{"effective_time":"20240402","how_supplied":["HOW SUPPLIED Anticoagulant Sodium Citrate 4% w/v Solution, USP is a clear solution supplied in sterile and nonpyrogenic PVC bags per carton. Storage and Handling Store at room temperature (25C/77F). Avoid excessive heat. Protect from freezing."],"id":"8855e600-2002-4c8b-94dc-d275de33169b","indications_and_usage":["INDICATIONS AND USAGE Anticoagulant Sodium Citrate 4% w/v Solution, USP is intended for use only with automated apheresis devices."],"openfda":{"application_number":["BN980123"],"brand_name":["ANTICOAGULANT SODIUM CITRATE"],"generic_name":["TRISODIUM CITRATE DIHYDRATE"],"is_original_packager":[true],"manufacturer_name":["Baxter Healthcare Corporation"],"package_ndc":["0338-9669-01"],"product_ndc":["0338-9669"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["EXTRACORPOREAL"],"spl_id":["8855e600-2002-4c8b-94dc-d275de33169b"],"spl_set_id":["7025a0f9-1a56-4416-a3a4-925d755aed90"],"substance_name":["TRISODIUM CITRATE DIHYDRATE"],"unii":["B22547B95K"]},"package_label_principal_display_panel":["PACKAGE/LABEL PRINCIPAL DISPLAY PANEL LOT EXP 2B7867 NDC 0338-9669-01 Anticoagulant Sodium Citrate 4% w/v Solution USP Rx only 250 mL EACH 100 mL CONTAINS 4 g SODIUM CITRATE (DIHYDRATE) USP pH ADJUSTED WITH CITRIC ACID STERILE NONPYROGENIC INTENDED FOR USE ONLY WITH AUTOMATED APHERESIS DEVICES CAUTION — NOT FOR DIRECT INTRAVENOUS INFUSION THE POUCH IS A MOISTURE BARRIER DO NOT USE UNLESS SOLUTION IS CLEAR SQUEEZE AND INSPECT INNER BAG WHICH MAINTAINS PRODUCT STERILITY DISCARD IF LEAKS ARE FOUND SINGLE USE CONTAINER DISCARD UNUSED PORTION DIRECTIONS FOR USE ARE CONTAINED IN THE OWNERS OPERATING AND MAINTENANCE MANUAL OF THE APHERESIS MACHINE TO BE USED RECOMMENDED STORAGE ROOM TEMPERATURE (25C/77F) AVOID EXCESSIVE HEAT PROTECT FROM FREEZING. FOR PRODUCT INFORMATION 1-800-933-0303 BAXTER IS A TRADEMARK OF BAXTER INTERNATIONAL Baxter Logo BAXTER HEALTHCARE CORPORATION DEERFIELD IL 60015 USA MADE IN USA 07-25-00-4675 Carton Label"],"set_id":"7025a0f9-1a56-4416-a3a4-925d755aed90","spl_product_data_elements":["ANTICOAGULANT SODIUM CITRATE trisodium citrate dihydrate TRISODIUM CITRATE DIHYDRATE ANHYDROUS CITRIC ACID WATER"],"spl_unclassified_section":["ADMINISTRATION The pouch is a moisture barrier. Do not remove from pouch until ready to use. Do not use unless solution is clear and no leaks detected. Do not use unless port protector is in place.","DOSAGE FORMS AND STRENGTHS Anticoagulant Sodium Citrate 4% w/v Solution, USP in the 250 mL single dose container is a sterile solution that contains 4g Sodium Citrate Dihydrate, USP per 100 mL, pH adjusted with citric acid.","PRECAUTIONS Not for direct intravenous infusion."],"storage_and_handling":["Storage and Handling Store at room temperature (25C/77F). Avoid excessive heat. Protect from freezing."],"version":"4"}