{"effective_time":"20251117","id":"43cf238d-8612-2acf-e063-6294a90a148e","openfda":{"application_number":["NDA205849"],"brand_name":["Oxygen"],"generic_name":["OXYGEN"],"is_original_packager":[true],"manufacturer_name":["Roberts Oxygen Company, Inc."],"package_ndc":["46123-045-01"],"product_ndc":["46123-045"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["RESPIRATORY (INHALATION)"],"rxcui":["312172"],"spl_id":["43cf238d-8612-2acf-e063-6294a90a148e"],"spl_set_id":["c2b0f2bd-2ce2-4096-8aae-07d2200a015b"],"substance_name":["OXYGEN"],"unii":["S88TT14065"]},"package_label_principal_display_panel":["ROBERTS OXYGEN ROCKVILLE, MARYLAND 20866 TEL: (301) 948-8100 CERTIFICATE OF ANALYSIS OXYGEN REFRIGERATED LIQUID, USP* PRODUCED BY AIR-LIQUEFACTION PROCESS TRAILER#: ______________ DATE: _________________ LOT#: _________________ *USP applies only when used in a medical application or by medical customers properly registered with the FDA. Component Test Method Limit Result Oxygen ______ >99.5% _______ Odor ORGANOLEPTIC N/D ______ ________ _________ _________ _________ Product is identified as OXYGEN, USP 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 label"],"set_id":"c2b0f2bd-2ce2-4096-8aae-07d2200a015b","spl_product_data_elements":["Oxygen Oxygen OXYGEN OXYGEN"],"version":"9"}