Label: ANTICOAGULANT CITRATE DEXTROSE A ACD-A injection, solution

  • NDC Code(s): 43203-852-47
  • Packager: Arteriocyte Medical Systems, Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated December 17, 2018

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    ACD-A 50 mL
    Catalog # AMSACD-A

    Anticoagulant intended for use only with devices that prepare Platelet Rich Plasma (PRP) products for extracorporeal use. See Operator's Manuals for additional information and complete usage instructions.

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

    Rx only. Single use container.

  • Caution

    Not for preparation of blood products for transfusion or for direct intravenous infusion.

  • Recommended storage

    Room temperature (68° to 77°F, 20° to 25°C)

    Avoid excessive heat. Protect from freezing.

  • Each 10mL contains

    Citric Acid Monohydrate USP0.08 g
    Sodium Citrate Dihydrate USP0.220 g
    Dextrose Monohydrate USP0.245 g
    In Water for Injection USP
  • SPL UNCLASSIFIED SECTION

    Manufactured for Arteriocyte Medical Systems, Inc.
    45 South Street, Hopkinton, MA., 01748
    by Ivex Pharmaceuticals, Larne, BT40 2SH, UK.

    ARTERIOCYTE
    CELLULAR THERAPIES
    MEDICAL SYSTEMS

    Lot
    Expiry Date

  • PRINCIPAL DISPLAY PANEL - 50 Pouch Case Label

    Anticoagulant Citrate Dextrose Solution,
    Solution A USP ACD-A

    50 mL
    50 x 50 mL

    Catalog # AMSACD-A

    Anticoagulant intended for use only with devices that prepare Platelet Rich
    Plasma (PRP) products for extracorporeal use. See Operator's Manuals for
    additional information and complete usage instructions.

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

    Caution: Not for preparation of blood products for transfusion or for direct
    intravenous infusion.

    Storage Conditions: Room temperature (68° to 77°F, 20° to 25°C)
    Avoid excessive heat. Protect from freezing. Protect from direct sunlight.

    Each 10mL contains:

    Citric Acid Monohydrate USP
    0.08 g
    Sodium Citrate Dihydrate USP
    0.220 g
    Dextrose Monohydrate USP
    0.245 g
    In Water for Injection USP

    Manufactured for Arteriocyte Medical Systems, Inc.
    45 South Street, Hopkinton, MA., 01748
    by Ivex Pharmaceuticals, Larne, BT40 2SH, UK.

    ARTERIOCYTE
    CELLULAR THERAPIES
    MEDICAL SYSTEMS

    Lot
    Expiry Date

    PRINCIPAL DISPLAY PANEL - 50 Pouch Case Label
  • INGREDIENTS AND APPEARANCE
    ANTICOAGULANT CITRATE DEXTROSE A ACD-A 
    anticoagulant citrate dextrose a acd-a injection, solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:43203-852
    Route of AdministrationEXTRACORPOREAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL) ANHYDROUS CITRIC ACID0.08 g  in 10 mL
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM CITRATE, UNSPECIFIED FORM0.220 g  in 10 mL
    DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK) DEXTROSE MONOHYDRATE0.245 g  in 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R) 9.76 g  in 10 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43203-852-4750 in 1 CASE
    11 in 1 POUCH
    150 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
    ANDABA11005705/11/2011
    Labeler - Arteriocyte Medical Systems, Inc. (809012870)
    Registrant - Terumo BCT, Inc. (801679200)
    Establishment
    NameAddressID/FEIBusiness Operations
    Terumo BCT, Ltd.233649834MANUFACTURE(43203-852) , ANALYSIS(43203-852) , STERILIZE(43203-852) , LABEL(43203-852)