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FDA Drug information

Sodium Citrate Blood-Pack Units, (PL 146 Plastic)

Read time: 1 mins
Marketing start date: 20 Apr 2025
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Summary of product characteristics


Effective Time

20221107

Version

3

Spl Product Data Elements

Sodium Citrate Blood-Pack Units, (PL 146 Plastic) Anticoagulant Sodium Citrate Solution TRISODIUM CITRATE DIHYDRATE ANHYDROUS CITRIC ACID CITRIC ACID MONOHYDRATE

Application Number

BN770923

Brand Name

Sodium Citrate Blood-Pack Units, (PL 146 Plastic)

Generic Name

Anticoagulant Sodium Citrate Solution

Product Ndc

0942-9506

Product Type

HUMAN PRESCRIPTION DRUG

Route

INTRAVENOUS

Package Label Principal Display Panel

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL CODE 6B7801 NDC 0942-9506-25 250mL Fresenius Kabi Rx only ANTICOAGULANT SODIUM CITRATE SOLUTION USP NOT FOR DIRECT INTRAVENOUS INFUSION EACH 100 mL CONTAINS 4 g SODIUM CITRATE (DIHYDRATE) USP pH ADJUSTED WITH CITRIC ACID STERILE NONPYROGENIC FOR USE WITH APHERESIS DEVICE ONLY 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 CAUTION – DO NOT REMOVE UNIT FROM OVERWRAP UNTIL READY FOR USE THE OVERWRAP IS A MOISTURE BARRIER THE INNER BAG MAINTAINS THE STERILITY OF THE PRODUCT STORE AT CONTROLLED ROOM TEMPERATURE FRESENIUS KABI AG 61346 BAD HOMBURG / GERMANY TEL.: +49 (0)6172 686-0 www.fresenius-kabi.com Made in MX 47-25-13-348 REV: A packlbl6b7801

Spl Unclassified Section

Anticoagulant Sodium Citrate Solution USP A standalone direction insert does not exist for this product.

Drug section

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