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Sodium Citrate w/v Anticoagulant

These highlights do not include all the information needed to use SODIUM CITRATE 4% W/V ANTICOAGULANT SOLUTION USP safely and effectively. See full prescribing information for SODIUM CITRATE 4% W/V ANTICOAGULANT SOLUTION USP. SODIUM CITRATE 4% W/V ANTICOAGULANT SOLUTION USP Sterile FluidPolyolefin Bag Initial U.S. Approval: 1978

Approved
Approval ID

c9d0e9c8-379f-4895-b272-329efab575c4

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 21, 2020

Manufacturers
FDA

Terumo BCT, Ltd

DUNS: 233649834

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 Code14537-883
Application NumberBA125608
Product Classification
M
Marketing Category
C73584
G
Generic Name
TRISODIUM CITRATE DIHYDRATE
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 31, 2019
FDA Product Classification

INGREDIENTS (3)

Citric Acid monohydrateInactive
Code: 2968PHW8QP
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
TRISODIUM CITRATE DIHYDRATEActive
Quantity: 4 g in 100 mL
Code: B22547B95K
Classification: ACTIM

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Sodium Citrate w/v Anticoagulant - FDA Drug Approval Details