Label: HAEMONETICS ANTICOAGULANT CITRATE DEXTROSE SOLUTION- anhydrous citric acid, trisodium citrate dihydrate, dextrose monohydrate solution

  • NDC Code(s): 57826-426-04
  • Packager: Haemonetics Corporation
  • Category: HUMAN PRESCRIPTION DRUG LABEL

Drug Label Information

Updated January 5, 2021

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  • 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 TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:57826-426
    Route of AdministrationEXTRACORPOREAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL) ANHYDROUS CITRIC ACID73 mg  in 1 mL
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL) ANHYDROUS CITRIC ACID220 mg  in 1 mL
    DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK) DEXTROSE MONOHYDRATE245 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57826-426-04500 mL in 1 BAG; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDABA98072801/10/2013
    Labeler - Haemonetics Corporation (057827420)
    Establishment
    NameAddressID/FEIBusiness Operations
    Haemonetics Corporation057827420manufacture(57826-426)