{"answer":{"query":"Trazodone HCl","resolved_as":"applications","packages":271,"applications":["ANDA202180","ANDA205253"],"identity":{"application_numbers":["ANDA202180","ANDA205253"],"marketing_categories":["ANDA"],"labelers":[{"text":"AMERICAN HEALTH PACKAGING","untrusted":true}],"dosage_forms":[{"text":"TABLET","untrusted":true}],"marketing_start":{"earliest":"2013-11-27","latest":"2026-10-16","packages_with_a_start_date":271}},"label_history":{"events_total":10,"non_cmc_events":9,"counts_by_class":{"LABELING":9},"cmc_events":1,"recent_non_cmc_events":[{"application":"ANDA205253","submission_no":24,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2025-06-24","documents":[],"fact_id":"3eb18fd33242f1dd498295af"},{"application":"ANDA202180","submission_no":14,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2025-06-24","documents":[],"fact_id":"e4079f2ebe935e4756a27306"},{"application":"ANDA202180","submission_no":11,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2025-06-18","documents":[],"fact_id":"eb501fe43cff2ec4fa4c6608"},{"application":"ANDA202180","submission_no":6,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2025-06-18","documents":[],"fact_id":"f467e6fecdfd7aece7ca0bb2"},{"application":"ANDA205253","submission_no":18,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2022-10-18","documents":[],"fact_id":"91dc6a09dad2697563c8cc1f"}],"note":"a dated list of FDA supplements and their classes, not a reading of what changed in the label"},"substitution":{"products_total":8,"te_code_counts":{"AB":8},"marketing_status_counts":{"Prescription":8},"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":"ANDA202180","product_no":"003","te_code":"AB","marketing_status":"Prescription","drug_name":{"text":"TRAZODONE HYDROCHLORIDE","untrusted":true},"form":{"text":"TABLET;ORAL","untrusted":true},"strength":{"text":"150MG","untrusted":true}},{"application":"ANDA202180","product_no":"001","te_code":"AB","marketing_status":"Prescription","drug_name":{"text":"TRAZODONE HYDROCHLORIDE","untrusted":true},"form":{"text":"TABLET;ORAL","untrusted":true},"strength":{"text":"50MG","untrusted":true}},{"application":"ANDA202180","product_no":"004","te_code":"AB","marketing_status":"Prescription","drug_name":{"text":"TRAZODONE HYDROCHLORIDE","untrusted":true},"form":{"text":"TABLET;ORAL","untrusted":true},"strength":{"text":"300MG","untrusted":true}},{"application":"ANDA202180","product_no":"002","te_code":"AB","marketing_status":"Prescription","drug_name":{"text":"TRAZODONE HYDROCHLORIDE","untrusted":true},"form":{"text":"TABLET;ORAL","untrusted":true},"strength":{"text":"100MG","untrusted":true}},{"application":"ANDA205253","product_no":"002","te_code":"AB","marketing_status":"Prescription","drug_name":{"text":"TRAZODONE HYDROCHLORIDE","untrusted":true},"form":{"text":"TABLET;ORAL","untrusted":true},"strength":{"text":"100MG","untrusted":true}},{"application":"ANDA205253","product_no":"004","te_code":"AB","marketing_status":"Prescription","drug_name":{"text":"TRAZODONE HYDROCHLORIDE","untrusted":true},"form":{"text":"TABLET;ORAL","untrusted":true},"strength":{"text":"300MG","untrusted":true}},{"application":"ANDA205253","product_no":"001","te_code":"AB","marketing_status":"Prescription","drug_name":{"text":"TRAZODONE