{"answer":{"query":"Dulera","resolved_as":"applications","packages":5,"applications":["NDA022518"],"identity":{"application_numbers":["NDA022518"],"marketing_categories":["NDA"],"labelers":[],"dosage_forms":[{"text":"AEROSOL","untrusted":true}],"marketing_start":{"earliest":"2021-06-01","latest":"2021-06-01","packages_with_a_start_date":5}},"label_history":{"events_total":24,"non_cmc_events":18,"counts_by_class":{"EFFICACY":3,"LABELING":14,"REMS":1},"cmc_events":6,"recent_non_cmc_events":[{"application":"NDA022518","submission_no":26,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2019-08-12","documents":[{"type":"Letter","date":"2019-08-13","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022518Orig1s026ltr.pdf","untrusted":true}},{"type":"Label","date":"2019-08-13","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022518s026lbl.pdf","untrusted":true}}],"fact_id":"0e8ece08a3856cd3704802f2"},{"application":"NDA022518","submission_no":24,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2018-03-23","documents":[{"type":"Label","date":"2018-03-27","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022518s024lbl.pdf","untrusted":true}},{"type":"Letter","date":"2018-03-29","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022518Orig1s023s024ltr.pdf","untrusted":true}}],"fact_id":"0fc94f5a0ea3614ed9134fad"},{"application":"NDA022518","submission_no":23,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2018-03-23","documents":[{"type":"Label","date":"2018-03-27","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022518s023s024lbl.pdf","untrusted":true}},{"type":"Letter","date":"2018-03-29","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022518Orig1s023s024ltr.pdf","untrusted":true}}],"fact_id":"f0cbb1ddff9f5d352a82b38c"},{"application":"NDA022518","submission_no":22,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2017-12-20","documents":[{"type":"Label","date":"2017-12-22","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022518s022lbl.pdf","untrusted":true}},{"type":"Letter","date":"2017-12-27","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022518Orig1s022ltr.pdf","untrusted":true}}],"fact_id":"a4e139d44f1eb748c3fd7e10"},{"application":"NDA022518","submission_no":21,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2017-06-27","documents":[{"type":"Label","date":"2017-06-28","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022518s021lbl.pdf","untrusted":true}},{"type":"Letter","date":"2017-06-29","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022518Orig1s021ltr.pdf","untrusted":true}}],"fact_id":"9edbeb4bc4a0cbb1b2fe1f8d"}],"note":"a dated list of FDA supplements and their classes, not a reading of what changed in the label"},"substitution":{"products_total":3,"te_code_counts":{"NOT_PROVIDED":3},"marketing_status_counts":{"Prescription":3},"meaning":"raw FDA codes; the therapeutic equivalence code says whether FDA rates a generic as substitutable, and what that means for a given prescription is for a pharmacist or prescriber","products":[{"application":"NDA022518","product_no":"002","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"DULERA","untrusted":true},"form":{"text":"AEROSOL, METERED;INHALATION","untrusted":true},"strength":{"text":"0.005MG/INH;0.2MG/INH","untrusted":true}},{"application":"NDA022518","product_no":"003","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"DULERA","untrusted":true},"form":{"text":"AEROSOL, METERED;INHALATION","untrusted":true},"strength":{"text":"0.005MG/INH;0.05MG/INH","untrusted":true}},{"application":"NDA022518","product_no":"001","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"DULERA","untrusted":true},"form":{"text":"AEROSOL, METERED;INHALATION","untrusted":true},"strength":{"text":"0.005MG/INH;0.1MG/INH","untrusted":true}}]},"spending":{"reported_under":{"generic":{"text":"Mometasone/Formoterol","untrusted":true},"brand":{"text":"Dulera","untrusted":true}},"latest_year":2024,"series":[{"year":2021,"gross_spending_usd":13587322.59,"claims":28932,"beneficiaries":76849,"average_spending_per_claim_usd":469.62956553,"fact_id":"12a8f3f8bc1e82ed5c883a62"},{"year":2022,"gross_spending_usd":100804524.99,"claims":225957,"beneficiaries":65284,"average_spending_per_claim_usd":446.12260293,"fact_id":"0d468255113285fc49b50d5e"},{"year":2023,"gross_spending_usd":116998630.84,"claims":252491,"beneficiaries":70485,"average_spending_per_claim_usd":463.37743064,"fact_id":"d5b3fd977a5aaa71bce40fa7"},{"year":2024,"gross_spending_usd":162082132.71,"claims":369910,"beneficiaries":105783,"average_spending_per_claim_usd":438.16639915,"fact_id":"ab76acc37edabe454e45956d"}],"rebate_caveat":"CMS's dataset states spending is gross drug cost and does not reflect manufacturers' rebates or other price concessions.","not_a_patient_price":"Spending is the total paid by Medicare, plans and beneficiaries for the drug's claims, not what a patient pays.","meaning":"a drug-level aggregate of Medicare Part D claims for all manufacturers combined; not a formulary, not coverage","source":{"dataset":{"text":"data-year-2024, modified 2026-06-25","untrusted":true},"link":{"text":"https://data.cms.gov/summary-statistics-on-use-and-payments/medicare-medicaid-spending-by-drug/medicare-part-d-spending-by-drug","untrusted":true}}},"rems":{"programs":[{"application":"NDA022518","program":{"text":"Dulera","untrusted":true},"rems_id":"178","in_force":false,"released":true,"moved_to_shared_system":false,"has_etasu":false,"program_date":"2010-06-22","last_modified":"2012-11-27","source_page":"https://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=178","other_programs":0,"read_on":"2026-11-07T20:05:28.959Z","fact_id":"4cd5d091fcbb26a8c2f36624"}],"reading":"what