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., Fenwal International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PACKAGE/LABEL DISPLAY PANEL

Fenwal™

Anticoagulant Sodium Citrate Solution USP

Rx only

CODE 4B7867Q

NDC: 0942-9505-10

250 mL

EACH 100 mL CONTAINS 4 g SODIUM CITRATE (DIHYDRATE) USP
pH ADJUSTED WITH CITRIC ACID
STERILE
NONPYROGENIC
FOR USE WITH CYTAPHERESIS DEVICE ONLY
NOT FOR DIRECT INTRAVENOUS INFUSION
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

PL 146 PLASTIC

MANUFACTURED BY:
BAXTER HEALTHCARE CORPORATION
DEERFIELD, IL 60015 USA

MANUFACTURED FOR:

FENWAL, INC.
LAKE ZURICH, IL 60047 USA

MADE IN USA

07-25-02-996 REV: C

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: 0942-9505
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
WATER (UNII: 059QF0KO0R)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0942-9505-10	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	03/01/2007

Labeler - Fenwal, Inc. (794519020)

Registrant - Fenwal, Inc. (794519020)

Establishment
Name	Address	ID/FEI	Business Operations
Fenwal International, Inc.		091164590	MANUFACTURE(0942-9505)