATE DEXTROSE SOLUTION  
    anhydrous citric acid, trisodium citrate dihydrate, dextrose monohydrate solution
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:57826-426
    Route of Administration EXTRACORPOREAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL) ANHYDROUS CITRIC ACID 73 mg  in 1 mL
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL) ANHYDROUS CITRIC ACID 220 mg  in 1 mL
    DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK) DEXTROSE MONOHYDRATE 245 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:57826-426-04 500 mL in 1 BAG; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA BA980728 01/10/2013
    Labeler - Haemonetics Corporation (942344649)
    Establishment
    Name Address ID/FEI Business Operations
    Haemonetics Corporation 942344649 manufacture(57826-426)