{"answer":{"query":"Synthroid","resolved_as":"applications","packages":39,"applications":["NDA021402"],"identity":{"application_numbers":["NDA021402"],"marketing_categories":["NDA"],"labelers":[],"dosage_forms":[{"text":"TABLET","untrusted":true}],"marketing_start":{"earliest":"2002-02-24","latest":"2016-06-03","packages_with_a_start_date":39}},"label_history":{"events_total":13,"non_cmc_events":8,"counts_by_class":{"LABELING":8},"cmc_events":5,"recent_non_cmc_events":[{"application":"NDA021402","submission_no":38,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2024-02-20","documents":[{"type":"Letter","date":"2024-02-21","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/021402Orig1s038ltr.pdf","untrusted":true}},{"type":"Label","date":"2024-02-20","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021402s038lbl.pdf","untrusted":true}}],"fact_id":"9e69630dc7717dd8582a0704"},{"application":"NDA021402","submission_no":36,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2022-08-30","documents":[{"type":"Letter","date":"2022-09-16","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/021402Orig1s036Correctedltr.pdf","untrusted":true}},{"type":"Label","date":"2022-08-31","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021402Orig1s036Correctedlbl.pdf","untrusted":true}}],"fact_id":"3da2a2ce18dcfcfbbc800765"},{"application":"NDA021402","submission_no":34,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2020-07-15","documents":[{"type":"Label","date":"2020-07-16","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021402s034lbl.pdf","untrusted":true}},{"type":"Letter","date":"2020-07-20","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021402Orig1s034ltr.pdf","untrusted":true}}],"fact_id":"cde2f4673b9bf0af06938c23"},{"application":"NDA021402","submission_no":28,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2017-02-23","documents":[{"type":"Label","date":"2017-02-24","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021402s024s028lbl.pdf","untrusted":true}},{"type":"Letter","date":"2017-03-02","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021402Orig1s024,s028ltr.pdf","untrusted":true}}],"fact_id":"0fc5a24fdcca582d5206120d"},{"application":"NDA021402","submission_no":24,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2017-02-23","documents":[{"type":"Label","date":"2017-02-24","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021402s024s028lbl.pdf","untrusted":true}},{"type":"Letter","date":"2017-03-02","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021402Orig1s024,s028ltr.pdf","untrusted":true}}],"fact_id":"0d638ab13d47ae580f804229"}],"note":"a dated list of FDA supplements and their classes, not a reading of what changed in the label"},"substitution":{"products_total":12,"te_code_counts":{"AB2":9,"AB1":3},"marketing_status_counts":{"Prescription":12},"meaning":"raw FDA codes; 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Product labeled to contain 150 mcg tablets actually contained 75 mcg tablets.","untrusted":true},"packages_named":39,"fact_id":"fd8f6083c17240384aacee1b"},{"recall_number":"D-1694-2012","classification":"Class II","status":"Terminated","report_date":"2012-10-03","recall_initiated":"2012-07-19","recalling_firm":{"text":"Abbott Laboratories","untrusted":true},"reason":{"text":"Defective Container: A number of Synthroid bottles have a localized thin wall defect on the bottom which may potentially impact the stability of the tablets.","untrusted":true},"packages_named":39,"fact_id":"f9b5747cf2dff011d51cff93"}],"meaning":"FDA classifies the health hazard of a recall, not its effect on supply"},"assistance_and_offers":{"programs_listing_this_drug":[{"name":{"text":"Teva