{"answer":{"query":"Prednisolone Acetate","resolved_as":"applications","packages":24,"applications":["ANDA216935","ANDA218256","NDA017011","NDA017469"],"identity":{"application_numbers":["ANDA216935","ANDA218256","NDA017011","NDA017469"],"marketing_categories":["NDA","NDA AUTHORIZED GENERIC","ANDA"],"labelers":[],"dosage_forms":[{"text":"SUSPENSION/ DROPS","untrusted":true}],"marketing_start":{"earliest":"1973-06-01","latest":"2026-07-23","packages_with_a_start_date":24}},"label_history":{"events_total":64,"non_cmc_events":16,"counts_by_class":{"LABELING":15,"EFFICACY":1},"cmc_events":48,"recent_non_cmc_events":[{"application":"NDA017469","submission_no":54,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2024-12-18","documents":[{"type":"Label","date":"2025-02-11","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/017469Orig1s054lbl.pdf","untrusted":true}},{"type":"Letter","date":"2024-12-19","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/017469Orig1s054ltr.pdf","untrusted":true}}],"fact_id":"fb545e31984e72f30d465899"},{"application":"NDA017469","submission_no":47,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2022-03-04","documents":[{"type":"Letter","date":"2022-03-07","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/017469Orig1s047ltr.pdf","untrusted":true}},{"type":"Label","date":"2022-04-19","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/017469Orig1s047lbl.pdf","untrusted":true}}],"fact_id":"f55b1c86d00b2cd6978238ef"},{"application":"NDA017011","submission_no":50,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2018-06-06","documents":[{"type":"Label","date":"2018-06-11","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/017011s050lbl.pdf","untrusted":true}},{"type":"Letter","date":"2018-06-14","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/017011Orig1s050ltr.pdf","untrusted":true}}],"fact_id":"fcd9b9d3474115618fcdff3e"},{"application":"NDA017011","submission_no":47,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2017-05-04","documents":[{"type":"Label","date":"2017-05-08","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017011s047lbl.pdf","untrusted":true}},{"type":"Letter","date":"2017-05-09","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/017011Orig1s047ltr.pdf","untrusted":true}}],"fact_id":"d241e3ea29fc099f4402bea9"},{"application":"NDA017469","submission_no":40,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2007-10-11","documents":[{"type":"Letter","date":"2007-10-15","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/017469s040ltr.pdf","untrusted":true}},{"type":"Label","date":"2007-10-15","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/017469s040lbl.pdf","untrusted":true}}],"fact_id":"b008fdb22c03fdc2e2ce7c91"}],"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":"ANDA216935","product_no":"001","te_code":"AB","marketing_status":"Prescription","drug_name":{"text":"PREDNISOLONE ACETATE","untrusted":true},"form":{"text":"SUSPENSION/DROPS;OPHTHALMIC","untrusted":true},"strength":{"text":"1%","untrusted":true}},{"application":"ANDA218256","product_no":"001","te_code":"AB","marketing_status":"Prescription","drug_name":{"text":"PREDNISOLONE ACETATE","untrusted":true},"form":{"text":"SUSPENSION/DROPS;OPHTHALMIC","untrusted":true},"strength":{"text":"1%","untrusted":true}},{"application":"NDA017011","product_no":"001","te_code":"AB","marketing_status":"Prescription","drug_name":{"text":"PRED FORTE","untrusted":true},"form":{"text":"SUSPENSION/DROPS;OPHTHALMIC","untrusted":true},"strength":{"text":"1%","untrusted":true}},{"application":"NDA017469","product_no":"001","te_code":"AB","marketing_status":"Prescription","drug_name":{"text":"OMNIPRED","untrusted":true},"form":{"text":"SUSPENSION/DROPS;OPHTHALMIC","untrusted":true},"strength":{"text":"1%","untrusted":true}}]},"recalls":{"recalls_total":2,"counts_by_class":{"Class II":2},"packages_of_these_applications":24,"most_recent":[{"recall_number":"D-0655-2026","classification":"Class II","status":"Ongoing","report_date":"2026-07-08","recall_initiated":"2026-06-04","recalling_firm":{"text":"Lupin