Anticoagulant Sodium Citrate Solution, USP Code 798-60

Manufacturer: Medsep Corporation
Effective date: 2011-05-20
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 4
Source: full-release
Hydrated at: 2026-05-31 20:15:18

Label at a glance#

ProductAnticoagulant Sodium Citrate

Active ingredientSODIUM CITRATE

Label structure7 sections

Indications and uses

For use with automated plasmapheresis equipment only. Use according to equipment manufacturer’s instructions. This unit should be used for plasmapheresis only.

Contacts and useful links#

PhoneLabel contact1.800.645.6578

Websitewww.pall.com

www.pall.com/medical

Label contents#

Full prescribing information#

ANTICOAGULANT SODIUM CITRATE SOLUTION, USP

DESCRIPTION SECTION

Sterile, non-pyrogenic fluid path. Sterilized by steam.

Rx only.

250 ml volume bag.

Store at room temperature.

INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

For use with automated plasmapheresis equipment only. Use according to equipment manufacturer’s instructions. This unit should be used for plasmapheresis only.

WARNINGS

WARNINGS SECTION

Not for direct intravenous infusion.

DO NOT VENT.

Avoid excessive heat. Protect from freezing.

GENERAL PRECAUTIONS

PRECAUTIONS SECTION

Do not use unless solution is clear and no leaks are detected.

Discard unused portion.

HOW SUPPLIED

HOW SUPPLIED SECTION

Single Use Container.

INFORMATION FOR PATIENTS

INFORMATION FOR PATIENTS SECTION

Medsep Corporation, A Subsidiary of Pall Corp., Covina, CA 91722, USA

Visit us at www.pall.com/medical

For Pall customer service, call: 1.800.645.6578

CONTAINER TEXT DISPLAYED

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ANTICOAGULANT SODIUM CITRATE SOLUTION, USP

250 mL Code 798-60

For use with automated plasmapheresis equipment only. Each 250 mL of anticoagulant contains 10.0 g sodium citrate (dihydrate), USP (pH adjusted with citric acid, USP).

CAUTION: Not for direct intravenous infusion.

Do not use unless anticoagulant is clear. This unit should be used for plasmapheresis only. Sterile, nonpyrogenic fluid path. Sterilized by steam. Rx Only.

DO NOT VENT.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Issued August 2010, 147798603

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
ANHYDROUS CITRIC ACID Pharmacologic Class Indexing	3	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
62646-798-60	2019-10-29	C162847	48780-1	960f7f55-c506-8e05-e053-dbdaa90a074a	Anticoagulant Sodium Citrate Solution, USP Code 798-60

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
62646-798-60	Anticoagulant Sodium Citrate	250 mL in 1 BAG	SOLUTION	250		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
62646-798	ANTICOAGULANT SODIUM CITRATE (SODIUM CITRATE) SOLUTION [MEDSEP CORPORATION]	4	Legacy NDC, 1 package rows	20120613_3a8dfcfa-e034-40ca-a71f-05099015f87d.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
SODIUM CITRATE	ACTIVE INGREDIENT	1Q73Q2JULR	4
CITRIC ACID ANHYDROUS	ACTIVE MOIETY	XF417D3PSL	4
WATER	INACTIVE INGREDIENT	059QF0KO0R	4

Products#

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

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

Anticoagulant Sodium Citrate
Sodium Citrate
CITRIC ACID ANHYDROUS
WATER

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
62646-798	62646-798-60

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
Name	UNII	Kind
SODIUM CITRATE	1Q73Q2JULR	ACTIB
WATER	059QF0KO0R	IACT

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog.

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
a083fb8e-3012-4d12-94d3-949a3188aba3			3a8dfcfa-e034-40ca-a71f-05099015f87d	2011-05-20	Warnings	Exact identifier spl id: a083fb8e-3012-4d12-94d3-949a3188aba3 spl set id: 3a8dfcfa-e034-40ca-a71f-05099015f87d

Reported adverse events (FAERS/openFDA)#

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