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Haemonetics Anticoagulant Sodium Citrate (Haemonetics Corporation)

Available Formats

Dosage Form Package Information Links
SOLUTION 250 mL in 1 BAG (57826-420-02) Label Information

Complete Haemonetics Anticoagulant Sodium Citrate Information

  • HAEMONETICS ANTICOAGULANT SODIUM CITRATE 4% w/v SOLUTION USP

    Rx only                        250 mL 

    Intended for use only with automated apheresis devices.

    Each 100 mL contains: Sodium Citrate (Dihydrate), USP 4.0g 
    (pH adjusted with Citric Acid, Monohydrate, USP)


  • CAUTION:

    Not for direct intravenous infusion. The pouch is a moisture barrier. Do not use unless solution is clear and no leaks detected. Single use container. Discard unused portion.


  • SPL UNCLASSIFIED SECTION

    STERILE, nonpyrogenic fluid path.


  • RECOMMENDED STORAGE:

    Room temperature (25°C/77°F). Avoid excess heat. Protect from freezing.


  • Product code

    Product Code 420A
    117881-00, Rev. AA-XXX

    Haemonetics Corporation
    400 Wood Road
    Braintree, MA 02184 USA


  • Product Labeling

    Label

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  • INGREDIENTS AND APPEARANCE
    HAEMONETICS ANTICOAGULANT SODIUM CITRATE  
    trisodium citrate dihydrate solution
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:57826-420
    Route of Administration EXTRACORPOREAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL) ANHYDROUS CITRIC ACID 40 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:57826-420-02 250 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
    NDA BN980123 01/10/2013
    Labeler - Haemonetics Corporation (942344649)