Cares Foundation","untrusted":true},"type":"manufacturer","url":"https://www.tevacares.org/","status":null,"needs_status_check":false,"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":"Levothyroxine Sodium","untrusted":true},"brand":{"text":"Levothyroxine Sodium*","untrusted":true}},"latest_year":2024,"series":[{"year":2020,"gross_spending_usd":737828764.91,"claims":34103463,"beneficiaries":8001216,"average_spending_per_claim_usd":21.635010055,"fact_id":"bc1060a2124d6d0b08a36951"},{"year":2021,"gross_spending_usd":722461732.34,"claims":37807910,"beneficiaries":8064508,"average_spending_per_claim_usd":19.10874556,"fact_id":"7f49201401ee4a4082a2da6f"},{"year":2022,"gross_spending_usd":679474131.02,"claims":39097783,"beneficiaries":8341730,"average_spending_per_claim_usd":17.378840407,"fact_id":"485bae19e72e4f1e42660ca1"},{"year":2023,"gross_spending_usd":653580460.01,"claims":41684273,"beneficiaries":8687969,"average_spending_per_claim_usd":15.679305718,"fact_id":"f3269cac09d116cf6016cc55"},{"year":2024,"gross_spending_usd":464220464.51,"claims":43253940,"beneficiaries":9003268,"average_spending_per_claim_usd":10.732443438,"fact_id":"983f1082ef02a892cdf2533b"}],"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":19,"all_states_medicaid_reimbursed_usd":312734.37,"all_states_medicaid_paid_prescriptions":3981,"top_states":[{"state":"KY","medicaid_paid_prescriptions":1993,"medicaid_reimbursed_usd":152910.46,"total_reimbursed_usd":152910.46,"packages":3,"covers":"fee_for_service_only","fact_id":"16f0edb5393d06bac8066091"},{"state":"SD","medicaid_paid_prescriptions":120,"medicaid_reimbursed_usd":33759.41,"total_reimbursed_usd":33828.91,"packages":1,"covers":"all_record_types","fact_id":"f5b2a337521c9821333c10eb"},{"state":"UT","medicaid_paid_prescriptions":350,"medicaid_reimbursed_usd":18990.18,"total_reimbursed_usd":19012.18,"packages":5,"covers":"fee_for_service_only","fact_id":"d6e49affd830c79f7e8a315e"},{"state":"NV","medicaid_paid_prescriptions":221,"medicaid_reimbursed_usd":15235.59,"total_reimbursed_usd":16712.71,"packages":1,"covers":"all_record_types","fact_id":"96212cd5fb7ded79c0653437"},{"state":"MS","medicaid_paid_prescriptions":143,"medicaid_reimbursed_usd":9716.09,"total_reimbursed_usd":9716.09,"packages":2,"covers":"fee_for_service_only","fact_id":"792fd33371c2a485c67fa790"},{"state":"NM","medicaid_paid_prescriptions":102,"medicaid_reimbursed_usd":9516.02,"total_reimbursed_usd":9516.02,"packages":2,"covers":"fee_for_service_only","fact_id":"d7af17bca72ffadc12ff49e0"},{"state":"CA","medicaid_paid_prescriptions":136,"medicaid_reimbursed_usd":9334.32,"total_reimbursed_usd":9351.62,"packages":2,"covers":"fee_for_service_only","fact_id":"ca9fae6e7e405ceaaaf5e510"},{"state":"VT","medicaid_paid_prescriptions":61,"medicaid_reimbursed_usd":7732.26,"total_reimbursed_usd":7732.26,"packages":1,"covers":"all_record_types","fact_id":"b53254c388df560dbdbf217c"},{"state":"CT","medicaid_paid_prescriptions":55,"medicaid_reimbursed_usd":7500.44,"total_reimbursed_usd":7500.44,"packages":1,"covers":"all_record_types","fact_id":"458d2065d581bb2adc63e986"},{"state":"MT","medicaid_paid_prescriptions":119,"medicaid_reimbursed_usd":6668.11,"total_reimbursed_usd":6668.11,"packages":2,"covers":"all_record_types","fact_id":"18ba78255c6c4cd7e1e95365"}],"unlabelled_state_code_xx":null,"built_from_facts":30,"facts_fee_for_service_only":13,"older_year_facts_not_used":654,"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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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:NDA021402","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."}