{"effective_time":"20251125","id":"1b32fa60-df62-4ab3-86ed-db2a262de054","openfda":{"application_number":["BN160918"],"brand_name":["ACD-A"],"generic_name":["ANTICOAGULANT CITRATE DEXTROSE SOLUTION FORMULA A"],"is_original_packager":[true],"manufacturer_name":["Fenwal, Inc."],"nui":["N0000175833","N0000175835","N0000175980","N0000008556","N0000175089"],"package_ndc":["0942-0641-04"],"pharm_class_epc":["Calculi Dissolution Agent [EPC]","Anti-coagulant [EPC]"],"pharm_class_moa":["Acidifying Activity [MoA]","Calcium Chelating Activity [MoA]"],"pharm_class_pe":["Decreased Coagulation Factor Activity [PE]"],"product_ndc":["0942-0641"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["INTRAVENOUS"],"spl_id":["1b32fa60-df62-4ab3-86ed-db2a262de054"],"spl_set_id":["ab19b011-0a51-4f04-9881-d9fc7cae95ae"],"substance_name":["DEXTROSE MONOHYDRATE","SODIUM CITRATE, UNSPECIFIED FORM","ANHYDROUS CITRIC ACID"],"unii":["LX22YL083G","1Q73Q2JULR","XF417D3PSL"]},"package_label_principal_display_panel":["PACKAGE/LABEL DISPLAY PANEL A label of a medicine AI-generated content may be incorrect."],"set_id":"ab19b011-0a51-4f04-9881-d9fc7cae95ae","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"],"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 RECOMMENDED STORAGE–STORE AT CONTROLLED ROOM TEMPERATURE. CODE 4B7891X NDC 0942-0641-04 1000 mL Fenwal™ Rx only 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 65 Pitts Station Rd. Marion, NC 28752 USA Manufactured for: Fenwal, Inc. Lake Zurich, IL 60047 USA Fenwal P/N072516810 Made in USA LABEL ISSUE DATE 07/2023 07-25-00-4194 logo"],"version":"7"}