{"adverse_reactions":["6 ADVERSE REACTIONS No adverse reactions have been reported for Ammonia N 13 Injection based on a review of the published literature, publicly available reference sources, and adverse drug reaction reporting systems. However, the completeness of these sources is not known. No adverse reactions have been reported for Ammonia N 13 Injection based on a review of the published literature, publicly available reference sources, and adverse drug reaction reporting system (6) . To report SUSPECTED ADVERSE REACTIONS, contact Kreitchman PET Center at 212-305-0081 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch."],"effective_time":"20260127","id":"bf01478c-3377-4b2c-905c-30807e865825","openfda":{"application_number":["ANDA203938"],"brand_name":["Ammonia N 13"],"generic_name":["AMMONIA N-13"],"is_original_packager":[true],"manufacturer_name":["Kreitchman PET Center"],"nui":["N0000177914","N0000000205"],"package_ndc":["62072-456-56"],"pharm_class_epc":["Radioactive Diagnostic Agent [EPC]"],"pharm_class_moa":["Radiopharmaceutical Activity [MoA]"],"product_ndc":["62072-456"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["INTRAVENOUS"],"spl_id":["bf01478c-3377-4b2c-905c-30807e865825"],"spl_set_id":["26572b37-0999-4c83-8206-1c088026d407"],"substance_name":["AMMONIA N-13"],"unii":["9OQO0E343Z"]},"package_label_principal_display_panel":["product label"],"set_id":"26572b37-0999-4c83-8206-1c088026d407","spl_product_data_elements":["Ammonia N 13 AMMONIA N-13 AMMONIA N-13 AMMONIA N-13"],"spl_unclassified_section":["Manufactured by: Kreitchman PET Center, 722 W 168th Street, R-1 Level Room 110, New York, NY 10032 Distributed by: Kreitchman PET Center, 722 W 168th Street, R-1 Level Room 110, New York, NY 10032"],"version":"7"}