HYDROCHLORIDE","untrusted":true},"form":{"text":"TABLET;ORAL","untrusted":true},"strength":{"text":"50MG","untrusted":true}},{"application":"ANDA205253","product_no":"003","te_code":"AB","marketing_status":"Prescription","drug_name":{"text":"TRAZODONE HYDROCHLORIDE","untrusted":true},"form":{"text":"TABLET;ORAL","untrusted":true},"strength":{"text":"150MG","untrusted":true}}]},"recalls":{"recalls_total":2,"counts_by_class":{"Class III":1,"Class II":1},"packages_of_these_applications":271,"most_recent":[{"recall_number":"D-0247-2026","classification":"Class III","status":"Ongoing","report_date":"2026-01-07","recall_initiated":"2025-12-19","recalling_firm":{"text":"Zydus Pharmaceuticals (USA) Inc","untrusted":true},"reason":{"text":"Failed Tablet/Capsule Specifications: Product complaint received that some tablets had a dent on the plain side of the tablet surface.","untrusted":true},"packages_named":30,"fact_id":"fb1dc72fdedfa6656de96a90"},{"recall_number":"D-0510-2021","classification":"Class II","status":"Terminated","report_date":"2021-06-02","recall_initiated":"2021-03-15","recalling_firm":{"text":"Cardinal Health Inc.","untrusted":true},"reason":{"text":"CGMP Deviations: Intermittent exposure to temperature excursion during storage.","untrusted":true},"packages_named":1,"fact_id":"3b18096be3bf76d5a079a7b7"}],"meaning":"FDA classifies the health hazard of a recall, not its effect on supply"},"supply":{"fda_shortage_status_counts":{},"packages_with_a_termination_date":1,"next_package_termination_dates":["2027-08-31"],"packages_with_future_termination_date":1,"termination_meaning":"manufacturer-reported last-lot expiry or withdrawal date of one package; other packages and generics can remain"},"assistance_and_offers":{"programs_listing_this_drug":[{"name":{"text":"Mark Cuban Cost Plus Drugs","untrusted":true},"type":"discount","url":"https://costplusdrugs.com/","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":"Trazodone HCl","untrusted":true},"brand":{"text":"Trazodone HCl","untrusted":true}},"latest_year":2024,"series":[{"year":2020,"gross_spending_usd":186017121.18,"claims":14786802,"beneficiaries":3047903,"average_spending_per_claim_usd":12.579942653,"fact_id":"f7807643460943bdaa6964c8"},{"year":2021,"gross_spending_usd":188769191.02,"claims":15157920,"beneficiaries":3225088,"average_spending_per_claim_usd":12.453502263,"fact_id":"44089f001c717f9908e70e9b"},{"year":2022,"gross_spending_usd":201225022.96,"claims":15943026,"beneficiaries":3427020,"average_spending_per_claim_usd":12.621507546,"fact_id":"19eacf32c7674bb2c99cead0"},{"year":2023,"gross_spending_usd":216388379.07,"claims":17040644,"beneficiaries":3666058,"average_spending_per_claim_usd":12.698368622,"fact_id":"7df2d2f0a727edf44e611bfb"},{"year":2024,"gross_spending_usd":165400397.52,"claims":18424765,"beneficiaries":3945008,"average_spending_per_claim_usd":8.9770695865,"fact_id":"603035f55e21814f03094805"}],"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":35,"all_states_medicaid_reimbursed_usd":343188.22,"all_states_medicaid_paid_prescriptions":19366,"top_states":[{"state":"CA","medicaid_paid_prescriptions":5962,"medicaid_reimbursed_usd":99751.97,"total_reimbursed_usd":99819.9,"packages":1,"covers":"fee_for_service_only","fact_id":"a98c2