{"answer":{"query":"Risperdal Consta","resolved_as":"applications","packages":4,"applications":["NDA021346"],"identity":{"application_numbers":["NDA021346"],"marketing_categories":["NDA"],"labelers":[],"dosage_forms":[{"text":"KIT","untrusted":true}],"marketing_start":{"earliest":"2003-10-29","latest":"2003-10-29","packages_with_a_start_date":4}},"label_history":{"events_total":43,"non_cmc_events":38,"counts_by_class":{"LABELING":35,"EFFICACY":3},"cmc_events":5,"recent_non_cmc_events":[{"application":"NDA021346","submission_no":65,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2025-01-22","documents":[{"type":"Label","date":"2025-02-05","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/021346s065lbl.pdf","untrusted":true}},{"type":"Letter","date":"2025-02-07","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/021346Orig1s065,021444Orig1s060,020272Orig1s088,020588Orig1s074ltr.pdf","untrusted":true}}],"fact_id":"d263b3ea028fee22784a5ab5"},{"application":"NDA021346","submission_no":61,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2021-02-12","documents":[{"type":"Letter","date":"2021-02-17","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020272Orig1s083, 020588Orig1s071, 021444Orig1s057, 021346Orig1s061ltr.pdf","untrusted":true}},{"type":"Label","date":"2021-05-27","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020272Orig1s083,020588Orig1s071,021444Orig1s057,021346Orig1s061lbl.pdf#page=60","untrusted":true}}],"fact_id":"2e80ba63efbe21eb99825ed1"},{"application":"NDA021346","submission_no":64,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2021-01-07","documents":[{"type":"Letter","date":"2021-01-08","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021346Orig1s064ltr.pdf","untrusted":true}}],"fact_id":"2d55ce45fee011bd1fd1d9d4"},{"application":"NDA021346","submission_no":63,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2020-02-05","documents":[{"type":"Letter","date":"2020-02-06","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020272Orig1s085, 020588Orig1s072, 021444Orig1s058, 021346Orig1s063ltr.pdf","untrusted":true}},{"type":"Label","date":"2020-02-07","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021346s063lbl.pdf","untrusted":true}}],"fact_id":"fe976f6b74195ca08c3376fa"},{"application":"NDA021346","submission_no":62,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2019-11-22","documents":[],"fact_id":"c585edbd9187f2ae0711fe4b"}],"note":"a dated list of FDA supplements and their classes, not a reading of what changed in the label"},"substitution":{"products_total":4,"te_code_counts":{"AB":4},"marketing_status_counts":{"Prescription":4},"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":"NDA021346","product_no":"001","te_code":"AB","marketing_status":"Prescription","drug_name":{"text":"RISPERDAL CONSTA","untrusted":true},"form":{"text":"POWDER;INTRAMUSCULAR","untrusted":true},"strength":{"text":"25MG/VIAL","untrusted":true}},{"application":"NDA021346","product_no":"002","te_code":"AB","marketing_status":"Prescription","drug_name":{"text":"RISPERDAL CONSTA","untrusted":true},"form":{"text":"POWDER;INTRAMUSCULAR","untrusted":true},"strength":{"text":"37.5MG/VIAL","untrusted":true}},{"application":"NDA021346","product_no":"003","te_code":"AB","marketing_status":"Prescription","drug_name":{"text":"RISPERDAL CONSTA","untrusted":true},"form":{"text":"POWDER;INTRAMUSCULAR","untrusted":true},"strength":{"text":"50MG/VIAL","untrusted":true}},{"application":"NDA021346","product_no":"004","te_code":"AB","marketing_status":"Prescription","drug_name":{"text":"RISPERDAL CONSTA","untrusted":true},"form":{"text":"POWDER;INTRAMUSCULAR","untrusted":true},"strength":{"text":"12.5MG/VIAL","untrusted":true}}]},"recalls":{"recalls_total":1,"counts_by_class":{"Class II":1},"packages_of_these_applications":4,"most_recent":[{"recall_number":"D-1514-2014","classification":"Class II","status":"Terminated","report_date":"2014-08-13","recall_initiated":"2013-09-11","recalling_firm":{"text":"Janssen Pharmaceuticals, Inc.","untrusted":true},"reason":{"text":"Non-Sterility: Janssen is recalling one lot of Risperdal CONSTA (risperiDONE) due to a sterility failure in a stability sample","untrusted":true},"packages_named":4,"fact_id":"a51c0e3d0704441dfdd256ca"}],"meaning":"FDA classifies the health hazard of a recall, not its effect on supply"},"assistance_and_offers":{"programs_listing_this_drug":[{"name":{"text":"Johnson & Johnson Patient Assistance Program","untrusted":true},"type":"manufacturer","url":"https://www.jnjwithme.