Anticoagulant Sodium Citrate
These highlights do not include all the information needed to use ANTICOAGULANT SODIUM CITRATE 4 % W/V SOLUTION USP safely and effectively. See full prescribing information for ANTICOAGULANT SODIUM CITRATE 4 % W/V SOLUTION USP. ANTICOAGULANT SODIUM CITRATE 4 % W/V SOLUTION USP Sterile Fluid PVC Bag Initial U.S. Approval: 1978
Approved
Approval ID
1798dd96-5ae7-4a8b-b433-24ca9b38d863
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 10, 2024
Manufacturers
FDA
CSL Plasma Inc.
DUNS: 942344649
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Trisodium Citrate Dihydrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code81839-782
Application NumberBA125750
Product Classification
M
Marketing Category
C73584
G
Generic Name
Trisodium Citrate Dihydrate
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateMay 5, 2022
FDA Product Classification
INGREDIENTS (3)
WaterInactive
Code: 059QF0KO0R
Classification: IACT
Citric Acid monohydrateInactive
Code: 2968PHW8QP
Classification: IACT
Trisodium Citrate DihydrateActive
Quantity: 40 mg in 1 mL
Code: B22547B95K
Classification: ACTIM