{"answer":{"query":"Venlafaxine HCl ER","resolved_as":"applications","packages":183,"applications":["ANDA200834","ANDA212277"],"identity":{"application_numbers":["ANDA200834","ANDA212277"],"marketing_categories":["ANDA"],"labelers":[],"dosage_forms":[{"text":"CAPSULE, EXTENDED RELEASE","untrusted":true}],"marketing_start":{"earliest":"2011-06-01","latest":"2026-11-02","packages_with_a_start_date":183}},"label_history":{"events_total":18,"non_cmc_events":18,"counts_by_class":{"LABELING":18},"cmc_events":0,"recent_non_cmc_events":[{"application":"ANDA212277","submission_no":5,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2024-03-19","documents":[],"fact_id":"82792cc467e345fb4c7f98de"},{"application":"ANDA212277","submission_no":3,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2024-03-19","documents":[],"fact_id":"356aa416827c3a19c7ce8d9a"},{"application":"ANDA212277","submission_no":2,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2024-03-19","documents":[],"fact_id":"91df2b4baac32d1032f12092"},{"application":"ANDA200834","submission_no":29,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2024-01-03","documents":[],"fact_id":"029e0000c1e4e8c9d3430604"},{"application":"ANDA200834","submission_no":26,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2023-03-30","documents":[],"fact_id":"99fbfa6d9021489f94becdbc"}],"note":"a dated list of FDA supplements and their classes, not a reading of what changed in the label"},"substitution":{"products_total":6,"te_code_counts":{"AB":6},"marketing_status_counts":{"Prescription":6},"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":"ANDA200834","product_no":"003","te_code":"AB","marketing_status":"Prescription","drug_name":{"text":"VENLAFAXINE HYDROCHLORIDE","untrusted":true},"form":{"text":"CAPSULE, EXTENDED RELEASE;ORAL","untrusted":true},"strength":{"text":"EQ 150MG BASE","untrusted":true}},{"application":"ANDA200834","product_no":"002","te_code":"AB","marketing_status":"Prescription","drug_name":{"text":"VENLAFAXINE HYDROCHLORIDE","untrusted":true},"form":{"text":"CAPSULE, EXTENDED RELEASE;ORAL","untrusted":true},"strength":{"text":"EQ 75MG BASE","untrusted":true}},{"application":"ANDA200834","product_no":"001","te_code":"AB","marketing_status":"Prescription","drug_name":{"text":"VENLAFAXINE HYDROCHLORIDE","untrusted":true},"form":{"text":"CAPSULE, EXTENDED RELEASE;ORAL","untrusted":true},"strength":{"text":"EQ 37.5MG BASE","untrusted":true}},{"application":"ANDA212277","product_no":"002","te_code":"AB","marketing_status":"Prescription","drug_name":{"text":"VENLAFAXINE HYDROCHLORIDE","untrusted":true},"form":{"text":"CAPSULE, EXTENDED RELEASE;ORAL","untrusted":true},"strength":{"text":"EQ 75MG BASE","untrusted":true}},{"application":"ANDA212277","product_no":"003","te_code":"AB","marketing_status":"Prescription","drug_name":{"text":"VENLAFAXINE HYDROCHLORIDE","untrusted":true},"form":{"text":"CAPSULE, EXTENDED RELEASE;ORAL","untrusted":true},"strength":{"text":"EQ 150MG BASE","untrusted":true}},{"application":"ANDA212277","product_no":"001","te_code":"AB","marketing_status":"Prescription","drug_name":{"text":"VENLAFAXINE HYDROCHLORIDE","untrusted":true},"form":{"text":"CAPSULE, EXTENDED RELEASE;ORAL","untrusted":true},"strength":{"text":"EQ 37.5MG BASE","untrusted":true}}]},"recalls":{"recalls_total":1,"counts_by_class":{"Class II":1},"packages_of_these_applications":183,"most_recent":[{"recall_number":"D-0474-2017","classification":"Class II","status":"Terminated","report_date":"2017-02-22","recall_initiated":"2016-12-22","recalling_firm":{"text":"Aurobindo Pharma USA Inc","untrusted":true},"reason":{"text":"Failed Tablet/Capsule Specifications: Some bottles contain punctured, and/or clumped/melted capsules.","untrusted":true},"packages_named":21,"fact_id":"fb9642b5902e4743573f1248"}],"meaning":"FDA classifies the health hazard of a recall, not its effect on supply"},"assistance_and_offers":{"programs_listing_this_drug":[{"name":{"text":"Pfizer RxPathways","untrusted":true},"type":"manufacturer","url":"https://www.pfizerrxpathways.com/","status":{"state":"limited","effective":"2025-01-01","applies_to":{"text":"Medicare Part D patients requesting help with a Pfizer product covered under their plan","untrusted":true},"detail":{"text":"Pfizer RxPathways states that from 2025-01-01 Medicare Part D patients must first enroll in the Medicare Prescription Payment Plan and submit proof of enrollment with their application, and, before being considered, must apply to all open, relevant diagnosis-specific independent charitable patient assistance programs and submit written proof of any denial. The page that states this is headed 2025 PAP changes; no later update was on the page when read.","untrusted":true},"read_on":"2026-11-07T07:23:55.567Z","source_url":"https://www.pfizerrxpathways.com/updates","proof_state":"verified"},"needs_status_check":true,"has_offer":false},{"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":"Venlafaxine HCl","untrusted":true},"brand":{"text":"Venlafaxine HCl ER","untrusted":true}},"latest_year":2024,"series":[{"year":2020,"gross_spending_usd":166440283.03,"claims":5130398,"beneficiaries":885226,"average_spending_per_claim_usd":32.441982675,"fact_id":"9d3fa0b801f10c8f751999de"},{"year":2021,"gross_spending_usd":165413760.05,"claims":5089789,"beneficiaries":912450,"average_spending_per_claim_usd":32.499138972,"fact_id":"df64238bbb965d019f25a5a7"},{"year":2022,"gross_spending_usd":150416115.29,"claims":5156123,"beneficiaries":934064,"average_spending_per_claim_usd":29.172328761,"fact_id":"f4d71591192406a17ba09d1e"},{"year":2023,"gross_spending_usd":151208109.91,"claims":5232570,"beneficiaries":954551,"average_spending_per_claim_usd":28.897484393,"fact_id":"ba953cb50071911ffbc9f742"},{"year":2024,"gross_spending_usd":118518033.93,"claims":5423191,"beneficiaries":993473,"average_spending_per_claim_usd":21.853929528,"fact_id":"c10637b1d6cda589b6354812"}],"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":2,"all_states_medicaid_reimbursed_usd":1347.45,"all_states_medicaid_paid_prescriptions":248,"top_states":[{"state":"KY","medicaid_paid_prescriptions":187,"medicaid_reimbursed_usd":770.72,"total_reimbursed_usd":770.72,"packages":1,"covers":"all_record_types","fact_id":"3e0f0b596554f06845303e51"},{"state":"RI","medicaid_paid_prescriptions":61,"medicaid_reimbursed_usd":576.73,"total_reimbursed_usd":576.73,"packages":1,"covers":"all_record_types","fact_id":"df47554fc27f062637b7ccd9"}],"unlabelled_state_code_xx":{"medicaid_paid_prescriptions":182,"medicaid_reimbursed_usd":2990.43,"note":"the source uses the code XX without defining it; it is reported here and never added to a state"},"built_from_facts":4,"facts_fee_for_service_only":2,"older_year_facts_not_used":615,"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). 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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:ANDA200834","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:ANDA212277","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."}