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

  • NDC Code(s): 14537-810-12, 14537-810-75
  • Packager: Terumo BCT, Ltd
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated May 21, 2026

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

View All Sections
  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use Anticoagulant Citrate Dextrose Solution USP (ACD) Solution A safely and effectively. See full prescribing information for Anticoagulant Citrate Dextrose Solution USP (ACD) Solution A.

    Anticoagulant Citrate Dextrose Solution USP (ACD) Solution A

    Initial U.S. Approval: 1987

    Dosage form: Sterile solution
    Route of administration: Extracorporeal administration from a polyolefin bag

    INDICATIONS AND USAGE

    Anticoagulant Citrate Dextrose Solution USP (ACD) Solution A is an anticoagulant for blood collection for use only with apheresis devices. (1)

    DOSAGE AND ADMINISTRATION

    • Anticoagulant Citrate Dextrose Solution USP (ACD) Solution A is added to tubing sets during apheresis procedures. (2)
    • Anticoagulant Citrate Dextrose Solution USP (ACD) Solution A may only be used with apheresis devices. For instructions on the use of the solution see the apheresis device operator's manual. (2.1)
    • Follow the directions for connecting the Anticoagulant Citrate Dextrose Solution USP (ACD) Solution A bag to the apheresis system. (2.2)

    DOSAGE FORMS AND STRENGTHS

    750 mL sterile fluid in polyolefin bag. (3)

    CONTRAINDICATIONS

    None. (4)

    WARNINGS AND PRECAUTIONS

    Verify that the Anticoagulant Citrate Dextrose Solution USP (ACD) Solution A has been securely attached to the anticoagulant (AC) line on the system tubing set. Use aseptic technique throughout all procedures to ensure product quality and donor safety. Do not infuse Anticoagulant Citrate Dextrose Solution USP (ACD) Solution A directly to the patients. (5)

    ADVERSE REACTIONS

    The following potential adverse reactions are safety-related harms associated with the use of Anticoagulant Citrate Dextrose Solution USP (ACD) Solution A: embolism, toxic reaction, infection, hypervolemia, and tissue damage.


    Citrate reactions or toxicity may occur with the infusion and return of blood containing citrate anticoagulant. The recipient of the blood containing citrate should be monitored for the signs and symptoms of citrate toxicity. (6)


    To report SUSPECTED ADVERSE REACTIONS, contact Terumo BCT, Inc. at 1-877-339-4228 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

    DRUG INTERACTIONS

    There are no known significant interactions between Anticoagulant Citrate Dextrose Solution USP (ACD) Solution A and food or other drug products. (7)

    USE IN SPECIFIC POPULATIONS

    Anticoagulant Citrate Dextrose Solution USP (ACD) Solution A has not been studied in controlled clinical trials with specific populations. (8)

    Revised: 1/2026

  • Table of Contents

    FULL PRESCRIBING INFORMATION: CONTENTS*

    1 INDICATIONS AND USAGE

    2 DOSAGE AND ADMINISTRATION

    2.1 General Dosing Information

    2.2 Administration

    3 DOSAGE FORMS AND STRENGTHS

    4 CONTRAINDICATIONS

    5 WARNINGS AND PRECAUTIONS

    6 ADVERSE REACTIONS

    7 DRUG INTERACTIONS

    8 USE IN SPECIFIC POPULATIONS

    11 DESCRIPTION

    12 CLINICAL PHARMACOLOGY

    12.1 Mechanism of Action

    13 NONCLINICAL TOXICOLOGY

    13.1 Carcinogenesis, mutagenesis, impairment of fertility

    16 HOW SUPPLIED/STORAGE AND HANDLING

    *
    Sections or subsections omitted from the full prescribing information are not listed.
  • 1 INDICATIONS AND USAGE

    Anticoagulant Citrate Dextrose Solution USP (ACD) Solution A is an anticoagulant for blood collection for use only with apheresis devices. [See Dosage and Administration (2).]

  • 2 DOSAGE AND ADMINISTRATION

    2.1 General Dosing Information

    Anticoagulant Citrate Dextrose Solution USP (ACD) Solution A is added to tubing sets during apheresis procedures. The solution is connected to the tubing set in an apheresis collection. For automated apheresis, the recommended dose is determined by the apheresis device and metered into the tubing set by the apheresis device. It is not intended for direct intravenous infusion.

    For instructions on the use of the solution with an apheresis device and tubing set, see that device's operator's manual.

