{"answer":{"query":"Prolia","resolved_as":"applications","packages":4,"applications":["BLA125320"],"identity":{"application_numbers":["BLA125320"],"marketing_categories":["BLA"],"labelers":[],"dosage_forms":[{"text":"INJECTION","untrusted":true}],"marketing_start":{"earliest":"2010-06-05","latest":"2025-04-15","packages_with_a_start_date":4}},"label_history":{"events_total":50,"non_cmc_events":49,"counts_by_class":{"LABELING":34,"EFFICACY":10,"REMS":3,"S":2},"cmc_events":1,"recent_non_cmc_events":[{"application":"BLA125320","submission_no":225,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2026-06-23","documents":[{"type":"Letter","date":"2026-06-24","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/125320Orig1s225ltr.pdf","untrusted":true}},{"type":"Label","date":"2026-06-29","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/125320s225lbl.pdf","untrusted":true}}],"fact_id":"867b198691186f4b6e1dc42b"},{"application":"BLA125320","submission_no":224,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2026-06-23","documents":[{"type":"Letter","date":"2026-06-24","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/125320Orig1s224ltr.pdf","untrusted":true}},{"type":"Label","date":"2026-06-29","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/125320s224lbl.pdf","untrusted":true}},{"type":"Label","date":"2026-06-18","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/125320s224lbl.pdf#page=32","untrusted":true}}],"fact_id":"71e5c533e088323a9b8b766a"},{"application":"BLA125320","submission_no":222,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2025-05-30","documents":[{"type":"Letter","date":"2025-06-02","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/125320Orig1s222ltr.pdf","untrusted":true}},{"type":"Label","date":"2025-06-02","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/125320s222lbl.pdf","untrusted":true}}],"fact_id":"9b76a299bca67c1ebe6e60a0"},{"application":"BLA125320","submission_no":219,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2025-05-22","documents":[{"type":"Letter","date":"2025-05-27","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/125320Orig1s219ltr.pdf","untrusted":true}},{"type":"Label","date":"2025-06-02","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/125320s219lbl.pdf","untrusted":true}}],"fact_id":"37ea138c1c2c912aa1808d07"},{"application":"BLA125320","submission_no":218,"class_code":"REMS","class_description":{"text":"REMS","untrusted":true},"status":"AP","date":"2024-04-09","documents":[{"type":"Letter","date":"2024-04-10","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/125320Orig1s218ltr.pdf","untrusted":true}}],"fact_id":"cd1d522ae17f3b7079d7bba0"}],"note":"a dated list of FDA supplements and their classes, not a reading of what changed in the label"},"substitution":{"products_total":2,"te_code_counts":{"NOT_PROVIDED":2},"marketing_status_counts":{"Prescription":2},"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":"BLA125320","product_no":"002","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"XGEVA","untrusted":true},"form":{"text":"INJECTABLE; SUBCUTANEOUS","untrusted":true},"strength":{"text":"70MG/ML","untrusted":true}},{"application":"BLA125320","product_no":"001","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"PROLIA","untrusted":true},"form":{"text":"INJECTABLE; SUBCUTANEOUS","untrusted":true},"strength":{"text":"60MG/ML","untrusted":true}}]},"recalls":{"recalls_total":3,"counts_by_class":{"Class II":3},"packages_of_these_applications":4,"most_recent":[{"recall_number":"D-0538-2025","classification":"Class II","status":"Ongoing","report_date":"2025-07-30","recall_initiated":"2025-04-21","recalling_firm":{"text":"Mckesson Medical-Surgical Inc. Corporate