SODIUM CITRATE BLOOD-PACK UNITS, (PL 146 PLASTIC)- anticoagulant sodium citrate solution solution

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

Drug Labeling and Warnings

Sodium Citrate Blood-Pack Units, (PL 146 Plastic) by is a Prescription medication manufactured, distributed, or labeled by Fenwal, Inc., Fresenius Medical Care de Mexico, S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Anticoagulant Sodium Citrate Solution USP

A standalone direction insert does not exist for this product.

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

INGREDIENTS AND APPEARANCE

SODIUM CITRATE BLOOD-PACK UNITS, (PL 146 PLASTIC) 
anticoagulant sodium citrate solution solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 0942-9506
Route of Administration	INTRAVENOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL)	ANHYDROUS CITRIC ACID	4 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0942-9506-25	250 mL in 1 BAG; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	BN770923	09/29/2014

Labeler - Fenwal, Inc. (794519020)

Establishment
Name	Address	ID/FEI	Business Operations
Fresenius Medical Care de Mexico, S.A. de C.V.		812652287	ANALYSIS(0942-9506) , STERILIZE(0942-9506) , LABEL(0942-9506) , MANUFACTURE(0942-9506) , PACK(0942-9506)