ACD-A- anticoagulant citrate dextrose solution formula a solution

ACD-A by

Drug Labeling and Warnings

ACD-A by is a Prescription medication manufactured, distributed, or labeled by Fenwal Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Anticoagulant Citrate Dextrose Solution USP (ACD) Formula A

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

RECOMMENDED STORAGE–STORE AT CONTROLLED ROOM TEMPERATURE.

CODE 4B7891X
NDC: 0942-0641-04

1000 mL

Fenwal™

Anticoagulant Citrate Dextrose Solution USP (ACD) Formula A

EACH 100 mL CONTAINS 2.45 g DEXTROSE (MONOHYDRATE) USP 2.2 g SODIUM CITRATE (DIHYDRATE) USP 730 mg CITRIC ACID (ANHYDROUS) USP

STERILE

NONPYROGENIC

SINGLE USE CONTAINER

DISCARD UNUSED PORTION

FOR USE WITH CYTAPHERESIS DEVICE ONLY

NOT FOR DIRECT INTRAVENOUS INFUSION

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

Rx only

PL 146 PLASTIC

Manufactured by:
Baxter Healthcare Corporation
Deerfield, IL 60015 USA

Manufactured for:
Fenwal, Inc.
Lake Zurich, IL 60047 USA

07-25-58-006         Made in USA

LABEL ISSUE DATE    05/2008

PACKAGE/LABEL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ACD-A 
anticoagulant citrate dextrose solution formula a solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 0942-0641
Route of Administration	INTRAVENOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Dextrose Monohydrate (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK)	Dextrose Monohydrate	24.5 g  in 1000 mL
Sodium Citrate (UNII: 1Q73Q2JULR) (Anhydrous Citric Acid - UNII:XF417D3PSL)	Sodium Citrate	22 g  in 1000 mL
Anhydrous Citric Acid (UNII: XF417D3PSL) (Anhydrous Citric Acid - UNII:XF417D3PSL)	Anhydrous Citric Acid	7.3 g  in 1000 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0942-0641-04	1000 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	BN160918	03/01/2007

Labeler - Fenwal, Inc. (794519020)

Registrant - Fenwal, Inc. (794519020)

Establishment
Name	Address	ID/FEI	Business Operations
Fenwal International, Inc.		091164590	MANUFACTURE(0942-0641)