Office","untrusted":true},"reason":{"text":"CGMP Deviations; potential temperature excursions due to transit delays","untrusted":true},"packages_named":2,"fact_id":"a2449dd00c9ff55f0e678c82"},{"recall_number":"D-0748-2018","classification":"Class II","status":"Terminated","report_date":"2018-05-16","recall_initiated":"2018-04-03","recalling_firm":{"text":"Kroger Specialty Pharmacy, Inc.","untrusted":true},"reason":{"text":"Lack of Processing Controls.","untrusted":true},"packages_named":1,"fact_id":"635ba1d8cf4cfd0399443575"},{"recall_number":"D-66318-001","classification":"Class II","status":"Terminated","report_date":"2013-11-13","recall_initiated":"2013-09-17","recalling_firm":{"text":"Amgen, Inc.","untrusted":true},"reason":{"text":"Presence of Particulate Matter: Visible cellulose fibers were observed in a small number of prefilled syringes during a routine quality examination.","untrusted":true},"packages_named":2,"fact_id":"4e64c017c6e466567685d44f"}],"meaning":"FDA classifies the health hazard of a recall, not its effect on supply"},"spending":{"reported_under":{"generic":{"text":"Denosumab","untrusted":true},"brand":{"text":"Prolia","untrusted":true}},"latest_year":2024,"series":[{"year":2020,"gross_spending_usd":369123843.39,"claims":286629,"beneficiaries":185170,"average_spending_per_claim_usd":1287.8105265,"fact_id":"a921aad806089561d5963603"},{"year":2021,"gross_spending_usd":439589885.73,"claims":316281,"beneficiaries":202494,"average_spending_per_claim_usd":1389.8713035,"fact_id":"ce4ee6317f6df1cb56dc5e1d"},{"year":2022,"gross_spending_usd":546633605.63,"claims":362308,"beneficiaries":229044,"average_spending_per_claim_usd":1508.7538935,"fact_id":"7870e1d87d952146e5447c79"},{"year":2023,"gross_spending_usd":673286886.73,"claims":403592,"beneficiaries":255565,"average_spending_per_claim_usd":1668.2364535,"fact_id":"121fee8523d2a63f4c8ba771"},{"year":2024,"gross_spending_usd":771837558.17,"claims":450858,"beneficiaries":284965,"average_spending_per_claim_usd":1711.9304929,"fact_id":"70faf0b7cf9211587227a06a"}],"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}}},"biologic_status":{"products":[{"application":"BLA125320","status":"Reference","name":{"text":"Prolia; Xgeva","untrusted":true},"proper_name":{"text":"denosumab","untrusted":true},"license_status":"Licensed","approval_date":"2010-06-01","reference_product":null,"interchangeable_date":null,"biosimilars_listed":0,"interchangeables_listed":12,"biosimilars":[],"interchangeables":[{"name":{"text":"Jubbonti; Wyost","untrusted":true},"proper_name":{"text":"denosumab-bbdz","untrusted":true},"bla_number":"761362","approval_date":"2024-03-05","interchangeable_date":"2024-03-05"},{"name":{"text":"Ponlimsi","untrusted":true},"proper_name":{"text":"denosumab-adet","untrusted":true},"bla_number":"761385","approval_date":"2026-03-27","interchangeable_date":"2026-03-27"},{"name":{"text":"Ospomyv; Xbryk","untrusted":true},"proper_name":{"text":"denosumab-dssb","untrusted":true},"bla_number":"761392","approval_date":"2025-02-13","interchangeable_date":"2025-10-29"},{"name":{"text":"Bomyntra; Conexxence","untrusted":true},"proper_name":{"text":"denosumab-bnht","untrusted":true},"bla_number":"761398","approval_date":"2025-03-25","interchangeable_date":"2025-10-29"},{"name":{"text":"Osenvelt; Stoboclo","untrusted":true},"proper_name":{"text":"denosumab-bmwo","untrusted":true},"bla_number":"761404","approval_date":"2025-02-28","interchangeable_date":"2025-10-29"},{"name":{"text":"Jubereq; Osvyrti","untrusted":true},"proper_name":{"text":"denosumab-desu","untrusted":true},"bla_number":"761424","approval_date":"2025-10-29","interchangeable_date":"2025-10-29"},{"name":{"text":"Aukelso; Bosaya","untrusted":true},"proper_name":{"text":"denosumab