the FDA REMS@FDA files tie to the application on the read date; it does not say which prescribers or pharmacies take part or whether a patient needs the program"},"medicaid_state_utilization":{"year":2025,"states_with_data":4,"all_states_medicaid_reimbursed_usd":146055.93,"all_states_medicaid_paid_prescriptions":416,"top_states":[{"state":"ND","medicaid_paid_prescriptions":174,"medicaid_reimbursed_usd":64868.89,"total_reimbursed_usd":66069.03,"packages":1,"covers":"all_record_types","fact_id":"4dedcaaf15828b3e480c492d"},{"state":"AR","medicaid_paid_prescriptions":86,"medicaid_reimbursed_usd":29777.28,"total_reimbursed_usd":29777.28,"packages":1,"covers":"fee_for_service_only","fact_id":"3b2ed25c490fedffbba010cf"},{"state":"VT","medicaid_paid_prescriptions":57,"medicaid_reimbursed_usd":28171.37,"total_reimbursed_usd":28171.37,"packages":1,"covers":"all_record_types","fact_id":"eec11390b9de3f641ea44a07"},{"state":"SC","medicaid_paid_prescriptions":99,"medicaid_reimbursed_usd":23238.39,"total_reimbursed_usd":23238.39,"packages":1,"covers":"fee_for_service_only","fact_id":"ba0a6e4aa5313b761d73ea28"}],"unlabelled_state_code_xx":null,"built_from_facts":4,"facts_fee_for_service_only":2,"older_year_facts_not_used":194,"dataset":"State Drug Utilization Data 2025","read_on":"2026-11-07T22:41:44.201Z","reading":"Medicaid prescriptions and reimbursement by state (CMS State Drug Utilization Data). Reimbursement is before manufacturer rebates: not a net cost, not a patient price. Suppressed managed-care cells make a state figure fee-for-service only. An absent state was suppressed or unreported, not zero.","receipts_note":"a receipt is held for the largest fact behind each state shown; every figure is a sum of the built_from_facts facts, each recomputable from its recorded input hash"}},"receipts":[{"fact_id":"2e3f0965218f0b1126393222","field":"ndc.listing","entity":"ndc:78206012501"},{"fact_id":"116585a58ee682953f68fdb4","field":"ndc.listing","entity":"ndc:78206012601"},{"fact_id":"6c7aa5fc247b90d1e0d4d83c","field":"ndc.listing","entity":"ndc:78206012602"},{"fact_id":"0e8ece08a3856cd3704802f2","field":"drug.label_event","entity":"application:NDA022518"},{"fact_id":"0fc94f5a0ea3614ed9134fad","field":"drug.label_event","entity":"application:NDA022518"},{"fact_id":"f0cbb1ddff9f5d352a82b38c","field":"drug.label_event","entity":"application:NDA022518"},{"fact_id":"a4e139d44f1eb748c3fd7e10","field":"drug.label_event","entity":"application:NDA022518"},{"fact_id":"9edbeb4bc4a0cbb1b2fe1f8d","field":"drug.label_event","entity":"application:NDA022518"},{"fact_id":"f00f4432865d66918fd3305b","field":"drug.marketing_status","entity":"application:NDA022518"},{"fact_id":"64206c8f1a91d35fc555b4ee","field":"drug.marketing_status","entity":"application:NDA022518"},{"fact_id":"096f3d39f76ce3d49b910e57","field":"drug.marketing_status","entity":"application:NDA022518"},{"fact_id":"12a8f3f8bc1e82ed5c883a62","field":"drug.partd_spending","entity":"drug:mometasone-formoterol|dulera"},{"fact_id":"0d468255113285fc49b50d5e","field":"drug.partd_spending","entity":"drug:mometasone-formoterol|dulera"},{"fact_id":"d5b3fd977a5aaa71bce40fa7","field":"drug.partd_spending","entity":"drug:mometasone-formoterol|dulera"},{"fact_id":"ab76acc37edabe454e45956d","field":"drug.partd_spending","entity":"drug:mometasone-formoterol|dulera"},{"fact_id":"4cd5d091fcbb26a8c2f36624","field":"drug.rems","entity":"application:NDA022518"},{"fact_id":"4dedcaaf15828b3e480c492d","field":"ndc.medicaid_state_utilization","entity":"ndc_state:78206012501:ND"},{"fact_id":"3b2ed25c490fedffbba010cf","field":"ndc.medicaid_state_utilization","entity":"ndc_state:78206012501:AR"},{"fact_id":"eec11390b9de3f641ea44a07","field":"ndc.medicaid_state_utilization","entity":"ndc_state:78206012501:VT"},{"fact_id":"ba0a6e4aa5313b761d73ea28","field":"ndc.medicaid_state_utilization","entity":"ndc_state:78206012602:SC"}],"as_of":{"newest_fact_retrieved_at":"2026-11-10T20:02:39.475Z"},"edition":{"id":"2026-11","merkleRoot":"006ab9a329709cbe7f56a0e1a7c4a02f897655cdfecf9ca34d199690095adcb6","factCount":212100,"manifestPresent":true},"licence":{"classes":["GREEN"],"note":"Source records are public; this compilation is cited with attribution. See the provenance tool for each fact's licence label."},"unknown":[{"code":"NO_DATA","field":"price","reason":"no NADAC price, negotiated price or federal upper limit for these packages"},{"code":"NO_DATA","field":"generic_entry:NDA022518","reason":"no generic-entry fact for this application: no patent or exclusivity is listed for it in the Orange Book edition read, so no date is stated"},{"code":"NO_DATA","field":"generic_entry","reason":"no application of this drug has a generic-entry fact; no date is stated"},{"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":"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":"AMBIGUOUS","field":"spending","reason":"3 brand and generic name pairs match; the series shown is the one with the newest year and the largest spending"},{"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":"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."}