FDA.reportPublic FDA data

Haemonetics Anticoagulant Sodium Citrate

Manufacturer
Haemonetics Corporation
Effective date
2021-02-02
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
12
Source
legacy-cache
Hydrated at
2026-08-01 22:52:57

Label at a glance#

ProductHaemonetics Anticoagulant Sodium Citrate
Active ingredientTRISODIUM CITRATE DIHYDRATE
Label structure6 sections

Storage and handling

Room temperature (25°C/77°F). Avoid excess heat. Protect from freezing.

Label contents#

Full prescribing information#

HAEMONETICS ANTICOAGULANT SODIUM CITRATE 4% w/v SOLUTION USP

SPL UNCLASSIFIED SECTION

Rx only                        250 mL 

Intended for use only with automated apheresis devices.

Each 100 mL contains: Sodium Citrate (Dihydrate), USP 4.0g 
(pH adjusted with Citric Acid, Monohydrate, USP)

CAUTION:

WARNINGS SECTION

Not for direct intravenous infusion. The pouch is a moisture barrier. Do not use unless solution is clear and no leaks detected. Single use container. Discard unused portion.

SPL UNCLASSIFIED SECTION

STERILE, nonpyrogenic fluid path.

Product code

INFORMATION FOR PATIENTS SECTION

Product Code 420A
117881-00, Rev. AA-XXX

Haemonetics Corporation
400 Wood Road
Braintree, MA 02184 USA

Product Labeling

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

label 2label 2

label 3label 3

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
TRISODIUM CITRATE DIHYDRATEACTIVE INGREDIENTB22547B95K5
ANHYDROUS CITRIC ACIDACTIVE MOIETYXF417D3PSL5
WATERINACTIVE INGREDIENT059QF0KO0R5

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
57826-42057826-420-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
TRISODIUM CITRATE DIHYDRATEB22547B95KACTIM

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
2bd83d69-9dc5-16a7-e063-6294a90a6959447528e6-55cd-4a9b-868e-2a741b2693d32025-01-16WarningsExact identifier
spl set id: 447528e6-55cd-4a9b-868e-2a741b2693d3

Reported adverse events (FAERS/openFDA)#

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