-kyqq","untrusted":true},"bla_number":"761436","approval_date":"2025-09-16","interchangeable_date":"2025-10-29"},{"name":{"text":"Enoby; Xtrenbo","untrusted":true},"proper_name":{"text":"denosumab-qbde","untrusted":true},"bla_number":"761439","approval_date":"2025-09-26","interchangeable_date":"2025-10-29"},{"name":{"text":"Bildyos; Bilprevda","untrusted":true},"proper_name":{"text":"denosumab-nxxp","untrusted":true},"bla_number":"761444","approval_date":"2025-08-29","interchangeable_date":"2025-10-29"},{"name":{"text":"Boncresa","untrusted":true},"proper_name":{"text":"denosumab-mobz","untrusted":true},"bla_number":"761456","approval_date":"2025-12-19","interchangeable_date":"2025-12-19"},{"name":{"text":"Oziltus","untrusted":true},"proper_name":{"text":"denosumab-mobz","untrusted":true},"bla_number":"761457","approval_date":"2025-12-19","interchangeable_date":"2025-12-19"},{"name":{"text":"Degevma","untrusted":true},"proper_name":{"text":"denosumab-adet","untrusted":true},"bla_number":"761481","approval_date":"2026-09-25","interchangeable_date":"2026-09-25"}],"purple_book_version":"purplebook-2026-10","read_on":"2026-11-07T07:33:31.186Z","fact_id":"a59ca6244ae26f0fcb1949e0"}],"reading":"what the FDA Purple Book lists on its read date, a record and not a forecast of launch or substitution"},"payment_limit":{"codes":[{"hcpcs":"J0897","quarter":"2026Q4","effective":"October 1, 2026 through December 31, 2026","payment_limit_usd":29.856,"dosage_descriptor":{"text":"1 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":"a08c50ceb5151bbd21945deb"}],"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"},"rems":{"programs":[{"application":"BLA125320","program":{"text":"Prolia","untrusted":true},"rems_id":"43","in_force":true,"released":false,"moved_to_shared_system":false,"has_etasu":false,"program_date":"2010-06-01","last_modified":"2025-06-09","source_page":"https://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=43","other_programs":0,"read_on":"2026-11-07T20:05:28.959Z","fact_id":"eaf01436105f439d2191331c"}],"reading":"what the FDA REMS@FDA files tie to the application on the read date; it does not say which prescribers or pharmacies take part or whether a patient needs the program"},"orphan_designation":{"ingredients":[{"ingredient":{"text":"denosumab","untrusted":true},"designation_count":3,"approved_count":2,"recent":[{"designated":"2021-02-02","use":{"text":"Treatment of osteogenesis imperfecta","untrusted":true},"status":"Designated/Designation Withdrawn or Revoked","sponsor":{"text":"Amgen Inc.","untrusted":true},"approved":false},{"designated":"2013-09-11","use":{"text":"Treatment of hypercalcemia in malignancy","untrusted":true},"status":"Designated/Approved","sponsor":{"text":"Amgen, Inc.","untrusted":true},"approved":true},{"designated":"2010-12-20","use":{"text":"Treatment of patients with giant cell tumor of bone","untrusted":true},"status":"Designated/Approved","sponsor":{"text":"Amgen, Inc.","untrusted":true},"approved":true}],"read_on":"2026-11-07T12:00:00.000Z","fact_id":"00debf0fe1007443aa13c68c"}],"reading":"a designation is not an approval and not a statement that the drug treats the condition; status is the FDA database's own"},"safety_communication":{"notices":[{"title":{"text":"FDA adds Boxed Warning for increased risk of severe hypocalcemia in patients with advanced chronic kidney disease taking osteoporosis medicine Prolia (denosumab)","untrusted":true},"issued":"2024-01-19","url":"https://www.fda.gov/drugs/drug-safety-communications/fda-adds-boxed-warning-increased-risk-severe-hypocalcemia-patients-advanced-chronic-kidney-disease","read_on":"2026-11-07T20:11:11.310Z","fact_id":"b8d4e7b11d58867d5bc639e5"}],"reading":"the notice as FDA published it, listed