cb35d6fceb17fad13ac"},{"state":"AZ","medicaid_paid_prescriptions":2124,"medicaid_reimbursed_usd":61207.15,"total_reimbursed_usd":66601.99,"packages":2,"covers":"fee_for_service_only","fact_id":"256d333ac3676f757525a4d4"},{"state":"TX","medicaid_paid_prescriptions":486,"medicaid_reimbursed_usd":19566.88,"total_reimbursed_usd":19710.23,"packages":1,"covers":"all_record_types","fact_id":"ebb8cd8a3bf9d6aae14e2827"},{"state":"NH","medicaid_paid_prescriptions":4582,"medicaid_reimbursed_usd":18327.76,"total_reimbursed_usd":18327.76,"packages":4,"covers":"fee_for_service_only","fact_id":"2ff720c54a386f5f7a8ed6b6"},{"state":"MN","medicaid_paid_prescriptions":503,"medicaid_reimbursed_usd":17190.56,"total_reimbursed_usd":17190.56,"packages":3,"covers":"fee_for_service_only","fact_id":"f547f7e9e446cf72ebeeeca2"},{"state":"LA","medicaid_paid_prescriptions":219,"medicaid_reimbursed_usd":15201.99,"total_reimbursed_usd":15289.96,"packages":1,"covers":"all_record_types","fact_id":"a093d21354a57c769336dfe1"},{"state":"OR","medicaid_paid_prescriptions":308,"medicaid_reimbursed_usd":10475.79,"total_reimbursed_usd":10487.78,"packages":1,"covers":"all_record_types","fact_id":"2a4d25ee997f3bda1066b4dd"},{"state":"OH","medicaid_paid_prescriptions":280,"medicaid_reimbursed_usd":9219.24,"total_reimbursed_usd":9308.37,"packages":1,"covers":"fee_for_service_only","fact_id":"18b634ed305bd414f74db0bc"},{"state":"MO","medicaid_paid_prescriptions":206,"medicaid_reimbursed_usd":7697.06,"total_reimbursed_usd":7697.06,"packages":1,"covers":"all_record_types","fact_id":"b425c3e7573fe0fd9eae2987"},{"state":"IN","medicaid_paid_prescriptions":725,"medicaid_reimbursed_usd":7547.55,"total_reimbursed_usd":7547.55,"packages":2,"covers":"fee_for_service_only","fact_id":"cea8be1d8692412ccbb0159b"}],"unlabelled_state_code_xx":null,"built_from_facts":46,"facts_fee_for_service_only":17,"older_year_facts_not_used":775,"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":"3933c6749e808a14287103ca","field":"ndc.listing","entity":"ndc:00904686861"},{"fact_id":"e8f9508ac6433527942ceab1","field":"ndc.listing","entity":"ndc:00904686961"},{"fact_id":"cf7550ffd20a1e76ec97262e","field":"ndc.listing","entity":"ndc:00904721261"},{"fact_id":"3eb18fd33242f1dd498295af","field":"drug.label_event","entity":"application:ANDA205253"},{"fact_id":"e4079f2ebe935e4756a27306","field":"drug.label_event","entity":"application:ANDA202180"},{"fact_id":"eb501fe43cff2ec4fa4c6608","field":"drug.label_event","entity":"application:ANDA202180"},{"fact_id":"f467e6fecdfd7aece7ca0bb2","field":"drug.label_event","entity":"application:ANDA202180"},{"fact_id":"91dc6a09dad2697563c8cc1f","field":"drug.label_event","entity":"application:ANDA205253"},{"fact_id":"b7f8398ddd95c48ece58e177","field":"drug.te_code","entity":"application:ANDA202180"},{"fact_id":"ce8b3d7853e7695172b11ddf","field":"drug.marketing_status","entity":"application:ANDA202180"},{"fact_id":"a61c2c2969ab8d5d506e1a25","field":"drug.te_code","entity":"application:ANDA202180"},{"fact_id":"159488498a72fd365d83ef2d","field":"drug.marketing_status","entity":"application:ANDA202180"},{"fact_id":"6b52d004f6b707e20597a6f7","field":"drug.te_code","entity":"application:ANDA202180"},{"fact_id":"9de8a98ca38338c48b99a52a","field":"drug.marketing_status