{"answer":{"query":"ofev","resolved_as":"name","packages":2,"applications":["NDA205832"],"identity":{"application_numbers":["NDA205832"],"marketing_categories":["NDA"],"labelers":[{"text":"BOEHRINGER INGELHEIM PHARMACEUTICALS","untrusted":true}],"dosage_forms":[{"text":"CAPSULE","untrusted":true}],"marketing_start":{"earliest":"2014-10-17","latest":"2014-10-17","packages_with_a_start_date":2}},"price":{"median_negotiated_over_nadac":null,"packages_compared":0,"packages_listed":2,"negotiated_price_ends":null,"rows":[{"ndc":"00597014360","name":{"text":"Ofev (nintedanib) 100mg","untrusted":true},"class":null,"nadac_per_unit":null,"negotiated_per_unit":null,"ratio":null,"ful_per_unit":null},{"ndc":"00597014560","name":{"text":"Ofev (nintedanib) 150mg","untrusted":true},"class":null,"nadac_per_unit":null,"negotiated_per_unit":null,"ratio":null,"ful_per_unit":null}],"negotiated_scheduled":{"thirty_day":6350,"effective":"2027-01-01"}},"generic_entry":[{"application":"NDA205832","date":"2029-12-07","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":"assistance_and_offers","reason":"no assistance program lists this drug and no manufacturer offer naming it is recorded; that does not mean none exists"},{"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":"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."}