{"effective_time":"20260729","id":"2ba33fab-05a6-42db-9b4a-277bb3a30f29","openfda":{"application_number":["NDA209080"],"brand_name":["TIGLUTIK"],"generic_name":["RILUZOLE"],"is_original_packager":[true],"manufacturer_name":["Italfarmaco SPA"],"nui":["N0000175740","M0483511"],"package_ndc":["11797-210-01"],"pharm_class_cs":["Benzothiazoles [CS]"],"pharm_class_epc":["Benzothiazole [EPC]"],"product_ndc":["11797-210"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["ORAL"],"rxcui":["2058147","2059266"],"spl_id":["2ba33fab-05a6-42db-9b4a-277bb3a30f29"],"spl_set_id":["20b7165a-eb4d-42a0-b2d8-16eff90a214e"],"substance_name":["RILUZOLE"],"unii":["7LJ087RS6F"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 300 mL Bottle Carton NDC 11797-210-01 R x only Tiglutik ® riluzole oral suspension 50 mg/10 mL (5 mg/mL) For Oral Administration Shake gently before use Contents of this package: Two bottles, each containing 300 mL Two 10 mL oral syringes Two syringe bottle adapters Two syringe tip caps One Prescribing Information, including Instructions for Use This product is a liquid suspension and is supplied with syringes for oral administration. Before use, please read the enclosed Prescribing Information. 600 mL (two bottles/300 mL each) Not To Be Dispensed Separately PRINCIPAL DISPLAY PANEL - 300 mL Bottle Carton"],"set_id":"20b7165a-eb4d-42a0-b2d8-16eff90a214e","spl_product_data_elements":["TIGLUTIK Riluzole MAGNESIUM ALUMINUM SILICATE SORBITOL POLYOXYL 20 CETOSTEARYL ETHER WATER SACCHARIN SODIUM SILICON DIOXIDE DIMETHICONE, UNSPECIFIED SODIUM LAURYL SULFATE XANTHAN GUM RILUZOLE RILUZOLE slightly brown, opaque"],"spl_unclassified_section":[""],"version":"1"}