Pharmaceuticals Inc.","untrusted":true},"reason":{"text":"Presence of Foreign Substance","untrusted":true},"packages_named":3,"fact_id":"484258bedfd321d9f42956d6"},{"recall_number":"D-1105-2022","classification":"Class II","status":"Terminated","report_date":"2022-06-15","recall_initiated":"2022-04-13","recalling_firm":{"text":"Mckesson Medical-Surgical Inc. Corporate Office","untrusted":true},"reason":{"text":"cGMP deviations: Temperature abuse","untrusted":true},"packages_named":3,"fact_id":"d83137cbf70bf6485f0b4b67"}],"meaning":"FDA classifies the health hazard of a recall, not its effect on supply"},"spending":{"reported_under":{"generic":{"text":"Prednisolone Acetate","untrusted":true},"brand":{"text":"Prednisolone Acetate","untrusted":true}},"latest_year":2024,"series":[{"year":2020,"gross_spending_usd":126406529.03,"claims":2654282,"beneficiaries":1508291,"average_spending_per_claim_usd":47.623624404,"fact_id":"c01a40c0a8e8a3d9c0cc3f54"},{"year":2021,"gross_spending_usd":158093522.76,"claims":3135996,"beneficiaries":1778548,"average_spending_per_claim_usd":50.412539672,"fact_id":"8dcf6375df53328236af30df"},{"year":2022,"gross_spending_usd":163514263.62,"claims":3295885,"beneficiaries":1885133,"average_spending_per_claim_usd":49.611641068,"fact_id":"3265df69f469cea5dd8041f6"},{"year":2023,"gross_spending_usd":163897057.32,"claims":3527776,"beneficiaries":2012515,"average_spending_per_claim_usd":46.459031787,"fact_id":"90363b60cafbacd24f33a325"},{"year":2024,"gross_spending_usd":155041337.88,"claims":3835608,"beneficiaries":2173330,"average_spending_per_claim_usd":40.421580589,"fact_id":"9c7146ea2537477fff74bedc"}],"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":48,"all_states_medicaid_reimbursed_usd":3311612.34,"all_states_medicaid_paid_prescriptions":86729,"top_states":[{"state":"NY","medicaid_paid_prescriptions":11820,"medicaid_reimbursed_usd":533194.82,"total_reimbursed_usd":534432.58,"packages":3,"covers":"fee_for_service_only","fact_id":"86bafce286a942298d75b906"},{"state":"CA","medicaid_paid_prescriptions":10087,"medicaid_reimbursed_usd":501886.65,"total_reimbursed_usd":505861.65,"packages":2,"covers":"fee_for_service_only","fact_id":"9b36da8d978af0a53ace60a4"},{"state":"MI","medicaid_paid_prescriptions":5072,"medicaid_reimbursed_usd":156387.7,"total_reimbursed_usd":158338.76,"packages":3,"covers":"fee_for_service_only","fact_id":"1cbfeb71bd14d8f5ae5398e5"},{"state":"IN","medicaid_paid_prescriptions":4289,"medicaid_reimbursed_usd":142733.85,"total_reimbursed_usd":143608.28,"packages":5,"covers":"fee_for_service_only","fact_id":"db408c6f885f15017dbd8be8"},{"state":"OH","medicaid_paid_prescriptions":4490,"medicaid_reimbursed_usd":141286.44,"total_reimbursed_usd":142018.03,"packages":2,"covers":"fee_for_service_only","fact_id":"eb313ac65ef0927266730507"},{"state":"MA","medicaid_paid_prescriptions":2631,"medicaid_reimbursed_usd":140966.38,"total_reimbursed_usd":142293.07,"packages":3,"covers":"all_record_types","fact_id":"cf2cb6afb5092154dffa9982"},{"state":"PA","medicaid_paid_prescriptions":3326,"medicaid_reimbursed_usd":128509.53,"total_reimbursed_usd":130131.49,"packages":2,"covers":"fee_for_service_only","fact_id":"27526f61cd9a68fc88f7550c"},{"state":"PR","medicaid_paid_prescriptions":3011,"medicaid_reimbursed_usd":121746.1,"total_reimbursed_usd":121835.94,"packages":2,"covers":"all_record_types","fact_id":"c525ea685efbd5cac39b0dfc"},{"state":"LA","medicaid_paid_prescriptions":2675,"medicaid_reimbursed_usd":113596.76,"total_reimbursed_usd":116820.98,"packages":3,"covers":"fee_for_service_only","fact_id":"291982b790e2dce65d292123"},{"state":"MN","medicaid_paid_prescriptions":2929,"medicaid_reimbursed_usd":108886.5,"total_reimbursed_usd":108921.5,"packages":3,"covers":"fee_for_service_only","fact_id":"11820bd23d504509911398a4"}],"unlabelled_state_code_xx":{"medicaid_paid_prescriptions":85034,"medicaid_reimbursed_usd":3234962.97,"note":"the source uses the code XX without defining it; it is reported here and never added to a