{"effective_time":"20250613","id":"dddc74d0-e63a-431b-a222-12c45bdc0c16","openfda":{"application_number":["ANDA203428"],"brand_name":["Furosemide"],"generic_name":["FUROSEMIDE"],"is_original_packager":[true],"manufacturer_name":["Maiva Pharma Private Limited"],"nui":["N0000175366","N0000175590"],"package_ndc":["73542-101-25","73542-102-25","73542-103-25"],"pharm_class_epc":["Loop Diuretic [EPC]"],"pharm_class_pe":["Increased Diuresis at Loop of Henle [PE]"],"product_ndc":["73542-101","73542-102","73542-103"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["INTRAVENOUS"],"rxcui":["1719286","1719290","1719291"],"spl_id":["dddc74d0-e63a-431b-a222-12c45bdc0c16"],"spl_set_id":["e5880bf4-5037-4813-b7cc-656a6832ecb5"],"substance_name":["FUROSEMIDE"],"unii":["7LXU5N7ZO5"]},"package_label_principal_display_panel":["PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 73542- 101- 01 Furosemide Injection, USP 20 mg/2 mL (10 mglmL) FOR IV OR IM USE Rx only 2 mL Single-Dose vial NDC 73542- 101 -25 Furosemide Injection, USP 20 mg/2 mL (10 mglmL) FOR IV OR IM USE Rx only 25 Single-Dose vial vial-label-2ml carton-label-2ml","PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 73542- 102 -02 Furosemide Injection, USP 40 mg/4 mL (10 mglmL) FOR IV OR IM USE Rx only 4 mL Single-Dose vial NDC 73542- 102 -25 Furosemide Injection, USP 40 mg/4 mL (10 mglmL) FOR IV OR IM USE Rx only 25 Single-Dose via vial-label-4ml carton-label-4ml","PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 73542- 103 -03 Furosemide Injection, USP 100 mg/10 mL (10 mglmL) FOR IV OR IM USE Rx only 10 mL Single-Dose vial NDC 73542- 103 -25 Furosemide Injection, USP 100 mg/10 mL (10 mglmL) FOR IV OR IM USE Rx only 25 Single-Dose vial vial-label-10ml carton-label-10ml"],"set_id":"e5880bf4-5037-4813-b7cc-656a6832ecb5","spl_product_data_elements":["Furosemide Furosemide FUROSEMIDE FUROSEMIDE SODIUM CHLORIDE SODIUM HYDROXIDE HYDROCHLORIC ACID WATER Furosemide Furosemide FUROSEMIDE FUROSEMIDE SODIUM CHLORIDE SODIUM HYDROXIDE HYDROCHLORIC ACID WATER Furosemide Furosemide FUROSEMIDE FUROSEMIDE SODIUM CHLORIDE SODIUM HYDROXIDE HYDROCHLORIC ACID WATER"],"version":"1","warnings":["WARNINGS Furosemide is a potent diuretic which, if given in excessive amounts, can lead to a profound diuresis with water and electrolyte depletion. Therefore, careful medical supervision is required and dose and dose schedule must be adjusted to the individual patient's needs. (See DOSAGE AND ADMINISTRATION.)"]}