Label: ACD A- dextrose monohydrate, sodium citrate, and citric acid monohydrate injection, solution

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated January 10, 2019

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  • SPL UNCLASSIFIED SECTION

    Catalog # 40800
    12 × 750 mL units

    NDC 14537-967-75

  • DESCRIPTION

    Sterile. Non-pyrogenic. Do not use unless the solution is clear and the container is intact. Rx Only. Single use container.

    For use only with apheresis devices. See apheresis device operator's manual for complete instructions.

  • Caution

    Not for direct intravenous infusion.

  • Recommended storage

    Store up to 25 °C. (See USP Controlled Room Temperature).

    Avoid excessive heat. Protect from freezing.

  • HOW SUPPLIED

    Each 100 mL contains:
      Dextrose Monohydrate USP2.45 g
      Sodium Citrate Dihydrate USP2.20 g
      Citric Acid Monohydrate USP0.80 g
      In Water for Injection USP
  • SPL UNCLASSIFIED SECTION

    Manufactured by Terumo BCT, Inc.
    10811 W. Collins Ave., Lakewood CO 80215, USA

    777967-066

    Lot
    Expiry Date

  • PRINCIPAL DISPLAY PANEL - 12 Bag Case Label

    Anticoagulant Citrate Dextrose
    Solution USP (ACD) Solution A

    Catalog # 40800
    12 x 750 mL units

    NDC 14537-967-75

    Sterile. Non-pyrogenic. Do not use unless the solution is clear
    and the container is intact. Rx Only. Single use container.
    For use only with apheresis devices. See apheresis device
    operator's manual for complete instructions.

    Caution: Not for direct intravenous infusion.

    Recommended storage: Store up to 25 °C. (See USP
    Controlled Room Temperature).
    Avoid excessive heat. Protect from freezing.

    Each 100 mL contains:

    Dextrose Monohydrate USP 2.45 g
    Sodium Citrate Dihydrate USP 2.20 g
    Citric Acid Monohydrate USP 0.80 g
    In Water for Injection USP

    Manufactured by Terumo BCT, Inc.
    10811 W. Collins Ave., Lakewood CO 80215, USA

    777967-066
    TERUMOBCT

    Lot
    Expiry Date

    Principal Display Panel - 12 Bag Case Label
  • INGREDIENTS AND APPEARANCE
    ACD   A
    dextrose monohydrate, sodium citrate, and citric acid monohydrate injection, solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:14537-967
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Dextrose Monohydrate (UNII: LX22YL083G) (Anhydrous Dextrose - UNII:5SL0G7R0OK) Dextrose Monohydrate2.45 g  in 100 mL
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) (Sodium Cation - UNII:LYR4M0NH37) SODIUM CITRATE, UNSPECIFIED FORM2.2 g  in 100 mL
    Citric Acid Monohydrate (UNII: 2968PHW8QP) (Anhydrous Citric Acid - UNII:XF417D3PSL) Anhydrous Citric Acid0.80 g  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:14537-967-7512 in 1 CASE
    1750 mL in 1 BAG; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDABA01022802/25/2002
    Labeler - Terumo BCT Ltd (233649834)
    Establishment
    NameAddressID/FEIBusiness Operations
    Terumo BCT Ltd.233649834MANUFACTURE(14537-967) , STERILIZE(14537-967) , LABEL(14537-967) , ANALYSIS(14537-967)
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