unchanged; OmniRx does not interpret it or say whether it applies to a given treatment; only the newest notice per drug is held"},"medicaid_state_utilization":{"year":2025,"states_with_data":44,"all_states_medicaid_reimbursed_usd":32639787.61,"all_states_medicaid_paid_prescriptions":32404,"top_states":[{"state":"CA","medicaid_paid_prescriptions":5098,"medicaid_reimbursed_usd":7178548.02,"total_reimbursed_usd":7394027.32,"packages":1,"covers":"all_record_types","fact_id":"857d9bff5ab3da42952ec074"},{"state":"SD","medicaid_paid_prescriptions":569,"medicaid_reimbursed_usd":2124004.1,"total_reimbursed_usd":2124004.1,"packages":1,"covers":"all_record_types","fact_id":"59ad8e2069ff9b8e2b1d5de0"},{"state":"NY","medicaid_paid_prescriptions":2313,"medicaid_reimbursed_usd":1997467.78,"total_reimbursed_usd":2828713.13,"packages":1,"covers":"all_record_types","fact_id":"2534b4c530c8f14346e47d88"},{"state":"NJ","medicaid_paid_prescriptions":1388,"medicaid_reimbursed_usd":1931930.22,"total_reimbursed_usd":2397285.66,"packages":1,"covers":"fee_for_service_only","fact_id":"78e01141c01d5ad6eb093a02"},{"state":"IL","medicaid_paid_prescriptions":1673,"medicaid_reimbursed_usd":1640412.61,"total_reimbursed_usd":2649910.83,"packages":1,"covers":"all_record_types","fact_id":"63a3b0abf2677de3f7685696"},{"state":"AZ","medicaid_paid_prescriptions":1985,"medicaid_reimbursed_usd":1624031.87,"total_reimbursed_usd":1624031.87,"packages":1,"covers":"fee_for_service_only","fact_id":"7c15a73e0f63ce6e34b22bff"},{"state":"MN","medicaid_paid_prescriptions":863,"medicaid_reimbursed_usd":1330364.12,"total_reimbursed_usd":1388853.6,"packages":2,"covers":"fee_for_service_only","fact_id":"e5da701ba92923278f441a59"},{"state":"IN","medicaid_paid_prescriptions":1614,"medicaid_reimbursed_usd":1111883.48,"total_reimbursed_usd":1562493.76,"packages":1,"covers":"all_record_types","fact_id":"683135f18c04232d58dac185"},{"state":"OH","medicaid_paid_prescriptions":1222,"medicaid_reimbursed_usd":1014980.42,"total_reimbursed_usd":1016051.89,"packages":1,"covers":"all_record_types","fact_id":"b8dc681e666b652e99eecfdb"},{"state":"PA","medicaid_paid_prescriptions":1139,"medicaid_reimbursed_usd":938095.28,"total_reimbursed_usd":1940445.93,"packages":1,"covers":"fee_for_service_only","fact_id":"fe8fe1a5ea627ac903b1ba4a"}],"unlabelled_state_code_xx":{"medicaid_paid_prescriptions":33623,"medicaid_reimbursed_usd":33469117.76,"note":"the source uses the code XX without defining it; it is reported here and never added to a state"},"built_from_facts":47,"facts_fee_for_service_only":18,"older_year_facts_not_used":96,"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":"af592bb0cead89d6492c2394","field":"ndc.listing","entity":"ndc:55513071001"},{"fact_id":"26f07fcf1e89fc904d7ed20a","field":"ndc.listing","entity":"ndc:55513071021"},{"fact_id":"3c908661f1751653f8c6d0e1","field":"ndc.listing","entity":"ndc:55513073001"},{"fact_id":"867b198691186f4b6e1dc42b","field":"drug.label_event","entity":"application:BLA125320"},{"fact_id":"71e5c533e088323a9b8b766a","field":"drug.label_event","entity":"application:BLA125320"},{"fact_id":"9b76a299bca67c1ebe6e60a0","field":"drug.label_event","entity":"application:BLA125320"},{"fact_id":"37ea138c1c2c912aa1808d07","field":"drug.label_event","entity":"application:BLA125320"},{"fact_id":"cd1d522ae17f3b7079d7bba0","field":"drug.label_event","entity":"application:BLA125320"},{"fact_id":"fcf2fc47853e878362805972","field":"drug.marketing_status","entity":"application:BLA125320"},{"fact_id":"33d8f37d1f310df64394545e","field":"drug.marketing_status","entity":"application:BLA125320"},{"fact_id":"a2449dd00c9ff55f0e678c82","field":"ndc.recall","entity":"ndc:55513071001"},{"fact_id":"635ba1d8cf4cfd0399443575","field":"ndc.