FDA.reportPublic FDA data

Sodium Citrate w/v Anticoagulant

Manufacturer
Terumo BCT, Ltd
Effective date
2025-01-24
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 21:24:16

Label at a glance#

ProductSodium Citrate w/v Anticoagulant
Active ingredientTRISODIUM CITRATE DIHYDRATE
Label structure12 sections

Indications and uses

SODIUM CITRATE 4% W/V ANTICOAGULANT SOLUTION USP is intended for use only for the anticoagulation of whole blood as part of automated apheresis procedures. [See Dosage and Administration (2) .]

Dosage and administration

SODIUM CITRATE 4% W/V ANTICOAGULANT SOLUTION USP is added to tubing sets during apheresis procedures. The solution bag 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 a...

Storage and handling

SODIUM CITRATE 4% W/V ANTICOAGULANT SOLUTION USP is a clear solution supplied in sterile and non-pyrogenic polyolefin bags. The bags are packaged 30 bags per case. SIZE CATALOG NUMBER NDC NUMBER 250 mL 40883 Bag: 14537-883-00 Case: 14537-883-03 STORAGE Up to 25 °C. Protect from freezing.

Label contents#

Full prescribing information#

1 INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

SODIUM CITRATE 4% W/V ANTICOAGULANT SOLUTION USP is intended for use only for the anticoagulation of whole blood as part of automated apheresis procedures. [See Dosage and Administration (2).]

2 DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

2.1 General Dosing Information

SPL UNCLASSIFIED SECTION

SODIUM CITRATE 4% W/V ANTICOAGULANT SOLUTION USP is added to tubing sets during apheresis procedures. The solution bag 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 SODIUM CITRATE 4% W/V ANTICOAGULANT SOLUTION USP 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 SODIUM CITRATE 4% W/V ANTICOAGULANT SOLUTION USP 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 SODIUM CITRATE 4% W/V ANTICOAGULANT SOLUTION USP 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 SODIUM CITRATE 4% W/V ANTICOAGULANT SOLUTION USP and is within the expiration date.
    • Inspect the solution in good 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. 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 the solution and container permit.

3 DOSAGE FORMS AND STRENGTHS

DOSAGE FORMS & STRENGTHS SECTION

250 mL SODIUM CITRATE 4% W/V ANTICOAGULANT SOLUTION USP is a sterile solution in a polyolefin bag. Each 100 mL contains: Sodium Citrate (dihydrate) 4.0 g; Water for Injection to 100 mL, (pH adjusted with citric acid). Approximate millimoles of Sodium Citrate: 13.8.

4 CONTRAINDICATIONS

CONTRAINDICATIONS SECTION

DO NOT INFUSE SODIUM CITRATE 4% W/V ANTICOAGULANT SOLUTION USP DIRECTLY TO THE DONOR.

5 WARNINGS AND PRECAUTIONS

WARNINGS AND PRECAUTIONS SECTION

  • Verify that the SODIUM CITRATE 4% W/V ANTICOAGULANT SOLUTION USP 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.
  • Single-use container. Do not reuse. Discard any unused or partially used product.
  • Rx only.

6 ADVERSE REACTIONS

ADVERSE REACTIONS SECTION

Citrate reactions or toxicity may occur with the infusion of blood products to patients and return of blood containing citrate anticoagulant to donors. 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

SODIUM CITRATE 4% W/V ANTICOAGULANT SOLUTION USP has not been adequately studied in controlled clinical trials with specific populations.

11 DESCRIPTION

DESCRIPTION SECTION

SODIUM CITRATE 4% W/V ANTICOAGULANT SOLUTION USP 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. Sterilized with steam.

The formulas of the active ingredients are provided in Table 1.

