{"answer":{"query":"Wixela Inhub","resolved_as":"applications","packages":4,"applications":["ANDA208891"],"identity":{"application_numbers":["ANDA208891"],"marketing_categories":["ANDA"],"labelers":[],"dosage_forms":[{"text":"POWDER","untrusted":true}],"marketing_start":{"earliest":"2019-02-11","latest":"2025-02-13","packages_with_a_start_date":4}},"label_history":{"events_total":1,"non_cmc_events":1,"counts_by_class":{"LABELING":1},"cmc_events":0,"recent_non_cmc_events":[{"application":"ANDA208891","submission_no":9,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2022-03-31","documents":[],"fact_id":"d78576ae86cf683aa1140fda"}],"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":{"AB":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":"ANDA208891","product_no":"001","te_code":"AB","marketing_status":"Prescription","drug_name":{"text":"WIXELA INHUB","untrusted":true},"form":{"text":"POWDER;INHALATION","untrusted":true},"strength":{"text":"0.1MG/INH;EQ 0.05MG BASE/INH","untrusted":true}},{"application":"ANDA208891","product_no":"002","te_code":"AB","marketing_status":"Prescription","drug_name":{"text":"WIXELA INHUB","untrusted":true},"form":{"text":"POWDER;INHALATION","untrusted":true},"strength":{"text":"0.25MG/INH;EQ 0.05MG BASE/INH","untrusted":true}},{"application":"ANDA208891","product_no":"003","te_code":"AB","marketing_status":"Prescription","drug_name":{"text":"WIXELA INHUB","untrusted":true},"form":{"text":"POWDER;INHALATION","untrusted":true},"strength":{"text":"0.5MG/INH;EQ 0.05MG BASE/INH","untrusted":true}}]},"recalls":{"recalls_total":1,"counts_by_class":{"Class II":1},"packages_of_these_applications":4,"most_recent":[{"recall_number":"D-0202-2024","classification":"Class II","status":"Terminated","report_date":"2024-01-03","recall_initiated":"2022-01-26","recalling_firm":{"text":"CARDINAL HEALTHCARE","untrusted":true},"reason":{"text":"CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.","untrusted":true},"packages_named":3,"fact_id":"fa9ff0c060a8c99c10349fe3"}],"meaning":"FDA classifies the health hazard of a recall, not its effect on supply"},"assistance_and_offers":{"programs_listing_this_drug":[{"name":{"text":"GSK Patient Assistance Program","untrusted":true},"type":"manufacturer","url":"https://www.gskpaf.org/","status":null,"needs_status_check":false,"has_offer":false}],"manufacturer_offers":[],"note":"A program that lists a drug has not decided anything about any person: each program decides who qualifies, and a status other than open means it may not take new patients. Offers change and expire; read each offer's source and stated end date. A price figure is what the page states, not a quote."},"spending":{"reported_under":{"generic":{"text":"Fluticasone Propion/Salmeterol","untrusted":true},"brand":{"text":"Wixela Inhub","untrusted":true}},"latest_year":2024,"series":[{"year":2020,"gross_spending_usd":336782717.86,"claims":1133759,"beneficiaries":371599,"average_spending_per_claim_usd":297.04965329,"fact_id":"9938da6fe1bf0f8ae94ffe15"},{"year":2021,"gross_spending_usd":366928382.18,"claims":1249010,"beneficiaries":401682,"average_spending_per_claim_usd":293.77537584,"fact_id":"d657b757fba83b07a97d4821"},{"year":2022,"gross_spending_usd":326812318.5,"claims":1094388,"beneficiaries":352093,"average_spending_per_claim_usd":298.62564145,"fact_id":"4d35835b2ad84671ca7fc002"},{"year":2023,"gross_spending_usd":272994335.06,"claims":957338,"beneficiaries":320592,"average_spending_per_claim_usd":285.15982345,"fact_id":"2f28aa26faa9077349a3801c"},{"year":2024,"gross_spending_usd":196500762.92,"claims":1281804,"beneficiaries":446733,"average_spending_per_claim_usd":153.30016361,"fact_id":"e8f22719612bd10d6cd564cb"}],"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}}},"medicaid_state_utilization":{"year":2025,"states_with_data":6,"all_states_medicaid_reimbursed_usd":391191.56,"all_states_medicaid_paid_prescriptions":3566,"top_states":[{"state":"OK","medicaid_paid_prescriptions":3229,"medicaid_reimbursed_usd":369989.13,"total_reimbursed_usd":381724.3,"packages":3,"covers":"all_record_types","fact_id":"6db551c1e2b9e6dabb69682d"},{"state":"CO","medicaid_paid_prescriptions":90,"medicaid_reimbursed_usd":8712.1,"total_reimbursed_usd":8736.65,"packages":1,"covers":"fee_for_service_only","fact_id":"ee43aae45f89197f16cb25af"},{"state":"FL","medicaid_paid_prescriptions":53,"medicaid_reimbursed_usd":6252,"total_reimbursed_usd":6482.13,"packages":1,"covers":"all_record_types","fact_id":"48ff7f643b461978e525a41f"},{"state":"IA","medicaid_paid_prescriptions":62,"medicaid_reimbursed_usd":3352.33,"total_reimbursed_usd":3352.33,"packages":1,"covers":"all_record_types","fact_id":"b20b2a65c8c1ebb91b1df808"},{"state":"WA","medicaid_paid_prescriptions":78,"medicaid_reimbursed_usd":1471.91,"total_reimbursed_usd":5013.66,"packages":1,"covers":"all_record_types","fact_id":"0c8c4e4a16b14cdc6b764552"},{"state":"MO","medicaid_paid_prescriptions":54,"medicaid_reimbursed_usd":1414.09,"total_reimbursed_usd":2426.46,"packages":1,"covers":"all_record_types","fact_id":"9046ce09070f16a74c10caef"}],"unlabelled_state_code_xx":null,"built_from_facts":8,"facts_fee_for_service_only":1,"older_year_facts_not_used":103,"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":"1e323e325e431310803406d9","field":"ndc.listing","entity":"ndc:00378932032"},{"fact_id":"bc9a9f8dd0f897db8b869f12","field":"ndc.listing","entity":"ndc:00378932132"},{"fact_id":"ef3d838edeb2ad9feb6c562c","field":"ndc.listing","entity":"ndc:00378932232"},{"fact_id":"d78576ae86cf683aa1140fda","field":"drug.label_event","entity":"application:ANDA208891"},{"fact_id":"9a44dd9c6e562501360b3298","field":"drug.te_code","entity":"application:ANDA208891"},{"fact_id":"80cc437b97537ed280dae415","field":"drug.marketing_status","entity":"application:ANDA208891"},{"fact_id":"994abf7914f16ad5e7ba12c8","field":"drug.te_code","entity":"application:ANDA208891"},{"fact_id":"3416d2129182dc9ff4cc0b48","field":"drug.marketing_status","entity":"application:ANDA208891"},{"fact_id":"678c6b665eb1173f6e30b002","field":"drug.te_code","entity":"application:ANDA208891"},{"fact_id":"02d647bc7d6c553fb9c24fec","field":"drug.marketing_status","entity":"application:ANDA208891"},{"fact_id":"fa9ff0c060a8c99c10349fe3","field":"ndc.recall","entity":"ndc:00378932232"},{"fact_id":"9938da6fe1bf0f8ae94ffe15","field":"drug.partd_spending","entity":"drug:fluticasone-propion-salmeterol|wixela-inhub"},{"fact_id":"d657b757fba83b07a97d4821","field":"drug.partd_spending","entity":"drug:fluticasone-propion-salmeterol|wixela-inhub"},{"fact_id":"4d35835b2ad84671ca7fc002","field":"drug.partd_spending","entity":"drug:fluticasone-propion-salmeterol|wixela-inhub"},{"fact_id":"2f28aa26faa9077349a3801c","field":"drug.partd_spending","entity":"drug:fluticasone-propion-salmeterol|wixela-inhub"},{"fact_id":"e8f22719612bd10d6cd564cb","field":"drug.partd_spending","entity":"drug:fluticasone-propion-salmeterol|wixela-inhub"},{"fact_id":"6db551c1e2b9e6dabb69682d","field":"ndc.medicaid_state_utilization","entity":"ndc_state:00378932132:OK"},{"fact_id":"ee43aae45f89197f16cb25af","field":"ndc.medicaid_state_utilization","entity":"ndc_state:00378932132:CO"},{"fact_id":"48ff7f643b461978e525a41f","field":"ndc.medicaid_state_utilization","entity":"ndc_state:00378932032:FL"},{"fact_id":"b20b2a65c8c1ebb91b1df808","field":"ndc.medicaid_state_utilization","entity":"ndc_state:00378932032:IA"},{"fact_id":"0c8c4e4a16b14cdc6b764552","field":"ndc.medicaid_state_utilization","entity":"ndc_state:00378932032:WA"},{"fact_id":"9046ce09070f16a74c10caef","field":"ndc.medicaid_state_utilization","entity":"ndc_state:00378932032:MO"}],"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:ANDA208891","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":"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":"AMBIGUOUS","field":"spending","reason":"2 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":"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."}