    2.2 Administration

    • Ensure solution is the Anticoagulant Citrate Dextrose Solution USP (ACD) Solution A and the expiration date has not passed.
    • Inspect the bag. Do not use the solution if the container is damaged, leaking, or if there is any visible sign of deterioration.
    • Use only if the solution is clear and free of particulate matter.
    • Protect the bag from sharp objects.
    • Use aseptic technique throughout all procedures.

    Directions for connecting the Anticoagulant Citrate Dextrose Solution USP (ACD) Solution A bag to the apheresis device.

    At the prompt to connect anticoagulant to the apheresis device tubing set:

    1. Remove the overwrap by pulling down at the notch, and remove the Anticoagulant Citrate Dextrose Solution USP (ACD) Solution A bag.
    2. Before use, perform the following checks [See Warnings and Precautions (5).]:
      • Check for leaks by gently squeezing the bag. If you find leaks, discard the bag.
      • Ensure that the solution is the Anticoagulant Citrate Dextrose Solution USP (ACD) Solution A and the expiration date has not passed.
      • Inspect the solution in adequate light. Do not use bags that show cloudiness, haze, or particulate matter.
    3. Remove the protective cap from the port on the bag.
    4. Connect the bag to the apheresis device tubing set using aseptic technique and hang the solution.
    5. Proceed according to the apheresis device's operator's manual.

    Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

  • 3 DOSAGE FORMS AND STRENGTHS

    750 mL Anticoagulant Citrate Dextrose Solution USP (ACD) Solution A is a sterile solution in a polyolefin bag. Each 100 mL contains: (%w/v) Citric Acid, Monohydrate 0.8 g; Dextrose Monohydrate 2.45 g; Sodium Citrate Dihydrate 2.2 g; and Water for Injection.

  • 4 CONTRAINDICATIONS

    None. There are no known contraindications associated with the use of the product.

  • 5 WARNINGS AND PRECAUTIONS

    • Verify that the Anticoagulant Citrate Dextrose Solution USP (ACD) Solution A has been securely attached to the Anticoagulant (AC) line on the system tubing set.
    • Use aseptic technique throughout all procedures to ensure product quality and donor safety.
    • Do not reuse. Discard unused or partially used solution bags.
    • Do not infuse Anticoagulant Citrate Dextrose Solution USP (ACD) Solution A directly to the patients.
    • Do not use the solution if the container is damaged, leaking, or if there is any visible sign of deterioration.
  • 6 ADVERSE REACTIONS

    The following potential adverse events are associated with the use of Anticoagulant Citrate Dextrose Solution USP (ACD) Solution A: embolism, toxic reaction, infection, hypervolemia, and tissue damage.

    Citrate reactions or toxicity may occur with the infusion and return of blood containing citrate anticoagulant. The recipient of the blood containing citrate should be monitored for the signs and symptoms of citrate toxicity. The signs and symptoms of citrate toxicity begin with paresthesia, a "tingling" sensation around the mouth or in the extremities, followed by severe reactions that are characterized by hypotension and possible cardiac arrhythmia. Citrate toxicity may occur more frequently in patients who are hypothermic, have impaired liver or renal function, or have low calcium levels because of an underlying disease.

    Report suspected adverse reactions to Terumo BCT, Inc. or the FDA.

  • 7 DRUG INTERACTIONS

    There are no known significant interactions between Anticoagulant Citrate Dextrose Solution USP (ACD) Solution A and food or other drug products.

  • 8 USE IN SPECIFIC POPULATIONS

    Anticoagulant Citrate Dextrose Solution USP (ACD) Solution A has not been studied in controlled clinical trials with specific populations.

  • 11 DESCRIPTION

    Anticoagulant Citrate Dextrose Solution USP (ACD) Solution A is designed to be metered by an apheresis device in apheresis procedures, to prevent platelet activation and coagulation as blood moves throughout the extracorporeal unit (tubing set) in an apheresis procedure.

    The solution is sterile and non-pyrogenic, and it contains no bacteriostatic or antimicrobial agents.

    The formulas of the ingredients are provided in Table 1.

    Table 1: Ingredients
    IngredientsStructural/Molecular FormulaMolecular Weight
    (%w/v) Citric Acid, Monohydrate
    (active ingredient)    		C6H8O7192.12
    Dextrose Monohydrate
    (active ingredient)    		C6H12O6 ∙ H2O198.17
    Sodium Citrate Dihydrate
    (active ingredient)    		C6H9Na3O9294.10
    Water for Injection
    (inactive ingredient)    		H2O18.00

    Each 100 mL of Anticoagulant Citrate Dextrose Solution USP (ACD) Solution A contains: (%w/v) Citric Acid, Monohydrate 0.8 g; Dextrose Monohydrate 2.45 g; Sodium Citrate Dihydrate 2.2 g; and Water for Injection.