state"},"built_from_facts":96,"facts_fee_for_service_only":52,"older_year_facts_not_used":226,"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":"1e8824c17acc2cfa8f511d94","field":"ndc.listing","entity":"ndc:11980018005"},{"fact_id":"bc6e1940644c390e429673d8","field":"ndc.listing","entity":"ndc:50090055900"},{"fact_id":"abdca64c7b1474155efad6bc","field":"ndc.listing","entity":"ndc:50090191200"},{"fact_id":"fb545e31984e72f30d465899","field":"drug.label_event","entity":"application:NDA017469"},{"fact_id":"f55b1c86d00b2cd6978238ef","field":"drug.label_event","entity":"application:NDA017469"},{"fact_id":"fcd9b9d3474115618fcdff3e","field":"drug.label_event","entity":"application:NDA017011"},{"fact_id":"d241e3ea29fc099f4402bea9","field":"drug.label_event","entity":"application:NDA017011"},{"fact_id":"b008fdb22c03fdc2e2ce7c91","field":"drug.label_event","entity":"application:NDA017469"},{"fact_id":"f9b387ef6495ed9b3aab85ca","field":"drug.te_code","entity":"application:ANDA216935"},{"fact_id":"711013d9748113f242d5f0e0","field":"drug.marketing_status","entity":"application:ANDA216935"},{"fact_id":"c03d8638c251673c9c77f22d","field":"drug.te_code","entity":"application:ANDA218256"},{"fact_id":"2d0c084d18fb52cfa2d34068","field":"drug.marketing_status","entity":"application:ANDA218256"},{"fact_id":"35054fa5eab1f47b619f646d","field":"drug.te_code","entity":"application:NDA017011"},{"fact_id":"9f64e8b79622efc4c5358ec4","field":"drug.marketing_status","entity":"application:NDA017011"},{"fact_id":"255b5de41258ed5294dfebf2","field":"drug.te_code","entity":"application:NDA017469"},{"fact_id":"8706e98d30c507dcf0ed69ef","field":"drug.marketing_status","entity":"application:NDA017469"},{"fact_id":"484258bedfd321d9f42956d6","field":"ndc.recall","entity":"ndc:70748033203"},{"fact_id":"d83137cbf70bf6485f0b4b67","field":"ndc.recall","entity":"ndc:61314063715"},{"fact_id":"c01a40c0a8e8a3d9c0cc3f54","field":"drug.partd_spending","entity":"drug:prednisolone-acetate|prednisolone-acetate"},{"fact_id":"8dcf6375df53328236af30df","field":"drug.partd_spending","entity":"drug:prednisolone-acetate|prednisolone-acetate"},{"fact_id":"3265df69f469cea5dd8041f6","field":"drug.partd_spending","entity":"drug:prednisolone-acetate|prednisolone-acetate"},{"fact_id":"90363b60cafbacd24f33a325","field":"drug.partd_spending","entity":"drug:prednisolone-acetate|prednisolone-acetate"},{"fact_id":"9c7146ea2537477fff74bedc","field":"drug.partd_spending","entity":"drug:prednisolone-acetate|prednisolone-acetate"},{"fact_id":"86bafce286a942298d75b906","field":"ndc.medicaid_state_utilization","entity":"ndc_state:70748033202:NY"},{"fact_id":"9b36da8d978af0a53ace60a4","field":"ndc.medicaid_state_utilization","entity":"ndc_state:70748033202:CA"},{"fact_id":"1cbfeb71bd14d8f5ae5398e5","field":"ndc.medicaid_state_utilization","entity":"ndc_state:70748033202:MI"},{"fact_id":"db408c6f885f15017dbd8be8","field":"ndc.medicaid_state_utilization","entity":"ndc_state:60758011910:IN"},{"fact_id":"eb313ac65ef0927266730507","field":"ndc.medicaid_state_utilization","entity":"ndc_state:70748033202:OH"},{"fact_id":"cf2cb6afb5092154dffa9982","field":"ndc.medicaid_state_utilization","entity":"ndc_state:60758011910:MA"},{"fact_id":"27526f61cd9a68fc88f7550c","field":"ndc.medicaid_state_utilization","entity":"ndc_state:70748033202:PA"},{"fact_id":"c525ea685efbd5cac39b0dfc","field":"ndc.medicaid_state_utilization","entity":"ndc_state:70748033202:PR"},{"fact_id":"291982b790e2dce65d292123","field":"ndc.medicaid_state_utilization","entity":"ndc_state:70748033202:LA"},{"fact_id":"11820bd23d504509911398a4","field":"ndc.medicaid_state_utilization","entity":"ndc_state:70748033202:MN"}],"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:ANDA216935","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:ANDA218256","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:NDA017011","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:NDA017469","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":"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":"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."}