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

Key Label Information#

Uses

INDICATIONS AND USAGE

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

Warnings

WARNINGS

Not for direct intravenous infusion. DO NOT VENT. Avoid excessive heat. Protect from freezing.

Other Label Information

CONTAINER TEXT DISPLAYED

Anticoagulant Sodium Citrate Bag Text 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.

Label Images#

143798603Bag
143798603Bag

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
62646-798-602019-10-29C16284748780-1960f7f55-c506-8e05-e053-dbdaa90a074aAnticoagulant Sodium Citrate Solution, USP Code 798-60

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62646-798-60Anticoagulant Sodium Citrate250 mL in 1 BAGSOLUTION2504

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62646-798ANTICOAGULANT SODIUM CITRATE (SODIUM CITRATE) SOLUTION [MEDSEP CORPORATION]4Legacy NDC, 1 package rows20120613_3a8dfcfa-e034-40ca-a71f-05099015f87d.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
SODIUM CITRATEACTIVE INGREDIENT1Q73Q2JULR4
CITRIC ACID ANHYDROUSACTIVE MOIETYXF417D3PSL4
WATERINACTIVE INGREDIENT059QF0KO0R4

Products#

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62646-79862646-798-60

Ingredients#

Name, UNII, Kind table
NameUNIIKind
SODIUM CITRATE1Q73Q2JULRACTIB
WATER059QF0KO0RIACT

Complete SPL Sections#

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 Bag Text 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.

Source Document#

Source XML