ANTICOAGULANT SODIUM CITRATE

Product NDC: 0338-9669
Requested package NDC: 0338-9669-01
11-digit product format: 003389669
Labeler code: 0338
Product ID: 0338-9669_8855e600-2002-4c8b-94dc-d275de33169b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: trisodium citrate dihydrate
Dosage form: SOLUTION
Route: EXTRACORPOREAL
Labeler: Baxter Healthcare Corporation
Application: BN980123
Marketing category: NDA
Marketing start: 2024-04-02
Substance: TRISODIUM CITRATE DIHYDRATE
Active strength: 40 mg/mL
Pharmacologic classes: Acidifying Activity [MoA], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: ANTICOAGULANT SODIUM CITRATE
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TRISODIUM CITRATE DIHYDRATE	40 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
B22547B95K	Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
7025a0f9-1a56-4416-a3a4-925d755aed90	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0338-9669-01	ANTICOAGULANT SODIUM CITRATE	250 mL in 1 BAG	SOLUTION	250		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0338-9669	ANTICOAGULANT SODIUM CITRATE (TRISODIUM CITRATE DIHYDRATE) SOLUTION [BAXTER HEALTHCARE CORPORATION]	3	Current NDC, 1 package rows	20250410_7025a0f9-1a56-4416-a3a4-925d755aed90.zip

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ANTICOAGULANT SODIUM CITRATE	TRISODIUM CITRATE DIHYDRATE	Baxter Healthcare Corporation	7025a0f9-1a56-4416-a3a4-925d755aed90	2024-04-02		Exact identifier application number: BN980123 ndc (package): 0338-9669-01 ndc (product): 0338-9669 ndc11 (package): 00338966901

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
B22547B95K	TRISODIUM CITRATE DIHYDRATE	6132-04-3	TRISODIUM CITRATE DIHYDRATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
0338-9669-01	00338966901	250 mL in 1 BAG (0338-9669-01)	250 ml	2024-04-02	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ANTICOAGULANT SODIUM CITRATE 4% w/v SOLUTION USP	Baxter Healthcare Corporation	2024-04-02	HUMAN PRESCRIPTION DRUG LABEL	4