ANTICOAGULANT SODIUM CITRATE- trisodium citrate dihydrate solution

ANTICOAGULANT SODIUM CITRATE by

Drug Labeling and Warnings

ANTICOAGULANT SODIUM CITRATE by is a Prescription medication manufactured, distributed, or labeled by Baxter Healthcare Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

INDICATIONS AND USAGE

Anticoagulant Sodium Citrate 4% w/v Solution, USP is intended for use only with automated apheresis devices.

ADMINISTRATION

The pouch is a moisture barrier. Do not remove from pouch until ready to use. Do not use unless solution is clear and no leaks detected. Do not use unless port protector is in place.

DOSAGE FORMS AND STRENGTHS

Anticoagulant Sodium Citrate 4% w/v Solution, USP in the 250 mL single dose container is a sterile solution that contains 4g Sodium Citrate Dihydrate, USP per 100 mL, pH adjusted with citric acid.

PRECAUTIONS

Not for direct intravenous infusion.

HOW SUPPLIED

Anticoagulant Sodium Citrate 4% w/v Solution, USP is a clear solution supplied in sterile and nonpyrogenic PVC bags per carton.

Storage and Handling

Store at room temperature (25C/77F). Avoid excessive heat. Protect from freezing.

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

LOT

EXP

2B7867
NDC: 0338-9669-01

Anticoagulant
Sodium Citrate
4% w/v
Solution USP

Rx only

250 mL EACH 100 mL CONTAINS 4 g SODIUM
CITRATE (DIHYDRATE) USP
pH ADJUSTED WITH CITRIC ACID
STERILE NONPYROGENIC
INTENDED FOR USE ONLY WITH AUTOMATED APHERESIS
DEVICES
CAUTION — NOT FOR DIRECT INTRAVENOUS INFUSION THE
POUCH IS A MOISTURE BARRIER DO NOT USE UNLESS
SOLUTION IS CLEAR SQUEEZE AND INSPECT INNER BAG
WHICH MAINTAINS PRODUCT STERILITY DISCARD IF LEAKS
ARE FOUND SINGLE USE CONTAINER DISCARD UNUSED
PORTION DIRECTIONS FOR USE ARE CONTAINED IN THE
OWNERS OPERATING AND MAINTENANCE MANUAL OF THE
APHERESIS MACHINE TO BE USED

RECOMMENDED STORAGE
ROOM TEMPERATURE (25C/77F) AVOID EXCESSIVE HEAT
PROTECT FROM FREEZING.

FOR PRODUCT INFORMATION 1-800-933-0303

BAXTER IS A TRADEMARK OF BAXTER INTERNATIONAL

Baxter Logo
BAXTER HEALTHCARE CORPORATION
DEERFIELD IL 60015 USA

MADE IN USA

07-25-00-4675

INGREDIENTS AND APPEARANCE

ANTICOAGULANT SODIUM CITRATE 
trisodium citrate dihydrate solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 0338-9669
Route of Administration	EXTRACORPOREAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL)	ANHYDROUS CITRIC ACID	40 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0338-9669-01	250 mL in 1 BAG; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	BN980123	04/02/2024

Labeler - Baxter Healthcare Corporation (005083209)

Establishment
Name	Address	ID/FEI	Business Operations
Baxter Healthcare Corporation		059140764	MANUFACTURE(0338-9669)