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  • ACD-A ANHYDROUS CITRIC ACID 3.65 g/500mL Fenwal, Inc.
FDA Drug information

ACD-A

Read time: 1 mins
Marketing start date: 27 Apr 2024
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Summary of product characteristics


Effective Time

20220211

Version

6

Spl Product Data Elements

ACD-A Anticoagulant Citrate Dextrose Solution Formula A Dextrose Monohydrate ANHYDROUS DEXTROSE SODIUM CITRATE, UNSPECIFIED FORM Anhydrous Citric Acid Anhydrous Citric Acid Anhydrous Citric Acid Water

Application Number

BN160918

Brand Name

ACD-A

Generic Name

Anticoagulant Citrate Dextrose Solution Formula A

Product Ndc

0942-0641

Product Type

HUMAN PRESCRIPTION DRUG

Route

INTRAVENOUS

Package Label Principal Display Panel

PACKAGE/LABEL DISPLAY PANEL [Enter Package/Label Display Panel here] Anticoagulant Citrate Dextrose Solution USP (ACD) Formula A label

Spl Unclassified Section

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 STORE AT CONTROLLED ROOM TEMPERATURE CODE 4B7898Q NDC 0942-0641-03 500 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 STERILIZED BY STEAM 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 DISPOSE OF CONTAINER APPROPRIATELY SEE CARTON FOR ADDITIONAL PRODUCT AND COUNTRY SPECIFIC INFORMATION Rx only PL 146 PLASTIC Manufactured by: Baxter Healthcare Corporation 65 Pitts Station Road Marion, North Carolina 28752 MADE IN USA 07-25-57-867 REV: B Manufactured for: Fenwal, Inc. Lake Zurich, IL 60047 USA logo

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