Table 1: Active Ingredients
IngredientsMolecular FormulaMolecular Weight
Sodium Citrate DihydrateC6H9Na3O9 294.10
Water for InjectionH2O18.00

Each 100 mL of SODIUM CITRATE 4% W/V ANTICOAGULANT SOLUTION USP contains: Sodium Citrate (dihydrate) 4.0 g; and Water for Injection to 100 mL (pH adjusted with citric acid). Approximate millimoles of sodium citrate: 13.8.

The polyolefin bag is not made with natural rubber latex.

The bag contains materials that have been tested to demonstrate the suitability of the container for storing pharmaceutical solutions. 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

SODIUM CITRATE 4% W/V ANTICOAGULANT SOLUTION USP 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 anticoagulant

This solution has no pharmacological effect.

16 HOW SUPPLIED/STORAGE AND HANDLING

HOW SUPPLIED SECTION

SODIUM CITRATE 4% W/V ANTICOAGULANT SOLUTION USP is a clear solution supplied in sterile and non-pyrogenic polyolefin bags. The bags are packaged 30 bags per case.

SIZECATALOG NUMBERNDC NUMBER
250 mL40883Bag:14537-883-00
Case:14537-883-03

STORAGE AND HANDLING SECTION

STORAGE

Up to 25 °C.

Protect from freezing.

SPL UNCLASSIFIED SECTION

Issued: December 2019

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

PRINCIPAL DISPLAY PANEL - 250 mL Bag Carton Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Sodium Citrate 4% w/v Anticoagulant Solution USP

Catalog # 40883
Polyolefin Bag
30 x 250 mL units

NDC 14537-883-03

Indications for use: For use only for the anticoagulation of whole blood
as part of automated apheresis procedures. See apheresis device
operator's manual for complete instructions. Read the package insert
before application. The solution is sterile and non-pyrogenic, and it
contains no bacteriostatic or antimicrobial agents. Sterilized with Steam.

Caution: Use only if solution is clear. Do not use if the container is
damaged. Single use container. Discard any unused product.
Not for direct intravenous infusion. Rx Only.

Recommended storage: Up to 25 °C. Protect from freezing.

Each 100 mL contains:
Sodium Citrate Dihydrate
4.0 g
Water for Injection to
(pH adjusted with citric acid)
100 mL
Approximate Millimoles:
Sodium Citrate
13.8

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

TERUMOBCT
0000000783

Lot
Expiry Date

PRINCIPAL DISPLAY PANEL - 250 mL Bag Carton Label
PRINCIPAL DISPLAY PANEL - 250 mL Bag Carton Label

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ANHYDROUS CITRIC ACID Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
14537-883-00Sodium Citrate w/v Anticoagulant250 mL in 1 BAGINJECTION, SOLUTION2502
14537-883-03Sodium Citrate w/v Anticoagulant30 in 1 CARTONINJECTION, SOLUTION302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
14537-883SODIUM CITRATE W/V ANTICOAGULANT (TRISODIUM CITRATE DIHYDRATE) INJECTION, SOLUTION [TERUMO BCT, LTD]2Current NDC, Legacy NDC, 2 package rows20250129_c9d0e9c8-379f-4895-b272-329efab575c4.zip

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
14537-88314537-883-00, 14537-883-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
TRISODIUM CITRATE DIHYDRATEB22547B95KACTIM
water059QF0KO0RIACT
Citric Acid monohydrate2968PHW8QPIACT

Source Document#

Source XML

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
Sodium Citrate w/v AnticoagulantTRISODIUM CITRATE DIHYDRATETerumo BCT, Ltdc9d0e9c8-379f-4895-b272-329efab575c42025-01-24Warnings, Adverse reactionsExact identifier
ndc (package): 14537-883-00
ndc (package): 14537-883-03
ndc (product): 14537-883
ndc11 (package): 14537088300
ndc11 (package): 14537088303
spl id: 4e4eaf1d-b071-4ee8-83ea-739e6388b3b4
spl set id: c9d0e9c8-379f-4895-b272-329efab575c4

Reported adverse events (FAERS/openFDA)#

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