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":"Risperidone Microspheres","untrusted":true},"brand":{"text":"Risperdal Consta","untrusted":true}},"latest_year":2024,"series":[{"year":2020,"gross_spending_usd":212770025.54,"claims":176240,"beneficiaries":14939,"average_spending_per_claim_usd":1207.2743165,"fact_id":"f30f50d30647482815794818"},{"year":2021,"gross_spending_usd":201621100.53,"claims":160664,"beneficiaries":13598,"average_spending_per_claim_usd":1254.9239439,"fact_id":"1138d2a73bec65983bebc616"},{"year":2022,"gross_spending_usd":191210958,"claims":146832,"beneficiaries":12289,"average_spending_per_claim_usd":1302.2430941,"fact_id":"1aeed95ede679c04729c5e61"},{"year":2023,"gross_spending_usd":181758052.47,"claims":132766,"beneficiaries":11151,"average_spending_per_claim_usd":1369.0105333,"fact_id":"cbcf56ae71f1119d4c4994fc"},{"year":2024,"gross_spending_usd":114772774.9,"claims":83485,"beneficiaries":8313,"average_spending_per_claim_usd":1374.7712152,"fact_id":"399ff2f19c731f3225787919"}],"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}}},"payment_limit":{"codes":[{"hcpcs":"J2794","quarter":"2026Q4","effective":"October 1, 2026 through December 31, 2026","payment_limit_usd":10.662,"dosage_descriptor":{"text":"0.5 MG","untrusted":true},"packages_matched":4,"read_on":"2026-11-07T07:31:28.000Z","source_url":{"text":"https://www.cms.gov/medicare/payment/part-b-drugs/asp-pricing-files","untrusted":true},"fact_id":"1da3b31bb9fc6ec2842b608a"}],"codes_total":1,"meaning":"a Medicare Part B payment ceiling for providers billing a HCPCS code, per dosage descriptor unit; not a price a patient pays, and the presence of a code does not indicate that Medicare covers a product"},"medicaid_state_utilization":{"year":2025,"states_with_data":10,"all_states_medicaid_reimbursed_usd":4056819.76,"all_states_medicaid_paid_prescriptions":3480,"top_states":[{"state":"MD","medicaid_paid_prescriptions":1382,"medicaid_reimbursed_usd":1824210.23,"total_reimbursed_usd":1825529.23,"packages":3,"covers":"all_record_types","fact_id":"d9b1299cdc1625ec0c640330"},{"state":"OH","medicaid_paid_prescriptions":999,"medicaid_reimbursed_usd":946305.81,"total_reimbursed_usd":957065.42,"packages":2,"covers":"all_record_types","fact_id":"3553d9f7194152d1aac36e77"},{"state":"NC","medicaid_paid_prescriptions":439,"medicaid_reimbursed_usd":637444.06,"total_reimbursed_usd":663954.69,"packages":3,"covers":"fee_for_service_only","fact_id":"ea206c00f6089bf41a43e73b"},{"state":"NJ","medicaid_paid_prescriptions":179,"medicaid_reimbursed_usd":185484.11,"total_reimbursed_usd":185484.11,"packages":1,"covers":"fee_for_service_only","fact_id":"f36693ce203c11db6a8dfaa9"},{"state":"NH","medicaid_paid_prescriptions":110,"medicaid_reimbursed_usd":169022.23,"total_reimbursed_usd":169022.23,"packages":1,"covers":"all_record_types","fact_id":"332350cb54062d89af49ce1a"},{"state":"WA","medicaid_paid_prescriptions":124,"medicaid_reimbursed_usd":106564.58,"total_reimbursed_usd":109824.83,"packages":1,"covers":"fee_for_service_only","fact_id":"ed5c2e0d648886cadd313816"},{"state":"PR","medicaid_paid_prescriptions":65,"medicaid_reimbursed_usd":104736.91,"total_reimbursed_usd":104736.91,"packages":1,"covers":"all_record_types","fact_id":"1af7fadb5bfe949caf7350f0"},{"state":"CO","medicaid_paid_prescriptions":55,"medicaid_reimbursed_usd":35242.39,"total_reimbursed_usd":35242.39,"packages":1,"covers":"fee_for_service_only","fact_id":"9677b07a3cb1189e898e7371"},{"state":"VA","medicaid_paid_prescriptions":71,"medicaid_reimbursed_usd":29042.98,"total_reimbursed_usd":29042.98,"packages":1,"covers":"all_record_types","fact_id":"c788725b5a489254429384a2"},{"state":"IL","medicaid_paid_prescriptions":56,"medicaid_reimbursed_usd":18766.46,"total_reimbursed_usd":18766.46,"packages":1,"covers":"fee_for_service_only","fact_id":"9a6ac87f11b4bd8bdfbb5a53"}],"unlabelled_state_code_xx":null,"built_from_facts":15,"facts_fee_for_service_only":7,"older_year_facts_not_used":101,"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:NDA021346","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":"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."}