Anticoagulant Sodium Citrate

Manufacturer
LABORATORIOS GRIFOLS SA | Laboratorios Grifols, S.A. | Laboratorios Grifols, S. A.
Effective date
2026-04-14
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-05-31 22:15:37

Label at a glance#

ProductAnticoagulant Sodium Citrate
Active ingredientTrisodium Citrate Dihydrate
Label structure6 sections

Storage and handling

Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature]. Brief exposure up to 40°C (104°F) does not adversely affect the product. Protect from freezing.

Label contents#

Full prescribing information#

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 4.0 g
(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.

SPL UNCLASSIFIED SECTION

Laboratorios Grifols, S. A.
SPAIN
Revision: 10/2019

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 76297-006-04

Anticoagulant Sodium Citrate 4% w/v
Solution, USP       250 mL


Rx Only

Intended for use only with automated apheresis devices.

Not for direct intravenous infusion.

RECOMMENDED STORAGE: Store at 20° to 25°C (68° to 77°F); excursions permitted
between 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].
Brief exposure up to 40°C (104°F) does not adversely affect the product.
Protect from freezing.
  

LOT  XXXXXX          EXP  YYYY-MM

39 x 250 mL

Num.:

GRIFOLS
Laboratorios Grifols, S. A. SPAIN

Label
Label

LOT: XXXXXX          EXP: YYYY-MM

NDC 76297-006-02

Anticoagulant Sodium Citrate 4% w/v
Solution, USP         250 mL

Rx Only

Intended for use only with automated apheresis devices

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

Caution: 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.

STERILE, nonpyrogenic fluid path.

RECOMMENDED STORAGE: Store at 20° to 25°C (68° to 77°F); excursions
permitted between 15° to 30°C (59° to 86°F) [See USP Controlled Room
Temperature]. Brief exposure up to 40°C (104°F) does not adversely affect the
product. Protect from freezing. 

Laboratorios Grifols, S. A. SPAIN

GRIFOLS

container-76297-006-02.jpg
container-76297-006-02.jpg

DailyMed Pharmacologic Classes#

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
Data codeData Matrix4000601Container label.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76297-006-02Anticoagulant Sodium Citrate250 mL in 1 BAGSOLUTION2507
76297-006-03Anticoagulant Sodium Citrate30 in 1 CARTONSOLUTION307
76297-006-04Anticoagulant Sodium Citrate39 in 1 CARTONSOLUTION397

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76297-00676297-006-02, 76297-006-03, 76297-006-04

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

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
Anticoagulant Sodium CitrateTRISODIUM CITRATE DIHYDRATELABORATORIOS GRIFOLS SAdb8334be-5b8b-4811-811a-efbe32b6d1472026-04-14WarningsExact identifier
ndc (package): 76297-006-04
ndc (package): 76297-006-03
ndc (package): 76297-006-02
ndc (product): 76297-006
ndc11 (package): 76297000604
ndc11 (package): 76297000603
ndc11 (package): 76297000602
spl id: fa83d193-9cfc-40c0-b924-b1685c50d08a
spl set id: db8334be-5b8b-4811-811a-efbe32b6d147

Reported adverse events (FAERS/openFDA)#

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