Label: ACD-A- anticoagulant citrate dextrose solution formula a solution
- NDC Code(s): 0942-0641-03
- Packager: Fenwal, Inc.
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated February 11, 2022
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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 TEMPERATURECODE 4B7898Q
NDC 0942-0641-03500 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 28752MADE IN USA 07-25-57-867 REV: B
Manufactured for:
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INGREDIENTS AND APPEARANCE
ACD-A
anticoagulant citrate dextrose solution formula a solutionProduct 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 12.25 g in 500 mL SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) (Anhydrous Citric Acid - UNII:XF417D3PSL) SODIUM CITRATE, UNSPECIFIED FORM 11 g in 500 mL Anhydrous Citric Acid (UNII: XF417D3PSL) (Anhydrous Citric Acid - UNII:XF417D3PSL) Anhydrous Citric Acid 3.65 g in 500 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0942-0641-03 500 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 Baxter Healthcare Corporation 059140764 MANUFACTURE(0942-0641)
Fenwal, Inc.
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