recall","entity":"ndc:55513071001"},{"fact_id":"4e64c017c6e466567685d44f","field":"ndc.recall","entity":"ndc:55513071021"},{"fact_id":"a921aad806089561d5963603","field":"drug.partd_spending","entity":"drug:denosumab|prolia"},{"fact_id":"ce4ee6317f6df1cb56dc5e1d","field":"drug.partd_spending","entity":"drug:denosumab|prolia"},{"fact_id":"7870e1d87d952146e5447c79","field":"drug.partd_spending","entity":"drug:denosumab|prolia"},{"fact_id":"121fee8523d2a63f4c8ba771","field":"drug.partd_spending","entity":"drug:denosumab|prolia"},{"fact_id":"70faf0b7cf9211587227a06a","field":"drug.partd_spending","entity":"drug:denosumab|prolia"},{"fact_id":"a59ca6244ae26f0fcb1949e0","field":"drug.biologic_status","entity":"application:BLA125320"},{"fact_id":"b1897d477700d80fd9cf28a3","field":"drug.biologic_status","entity":"application:BLA761362"},{"fact_id":"a2edb88b87e56ab3c2cf8a8c","field":"drug.biologic_status","entity":"application:BLA761385"},{"fact_id":"700acc902f3f8596e24958c9","field":"drug.biologic_status","entity":"application:BLA761392"},{"fact_id":"c6dab4c3dd8945ffd2be0262","field":"drug.biologic_status","entity":"application:BLA761398"},{"fact_id":"61067ec0562fe17086c56992","field":"drug.biologic_status","entity":"application:BLA761404"},{"fact_id":"7f1aa886fde59cb68635c3cb","field":"drug.biologic_status","entity":"application:BLA761424"},{"fact_id":"c0eebc274a55629a141fc57f","field":"drug.biologic_status","entity":"application:BLA761436"},{"fact_id":"4a9b3e5dbc22f5fe932b2f8e","field":"drug.biologic_status","entity":"application:BLA761439"},{"fact_id":"d50ccfb1f5ee2222e0af7efb","field":"drug.biologic_status","entity":"application:BLA761444"},{"fact_id":"ba1701b5512af2deaec33204","field":"drug.biologic_status","entity":"application:BLA761456"},{"fact_id":"d46c02364d80f66e0619ba51","field":"drug.biologic_status","entity":"application:BLA761457"},{"fact_id":"5096dfdbd862d965282a57b6","field":"drug.biologic_status","entity":"application:BLA761481"},{"fact_id":"a08c50ceb5151bbd21945deb","field":"drug.asp_price","entity":"hcpcs:J0897"},{"fact_id":"eaf01436105f439d2191331c","field":"drug.rems","entity":"application:BLA125320"},{"fact_id":"00debf0fe1007443aa13c68c","field":"drug.orphan_designation","entity":"drug:denosumab"},{"fact_id":"b8d4e7b11d58867d5bc639e5","field":"drug.safety_communication","entity":"drug:denosumab"},{"fact_id":"857d9bff5ab3da42952ec074","field":"ndc.medicaid_state_utilization","entity":"ndc_state:55513071021:CA"},{"fact_id":"59ad8e2069ff9b8e2b1d5de0","field":"ndc.medicaid_state_utilization","entity":"ndc_state:55513071021:SD"},{"fact_id":"2534b4c530c8f14346e47d88","field":"ndc.medicaid_state_utilization","entity":"ndc_state:55513071021:NY"},{"fact_id":"78e01141c01d5ad6eb093a02","field":"ndc.medicaid_state_utilization","entity":"ndc_state:55513071021:NJ"},{"fact_id":"63a3b0abf2677de3f7685696","field":"ndc.medicaid_state_utilization","entity":"ndc_state:55513071021:IL"},{"fact_id":"7c15a73e0f63ce6e34b22bff","field":"ndc.medicaid_state_utilization","entity":"ndc_state:55513071021:AZ"},{"fact_id":"e5da701ba92923278f441a59","field":"ndc.medicaid_state_utilization","entity":"ndc_state:55513071021:MN"},{"fact_id":"683135f18c04232d58dac185","field":"ndc.medicaid_state_utilization","entity":"ndc_state:55513071021:IN"},{"fact_id":"b8dc681e666b652e99eecfdb","field":"ndc.medicaid_state_utilization","entity":"ndc_state:55513071021:OH"},{"fact_id":"fe8fe1a5ea627ac903b1ba4a","field":"ndc.medicaid_state_utilization","entity":"ndc_state:55513071021:PA"}],"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:BLA125320","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":"controlled_schedule","reason":"no DEA schedule entry matched 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."}