Label: HAEMONETICS ANTICOAGULANT SODIUM CITRATE- trisodium citrate dihydrate solution

  • NDC Code(s): 57826-420-02
  • Packager: Haemonetics Corporation
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated February 2, 2021

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  • 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

    label 2

    label 3

  • INGREDIENTS AND APPEARANCE
    HAEMONETICS ANTICOAGULANT SODIUM CITRATE 
    trisodium citrate dihydrate solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:57826-420
    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:57826-420-02250 mL in 1 BAG; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDABN98012301/10/2013
    Labeler - Haemonetics Corporation (057827420)
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