    The polyolefin bag is not made with natural rubber latex or PVC.

    The bag is made from a multilayered film. It contains materials that have been tested to demonstrate the suitability of the container for storing pharmaceutical solutions. The solution contact layer is an elasticized polyolefin. The bag is nontoxic and biologically inert. The bag-solution unit is a closed system and is not dependent upon entry of external air during administration. The bag is overwrapped to provide protection from the physical environment and to provide an additional moisture barrier when necessary.

  • 12 CLINICAL PHARMACOLOGY

    12.1 Mechanism of Action

    Anticoagulant Citrate Dextrose Solution USP (ACD) Solution A acts as an extracorporeal anticoagulant by binding the free calcium in the blood. Calcium is a necessary co-factor to several steps in the clotting cascade. The following ingredients are key components of the solution:

    • Citric Acid for pH regulation
    • Sodium Citrate for anticoagulation
    • Dextrose for isotonicity

    This solution has no pharmacological effect.

  • 13 NONCLINICAL TOXICOLOGY

    13.1 Carcinogenesis, mutagenesis, impairment of fertility

    No long-term animal studies have been performed to evaluate carcinogenic potential.

  • 16 HOW SUPPLIED/STORAGE AND HANDLING

    Anticoagulant Citrate Dextrose Solution USP (ACD) Solution A is a clear solution supplied in sterile and non-pyrogenic polyolefin bags. The 750 mL bags are packaged 12 bags per case.

    SIZECATALOG NUMBERNDC NUMBER
    750 mL4081014537-810-75 (bag level)
    14537-810-12 (case level)

    Store up to 25 °C.

    Avoid excessive heat. Protect from freezing.

  • SPL UNCLASSIFIED SECTION

    Issued: <TBD—FDA Approval: MONTH YYYY>

    Terumo BCT is either a registered trademark or trademark of Terumo BCT, Inc. in the United States and/or other countries.

    This product may be covered by one or more patents or pending patent applications. See www.terumobct.com/patents for details.

    Made in UK

    Manufactured by
    Terumo BCT, Inc.
    Lakewood, CO 80215

  • PRINCIPAL DISPLAY PANEL - 750 mL Carton Label

    Anticoagulant Citrate Dextrose Solution USP (ACD) Solution A

    NDC 14537-810-12
    Catalog # 40810
    12 x 750 mL units

    STERILE

    Sterile. Non-pyrogenic. Sterilized with Steam.

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

    Read the package insert before application. For use only with apheresis devices.
    See apheresis device operator's manual for complete instructions.

    No antimicrobial agents have been added.

    Discard unused portion.

    Caution: Not for direct intravenous infusion.

    Recommended storage: Store up to 25 °C. 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 West Collins Ave., Lakewood Colorado 80215-4440, USA
    Made in UK

    Lot

    Expiry Date

    1000084243

    PRINCIPAL DISPLAY PANEL - 750 mL Carton Label
  • INGREDIENTS AND APPEARANCE
    ACD  A
    citric acid monohydrate, dextrose monohydrate, and trisodium citrate dihydrate injection, solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:14537-810
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Citric Acid Monohydrate (UNII: 2968PHW8QP) (Anhydrous Citric Acid - UNII:XF417D3PSL) Anhydrous Citric Acid0.8 g  in 100 mL
    Dextrose Monohydrate (UNII: LX22YL083G) (Anhydrous Dextrose - UNII:5SL0G7R0OK) Dextrose Monohydrate2.45 g  in 100 mL
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K) (Anhydrous Citric Acid - UNII:XF417D3PSL) Anhydrous Citric Acid2.2 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:14537-810-1212 in 1 CARTON
    1NDC:14537-810-75750 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
    ANDABA01022806/01/2026
    Labeler - Terumo BCT, Ltd (233649834)
    Registrant - Terumo BCT, Inc. (801679200)
    Establishment
    NameAddressID/FEIBusiness Operations
    Terumo BCT, Ltd233649834LABEL(14537-810) , ANALYSIS(14537-810) , STERILIZE(14537-810) , MANUFACTURE(14537-810) , PACK(14537-810)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!