{"answer":{"query":"breo ellipta","resolved_as":"name","packages":7,"applications":["NDA204275"],"identity":{"application_numbers":["NDA204275"],"marketing_categories":["NDA","NDA AUTHORIZED GENERIC"],"labelers":[{"text":"GLAXOSMITHKLINE","untrusted":true},{"text":"PRASCO LABORATORIES","untrusted":true}],"dosage_forms":[{"text":"POWDER","untrusted":true}],"marketing_start":{"earliest":"2013-08-26","latest":"2023-05-12","packages_with_a_start_date":7}},"price":{"median_negotiated_over_nadac":null,"packages_compared":0,"packages_listed":7,"negotiated_price_ends":null,"rows":[{"ndc":"00173085910","name":{"text":"BREO ELLIPTA 100/25 MCG INHPWDR 30 DS NDPI TRD PACK X 1","untrusted":true},"class":"B","nadac_per_unit":6.49819,"negotiated_per_unit":null,"ratio":null,"ful_per_unit":null},{"ndc":"00173085914","name":{"text":"BREO ELLIPTA 100/25 MCG INHPWDR 14 DOSE NDPI INST PAC X 1","untrusted":true},"class":"B","nadac_per_unit":5.3604,"negotiated_per_unit":null,"ratio":null,"ful_per_unit":null},{"ndc":"00173088210","name":{"text":"BREO ELLIPTA 200/25 MCG INHPWDR 1X 30D","untrusted":true},"class":"B","nadac_per_unit":6.50023,"negotiated_per_unit":null,"ratio":null,"ful_per_unit":null},{"ndc":"00173088214","name":{"text":"BREO ELLIPTA 200/25 MCG INHPWDR 1X 14D INST","untrusted":true},"class":"B","nadac_per_unit":5.3506,"negotiated_per_unit":null,"ratio":null,"ful_per_unit":null},{"ndc":"00173091610","name":{"text":"BREO ELLIPTA 50/25MCG INH PWDR","untrusted":true},"class":"B","nadac_per_unit":6.48077,"negotiated_per_unit":null,"ratio":null,"ful_per_unit":null},{"ndc":"66993013597","name":{"text":"Fluticasone Furoate/Vilanterol","untrusted":true},"class":"G","nadac_per_unit":3.82283,"negotiated_per_unit":null,"ratio":null,"ful_per_unit":null},{"ndc":"66993013697","name":{"text":"Fluticasone Furoate/Vilanterol","untrusted":true},"class":"G","nadac_per_unit":3.88971,"negotiated_per_unit":null,"ratio":null,"ful_per_unit":null}],"negotiated_scheduled":{"thirty_day":67,"effective":"2027-01-01"}},"generic_entry":[{"application":"NDA204275","date":"2031-04-11","reading":"upper bound from listed dates, not a forecast","basis":"latest of all listed patent and exclusivity expiries in this Orange Book edition; 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See the provenance tool for each fact's licence label."},"unknown":[{"code":"NO_DATA","field":"price.ratio","reason":"no package has both a brand-class NADAC price and a negotiated price in force"},{"code":"NO_DATA","field":"recalls","reason":"no FDA enforcement report naming a package of these applications is recorded"},{"code":"NO_DATA","field":"supply","reason":"no FDA shortage row and no termination date for these packages"},{"code":"NO_DATA","field":"trials","reason":"no ClinicalTrials.gov record set for this drug's ingredient is in the edition"},{"code":"NO_DATA","field":"policy","reason":"no Federal Register event in the edition names this drug or its programs"},{"code":"NO_DATA","field":"biologic_status","reason":"no biologic application of this drug has a Purple Book status in the edition (a drug that is not a biologic has none)"},{"code":"NO_DATA","field":"payment_limit","reason":"no HCPCS code whose NDC crosswalk names a package of these applications has a Part B payment limit in the edition"},{"code":"NO_DATA","field":"rems","reason":"no REMS@FDA program is tied to these applications in the edition (most drugs have none)"},{"code":"NO_DATA","field":"controlled_schedule","reason":"no DEA schedule entry matched this drug's ingredient in the edition"},{"code":"NO_DATA","field":"orphan_designation","reason":"no FDA orphan designation for this drug's ingredient is in the edition"},{"code":"NO_DATA","field":"safety_communication","reason":"no FDA Drug Safety Communication names this drug's ingredient in the edition"}],"disclaimer":"OmniRx is a reference layer of dated public facts, not clinical advice and not a guarantee of price, coverage or eligibility. Each answer lists the facts it rests on."}