{"effective_time":"20260414","id":"fa83d193-9cfc-40c0-b924-b1685c50d08a","openfda":{"application_number":["BA125697"],"brand_name":["Anticoagulant Sodium Citrate"],"generic_name":["TRISODIUM CITRATE DIHYDRATE"],"is_original_packager":[true],"manufacturer_name":["LABORATORIOS GRIFOLS SA"],"package_ndc":["76297-006-02","76297-006-03","76297-006-04"],"product_ndc":["76297-006"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["EXTRACORPOREAL"],"spl_id":["fa83d193-9cfc-40c0-b924-b1685c50d08a"],"spl_set_id":["db8334be-5b8b-4811-811a-efbe32b6d147"],"substance_name":["TRISODIUM CITRATE DIHYDRATE"],"unii":["B22547B95K"]},"package_label_principal_display_panel":["PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 76297-006-04 Anticoagulant Sodium Citrate 4% w/v Solution, USP 250 mL Rx Only Intended for use only with automated apheresis devices. Not for direct intravenous infusion. RECOMMENDED STORAGE: Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Brief exposure up to 40°C (104°F) does not adversely affect the product. Protect from freezing. LOT XXXXXX EXP YYYY-MM 39 x 250 mL Num.: GRIFOLS Laboratorios Grifols, S. A. SPAIN LOT: XXXXXX EXP: YYYY-MM NDC 76297-006-02 Anticoagulant Sodium Citrate 4% w/v Solution, USP 250 mL Rx Only Intended for use only with automated apheresis devices Each 100 mL contains: Sodium Citrate (Dihydrate), USP 4.0 g (pH adjusted with Citric Acid, Monohydrate, USP) Caution: Not for direct intravenous infusion. The pouch is a moisture barrier. Do not use unless solution is clear and no leaks detected. Single use container. Discard unused portion. STERILE, nonpyrogenic fluid path. RECOMMENDED STORAGE: Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Brief exposure up to 40°C (104°F) does not adversely affect the product. Protect from freezing. Laboratorios Grifols, S. A. SPAIN GRIFOLS"],"set_id":"db8334be-5b8b-4811-811a-efbe32b6d147","spl_product_data_elements":["Anticoagulant Sodium Citrate Trisodium Citrate Dihydrate Trisodium Citrate Dihydrate Anhydrous Citric Acid Water Citric Acid Monohydrate container-76297-006-02.jpg Label"],"spl_unclassified_section":["ANTICOAGULANT SODIUM CITRATE 4% w/v SOLUTION USP Rx only 250 mL Intended for use only with automated apheresis devices. Each 100 mL contains: Sodium Citrate (Dihydrate), USP 4.0 g (pH adjusted with Citric Acid, Monohydrate, USP)","STERILE, nonpyrogenic fluid path.","Laboratorios Grifols, S. A. SPAIN Revision: 10/2019"],"storage_and_handling":["RECOMMENDED STORAGE: Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature]. Brief exposure up to 40°C (104°F) does not adversely affect the product. Protect from freezing."],"version":"7","warnings":["CAUTION Not for direct intravenous infusion. The pouch is a moisture barrier. Do not use unless solution is clear and no leaks detected. Single use container. Discard unused portion."]}