ANTICOAGULANT SODIUM CITRATE

Product NDC
0338-9669
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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TRISODIUM CITRATE DIHYDRATE40 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiB22547B95K

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0338-9669-01ANTICOAGULANT SODIUM CITRATE250 mL in 1 BAGSOLUTION2504

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0338-9669ANTICOAGULANT SODIUM CITRATE (TRISODIUM CITRATE DIHYDRATE) SOLUTION [BAXTER HEALTHCARE CORPORATION]3Current NDC, 1 package rows20250410_7025a0f9-1a56-4416-a3a4-925d755aed90.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0338-9669-0100338966901250 mL in 1 BAG (0338-9669-01) 250 ml2024-04-02NoNoCurrent