{"effective_time":"20251117","id":"43ced637-115d-0659-e063-6394a90a6810","openfda":{"application_number":["NDA205850"],"brand_name":["Nitrogen"],"generic_name":["NITROGEN"],"is_original_packager":[true],"manufacturer_name":["Roberts Oxygen Company, Inc."],"package_ndc":["46123-440-01"],"product_ndc":["46123-440"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["RESPIRATORY (INHALATION)"],"rxcui":["311998"],"spl_id":["43ced637-115d-0659-e063-6394a90a6810"],"spl_set_id":["2bed6bd8-086e-ee30-e063-6394a90ad420"],"substance_name":["NITROGEN"],"unii":["N762921K75"]},"package_label_principal_display_panel":["ROBERTS OXYGEN ROCKVILLE, MARYLAND 20866 TEL: (301) 948-8100 CERTIFICATE OF ANALYSIS NITROGEN REFRIGERATED LIQUID, NF* PRODUCED BY AIR-LIQUEFACTION PROCESS TRAILER#: ______________ DATE: _________________ LOT#: _________________ *NF applies only when used in a medical application or by medical customers properly registered with the FDA. Component Test Method Limit Result NITROGEN DIFF > 99.999% _______ OXYGEN ________ <3.0 PPM _______ Odor ORGANOLEPTIC N/D ______ ________ _________ _________ _________ Product is identified as NITROGEN, NF through process validations, dedicated piping, and product specific connections. Notes: _____________________________________ RELEASED BY: ____________________________ SIGNATURE RELEASED BY: ____________________________ PRINTED NAME Printed & Published by J.J. KELLER & ASSPCIATES, INC., Neenah, WI * USP (800) 327-6868 *jjkeller.com * Printer in the Unitied States image description"],"set_id":"2bed6bd8-086e-ee30-e063-6394a90ad420","spl_product_data_elements":["Nitrogen Nitrogen NITROGEN NITROGEN"],"version":"2"}