Anticoagulant Sodium Citrate Solution USP

Manufacturer
Fenwal, Inc. | Baxter Healthcare Corporation
Effective date
2022-02-11
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-05-31 20:40:02

Label at a glance#

ProductSodium Citrate Blood-Pack Units, (PL 146 Plastic)
Active ingredientTRISODIUM CITRATE DIHYDRATE
Label structure2 sections

Label contents#

Full prescribing information#

Anticoagulant Sodium Citrate Solution USP

DESCRIPTION SECTION

A standalone direction insert does not exist for this product.

PACKAGE/LABEL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CAUTION–DO NOT REMOVE UNIT FROM OVERWRAP UNTIL READY FOR USE
THE OVERWRAP IS A MOISTURE BARRIER
THE INNER BAG MAINTAINS STERILITY OF THE PRODUCT
STORE AT CONTROLLED ROOM TEMPERATURE.

CODE 4B7889Q

NDC 0942-9504-10

500 mL

Fenwal™

Anticoagulant Sodium Citrate Solution USP

Rx only

EACH 100 mL CONTAINS 4 g SODIUM CITRATE (DIHYDRATE) USP
pH ADJUSTED WITH CITRIC ACID

STERILE
NONPYROGENIC

FOR USE WITH CYTAPHERESIS DEVICE ONLY

NOT FOR DIRECT INTRAVENOUS INFUSION

SINGLE USE CONTAINER
DISCARD UNUSED PORTION

DO NOT USE UNLESS SOLUTION IS CLEAR AND NO LEAKS ARE DETECTED

AFTER REMOVING OVERWRAP CHECK FOR MINUTE LEAKS BY SQUEEZING INNER BAG FIRMLY
IF LEAKS ARE FOUND DISCARD SOLUTION AS STERILITY MAY BE IMPAIRED

MANUFACTURED BY:
BAXTER HEALTHCARE CORPORATION
DEERFIELD, IL 60015 USA

MANUFACTURED FOR:

FENWAL, INC.
LAKE ZURICH, IL 60047 USA

MADE IN USA
07-25-58-000

PL 146 PLASTIC

Anticoagulant Sodium Citrate Solution USP label
Anticoagulant Sodium Citrate Solution USP label

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ANHYDROUS CITRIC ACID Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0942-9504-10Sodium Citrate Blood-Pack Units, (PL 146 Plastic)500 mL in 1 BAGSOLUTION5005

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0942-9504SODIUM CITRATE BLOOD-PACK UNITS, (PL 146 PLASTIC) (ANTICOAGULANT SODIUM CITRATE SOLUTION) SOLUTION [FENWAL, INC.]5Current NDC, Legacy NDC, 1 package rows20220212_ac8971a9-36d0-43c9-9121-ba5e58c28bed.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0942-9504-10ML - Milliliter0942-95044f122ad2-09f1-4766-8257-76ddc205f0d812014-02-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
TRISODIUM CITRATE DIHYDRATEACTIVE INGREDIENTB22547B95K3
Anhydrous Citric AcidACTIVE MOIETYXF417D3PSL3

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0942-95040942-9504-10

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Source Document#

Source XML · Source PDF

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sodium Citrate Blood-Pack Units, (PL 146 Plastic)ANTICOAGULANT SODIUM CITRATE SOLUTIONFenwal, Inc.ac8971a9-36d0-43c9-9121-ba5e58c28bed2022-02-11Exact identifier
ndc (package): 0942-9504-10
ndc (product): 0942-9504
ndc11 (package): 00942950410
spl id: f2b75651-90cf-4982-9762-76db5f0524d1
spl set id: ac8971a9-36d0-43c9-9121-ba5e58c28bed

Reported adverse events (FAERS/openFDA)#

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