","entity":"application:ANDA202180"},{"fact_id":"297cb7b27c03b38a27406df0","field":"drug.te_code","entity":"application:ANDA202180"},{"fact_id":"d0a469ae6231cd20b8762336","field":"drug.marketing_status","entity":"application:ANDA202180"},{"fact_id":"a75964184c30c28772ccb207","field":"drug.te_code","entity":"application:ANDA205253"},{"fact_id":"afcdea30874d60ba281352cf","field":"drug.marketing_status","entity":"application:ANDA205253"},{"fact_id":"a57aae240b3a1c2a1adcf6fb","field":"drug.te_code","entity":"application:ANDA205253"},{"fact_id":"c46709ef4a11064e02ad77c0","field":"drug.marketing_status","entity":"application:ANDA205253"},{"fact_id":"5577bef5377f1a1cac83ac68","field":"drug.te_code","entity":"application:ANDA205253"},{"fact_id":"2afe92f4a8d095054f6f901b","field":"drug.marketing_status","entity":"application:ANDA205253"},{"fact_id":"2f335381a3ba9624dcc80859","field":"drug.te_code","entity":"application:ANDA205253"},{"fact_id":"b0da776c643732199f64f20e","field":"drug.marketing_status","entity":"application:ANDA205253"},{"fact_id":"fb1dc72fdedfa6656de96a90","field":"ndc.recall","entity":"ndc:68382080506"},{"fact_id":"3b18096be3bf76d5a079a7b7","field":"ndc.recall","entity":"ndc:00904686861"},{"fact_id":"3026b5c309652da8ed741d22","field":"ndc.product","entity":"ndc:60687044301"},{"fact_id":"f7807643460943bdaa6964c8","field":"drug.partd_spending","entity":"drug:trazodone-hcl|trazodone-hcl"},{"fact_id":"44089f001c717f9908e70e9b","field":"drug.partd_spending","entity":"drug:trazodone-hcl|trazodone-hcl"},{"fact_id":"19eacf32c7674bb2c99cead0","field":"drug.partd_spending","entity":"drug:trazodone-hcl|trazodone-hcl"},{"fact_id":"7df2d2f0a727edf44e611bfb","field":"drug.partd_spending","entity":"drug:trazodone-hcl|trazodone-hcl"},{"fact_id":"603035f55e21814f03094805","field":"drug.partd_spending","entity":"drug:trazodone-hcl|trazodone-hcl"},{"fact_id":"a98c2cb35d6fceb17fad13ac","field":"ndc.medicaid_state_utilization","entity":"ndc_state:13668033205:CA"},{"fact_id":"256d333ac3676f757525a4d4","field":"ndc.medicaid_state_utilization","entity":"ndc_state:68382080801:AZ"},{"fact_id":"ebb8cd8a3bf9d6aae14e2827","field":"ndc.medicaid_state_utilization","entity":"ndc_state:68382080801:TX"},{"fact_id":"2ff720c54a386f5f7a8ed6b6","field":"ndc.medicaid_state_utilization","entity":"ndc_state:13668033001:NH"},{"fact_id":"f547f7e9e446cf72ebeeeca2","field":"ndc.medicaid_state_utilization","entity":"ndc_state:68382080801:MN"},{"fact_id":"a093d21354a57c769336dfe1","field":"ndc.medicaid_state_utilization","entity":"ndc_state:68382080801:LA"},{"fact_id":"2a4d25ee997f3bda1066b4dd","field":"ndc.medicaid_state_utilization","entity":"ndc_state:68382080801:OR"},{"fact_id":"18b634ed305bd414f74db0bc","field":"ndc.medicaid_state_utilization","entity":"ndc_state:68382080801:OH"},{"fact_id":"b425c3e7573fe0fd9eae2987","field":"ndc.medicaid_state_utilization","entity":"ndc_state:68382080801:MO"},{"fact_id":"cea8be1d8692412ccbb0159b","field":"ndc.medicaid_state_utilization","entity":"ndc_state:68382080801:IN"}],"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:ANDA202180","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:ANDA205253","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":"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."}