{"answer":{"query":"Diclofenac Epolamine","resolved_as":"applications","packages":17,"applications":["NDA021234"],"identity":{"application_numbers":["NDA021234"],"marketing_categories":["NDA AUTHORIZED GENERIC","NDA"],"labelers":[],"dosage_forms":[{"text":"SYSTEM","untrusted":true}],"marketing_start":{"earliest":"2020-05-01","latest":"2026-08-24","packages_with_a_start_date":17}},"label_history":{"events_total":15,"non_cmc_events":14,"counts_by_class":{"LABELING":13,"EFFICACY":1},"cmc_events":1,"recent_non_cmc_events":[{"application":"NDA021234","submission_no":24,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2024-11-21","documents":[{"type":"Letter","date":"2024-11-22","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/021234Orig1s024ltr.pdf","untrusted":true}},{"type":"Label","date":"2024-11-25","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021234s024lbl.pdf","untrusted":true}}],"fact_id":"8678b1a51edd77c25ff3edb0"},{"application":"NDA021234","submission_no":19,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2021-04-28","documents":[{"type":"Letter","date":"2021-04-30","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021234Orig1s019ltr.pdf","untrusted":true}},{"type":"Label","date":"2021-05-03","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021234s019lbl.pdf","untrusted":true}}],"fact_id":"ea5eb2a9036f6aa6ed9c1273"},{"application":"NDA021234","submission_no":17,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2019-03-01","documents":[{"type":"Label","date":"2019-03-04","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021234s016s017lbl.pdf","untrusted":true}},{"type":"Letter","date":"2019-03-07","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021234Orig1s016s017ltr.pdf","untrusted":true}}],"fact_id":"dad7faf5ae4bbc7472813726"},{"application":"NDA021234","submission_no":16,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2019-03-01","documents":[{"type":"Label","date":"2019-03-04","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021234s016s017lbl.pdf","untrusted":true}},{"type":"Letter","date":"2019-03-07","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021234Orig1s016s017ltr.pdf","untrusted":true}}],"fact_id":"a7ef712010b91d211101975a"},{"application":"NDA021234","submission_no":15,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2018-08-30","documents":[{"type":"Label","date":"2018-09-05","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021234s015lbl.pdf","untrusted":true}},{"type":"Letter","date":"2018-09-13","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021234Orig1s015ltr.pdf","untrusted":true}}],"fact_id":"694f6bffa5bca0a990220c85"}],"note":"a dated list of FDA supplements and their classes, not a reading of what changed in the label"},"substitution":{"products_total":1,"te_code_counts":{"NOT_PROVIDED":1},"marketing_status_counts":{"Prescription":1},"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":"NDA021234","product_no":"001","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"FLECTOR","untrusted":true},"form":{"text":"SYSTEM;TOPICAL","untrusted":true},"strength":{"text":"1.3%","untrusted":true}}]},"spending":{"reported_under":{"generic":{"text":"Diclofenac Epolamine","untrusted":true},"brand":{"text":"Diclofenac Epolamine","untrusted":true}},"latest_year":2024,"series":[{"year":2020,"gross_spending_usd":109585242.21,"claims":147167,"beneficiaries":35529,"average_spending_per_claim_usd":744.63189581,"fact_id":"f8bcffa1d47d971dbaa3022d"},{"year":2021,"gross_spending_usd":142835345.82,"claims":187466,"beneficiaries":42059,"average_spending_per_claim_usd":761.92667374,"fact_id":"df48c11a1121443575f04c9f"},{"year":2022,"gross_spending_usd":158409927.16,"claims":211580,"beneficiaries":44042,"average_spending_per_claim_usd":748.69991096,"fact_id":"5d159291c9391f3fc9ee8b24"},{"year":2023,"gross_spending_usd":103403811.95,"claims":153910,"beneficiaries":34754,"average_spending_per_claim_usd":671.8459616,"fact_id":"dbadac9d54993cbc032d25b8"},{"year":2024,"gross_spending_usd":112425967.38,"claims":170571,"beneficiaries":34854,"average_spending_per_claim_usd":659.11536768,"fact_id":"23f134e588e093c8058df9c5"}],"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":6,"all_states_medicaid_reimbursed_usd":184609.94,"all_states_medicaid_paid_prescriptions":771,"top_states":[{"state":"NV","medicaid_paid_prescriptions":292,"medicaid_reimbursed_usd":61570.73,"total_reimbursed_usd":61570.73,"packages":1,"covers":"all_record_types","fact_id":"03fd2dfc96d22323f10658cf"},{"state":"CO","medicaid_paid_prescriptions":186,"medicaid_reimbursed_usd":29855.16,"total_reimbursed_usd":29855.16,"packages":1,"covers":"fee_for_service_only","fact_id":"f89c2ed8bcbed51db6f3b4e2"},{"state":"IN","medicaid_paid_prescriptions":70,"medicaid_reimbursed_usd":26712.53,"total_reimbursed_usd":26712.53,"packages":1,"covers":"fee_for_service_only","fact_id":"19ba247de103642265d5497f"},{"state":"PA","medicaid_paid_prescriptions":72,"medicaid_reimbursed_usd":24210.79,"total_reimbursed_usd":24738.82,"packages":1,"covers":"fee_for_service_only","fact_id":"3f22f8cafae2ee3646dbe68c"},{"state":"WI","medicaid_paid_prescriptions":80,"medicaid_reimbursed_usd":21822,"total_reimbursed_usd":21859.5,"packages":1,"covers":"all_record_types","fact_id":"23be3431363920c67852e5cd"},{"state":"MI","medicaid_paid_prescriptions":71,"medicaid_reimbursed_usd":20438.73,"total_reimbursed_usd":20438.73,"packages":1,"covers":"all_record_types","fact_id":"7afc9224c25e444e25c3c07f"}],"unlabelled_state_code_xx":null,"built_from_facts":6,"facts_fee_for_service_only":3,"older_year_facts_not_used":16,"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":"728b72e4313b25b302675820","field":"ndc.listing","entity":"ndc:00093372755"},{"fact_id":"522340bceb392a3330f24dea","field":"ndc.listing","entity":"ndc:68788411503"},{"fact_id":"5b02274bf61f52bed2583fc3","field":"ndc.listing","entity":"ndc:71858040502"},{"fact_id":"8678b1a51edd77c25ff3edb0","field":"drug.label_event","entity":"application:NDA021234"},{"fact_id":"ea5eb2a9036f6aa6ed9c1273","field":"drug.label_event","entity":"application:NDA021234"},{"fact_id":"dad7faf5ae4bbc7472813726","field":"drug.label_event","entity":"application:NDA021234"},{"fact_id":"a7ef712010b91d211101975a","field":"drug.label_event","entity":"application:NDA021234"},{"fact_id":"694f6bffa5bca0a990220c85","field":"drug.label_event","entity":"application:NDA021234"},{"fact_id":"d4f2e1b01c5764bfdfb8d4cf","field":"drug.marketing_status","entity":"application:NDA021234"},{"fact_id":"f8bcffa1d47d971dbaa3022d","field":"drug.partd_spending","entity":"drug:diclofenac-epolamine|diclofenac-epolamine"},{"fact_id":"df48c11a1121443575f04c9f","field":"drug.partd_spending","entity":"drug:diclofenac-epolamine|diclofenac-epolamine"},{"fact_id":"5d159291c9391f3fc9ee8b24","field":"drug.partd_spending","entity":"drug:diclofenac-epolamine|diclofenac-epolamine"},{"fact_id":"dbadac9d54993cbc032d25b8","field":"drug.partd_spending","entity":"drug:diclofenac-epolamine|diclofenac-epolamine"},{"fact_id":"23f134e588e093c8058df9c5","field":"drug.partd_spending","entity":"drug:diclofenac-epolamine|diclofenac-epolamine"},{"fact_id":"03fd2dfc96d22323f10658cf","field":"ndc.medicaid_state_utilization","entity":"ndc_state:00093372755:NV"},{"fact_id":"f89c2ed8bcbed51db6f3b4e2","field":"ndc.medicaid_state_utilization","entity":"ndc_state:00093372755:CO"},{"fact_id":"19ba247de103642265d5497f","field":"ndc.medicaid_state_utilization","entity":"ndc_state:00093372755:IN"},{"fact_id":"3f22f8cafae2ee3646dbe68c","field":"ndc.medicaid_state_utilization","entity":"ndc_state:00093372755:PA"},{"fact_id":"23be3431363920c67852e5cd","field":"ndc.medicaid_state_utilization","entity":"ndc_state:00093372755:WI"},{"fact_id":"7afc9224c25e444e25c3c07f","field":"ndc.medicaid_state_utilization","entity":"ndc_state:00093372755:MI"}],"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:NDA021234","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":"recalls","reason":"no FDA enforcement report naming a package of these applications is recorded"},{"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."}