Home NDC 0338-9669 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 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.
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.
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