FDA.reportPublic FDA data

ACD A - Terumo BCT, Ltd.

Manufacturer
Terumo BCT, Ltd.
Effective date
2026-06-15
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
7
Source
daily-update
Hydrated at
2026-07-15 00:33:18

Label at a glance#

ProductACD A
Active ingredientCitric Acid Monohydrate, Dextrose Monohydrate, Trisodium Citrate Dihydrate
Label structure13 sections

Indications and uses

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) .]

Dosage and administration

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. 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 the apheresis ...

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. The 500 mL bags are packaged 18 bags per case. SIZE CATALOG NUMBER NDC NUMBER 500 mL 40815 14537-815-50 750 mL 40817 14537-817-75 STORAGE Store up to 25 °C [See USP Controlled Room Temperature]. Avoid excessive heat. Protect from free...

Label contents#

Full prescribing information#

1 INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

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

DOSAGE & ADMINISTRATION SECTION

2.1 General Dosing Information

SPL UNCLASSIFIED SECTION

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. 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 the apheresis device and tubing set, see the device operator's manual.

2.2 Administration

SPL UNCLASSIFIED SECTION

  • Ensure solution is the ANTICOAGULANT CITRATE DEXTROSE SOLUTION USP (ACD) SOLUTION A and is within the expiration date.
  • Inspect the bag. Do not use if the container is damaged, leaking or if there is any visible sign of deterioration.
  • Use only if solution is clear and free of particulate matter.
  • Protect from sharp objects.
SPL UNCLASSIFIED SECTION

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 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 leaks are found, discard the bag.
    • Ensure that the solution is the ANTICOAGULANT CITRATE DEXTROSE SOLUTION USP (ACD) SOLUTION A and is within the expiration date.
    • Inspect the solution in adequate light. Bags showing cloudiness, haze, or particulate matter should not be used.
  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. Break the frangible connector. When you break frangible connectors, bend them in both directions to ensure that you break them completely. Failure to do so may result in restricted flow.
  6. Proceed according to the apheresis device 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

DOSAGE FORMS & STRENGTHS SECTION

500 mL or 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

CONTRAINDICATIONS SECTION

DO NOT INFUSE ANTICOAGULANT CITRATE DEXTROSE SOLUTION USP (ACD) SOLUTION A DIRECTLY TO THE PATIENTS.

5 WARNINGS AND PRECAUTIONS

WARNINGS AND PRECAUTIONS SECTION

  • 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 donor safety and quality.
  • Do not reuse. Discard unused or partially used solution bags.

6 ADVERSE REACTIONS

ADVERSE REACTIONS SECTION

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.

8 USE IN SPECIFIC POPULATIONS

USE IN SPECIFIC POPULATIONS SECTION

ANTICOAGULANT CITRATE DEXTROSE SOLUTION USP (ACD) SOLUTION A has not been adequately studied in controlled clinical trials with specific populations.

11 DESCRIPTION

DESCRIPTION SECTION

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 active ingredients are provided in Table 1.

Table 1: Active Ingredients
IngredientsMolecular Formula Molecular Weight
(%w/v) Citric Acid, MonohydrateC6H8O7 192.12
Dextrose MonohydrateC6H12O6 ∙ H2O198.17
Sodium Citrate DihydrateC6H9Na3O9 294.10
Water for InjectionH2O18.00

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

CLINICAL PHARMACOLOGY SECTION

12.1 Mechanism of Action

MECHANISM OF ACTION SECTION

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 anticoagulates
  • Dextrose for isotonicity

This solution has no pharmacological effect.

16 HOW SUPPLIED/STORAGE AND HANDLING

HOW SUPPLIED SECTION

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. The 500 mL bags are packaged 18 bags per case.

SIZECATALOG NUMBERNDC NUMBER
500 mL4081514537-815-50
750 mL4081714537-817-75

STORAGE AND HANDLING SECTION

STORAGE

Store up to 25 °C [See USP Controlled Room Temperature].
Avoid excessive heat. Protect from freezing.

SPL UNCLASSIFIED SECTION

Issued: (August 2017)

Manufactured by
Terumo BCT, Inc.
Lakewood, CO 80215

PRINCIPAL DISPLAY PANEL - 750 mL Bag Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Anticoagulant Citrate Dextrose
Solution USP (ACD) Solution A

Catalog # 40817
Polyolefin Bag
750 mL

NDC 14537-817-75

Sterile. Non-pyrogenic. Sterilized with Steam.

Do not use unless the solution is clear and the
container is intact.

Rx Only.

Single use container.

Read the package insert before application.

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

777967-057
TERUMOBCT

Lot
Expiry Date

PRINCIPAL DISPLAY PANEL - 750 mL Bag Label
PRINCIPAL DISPLAY PANEL - 750 mL Bag Label

PRINCIPAL DISPLAY PANEL - 500 mL Bag Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Anticoagulant Citrate Dextrose
Solution USP (ACD) Solution A

Catalog # 40815
Polyolefin Bag
500 mL

NDC 14537-815-50

Sterile. Non-pyrogenic. Sterilized with Steam.

Do not use unless the solution is clear and the
container is intact.

Rx Only.

Single use container.

Read the package insert before application.

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

777967-540
TERUMOBCT

Lot
Expiry Date

PRINCIPAL DISPLAY PANEL - 500 mL Bag Label
PRINCIPAL DISPLAY PANEL - 500 mL Bag Label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
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f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
14537-81714537-817-75
14537-81514537-815-50

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
Citric Acid Monohydrate2968PHW8QPACTIM
Dextrose MonohydrateLX22YL083GACTIB
Trisodium Citrate DihydrateB22547B95KACTIM
Water059QF0KO0RIACT
Citric Acid Monohydrate2968PHW8QPACTIM
Dextrose MonohydrateLX22YL083GACTIB
Trisodium Citrate DihydrateB22547B95KACTIM
Water059QF0KO0RIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
52025-01-22full-release2026-05-31 21:23:58

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ACD ACITRIC ACID MONOHYDRATE, DEXTROSE MONOHYDRATE, AND TRISODIUM CITRATE DIHYDRATETerumo BCT, Ltd.395aec48-198a-4aed-8e38-7accfb3232f92026-06-15Warnings, Adverse reactionsExact identifier
ndc (package): 14537-815-50
ndc (package): 14537-817-75
ndc (product): 14537-817
ndc (product): 14537-815
ndc11 (package): 14537081550
ndc11 (package): 14537081775
spl id: 518c3dfd-9690-4d10-b330-6f2f50a36851
spl set id: 395aec48-198a-4aed-8e38-7accfb3232f9

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.