{"answer":{"query":"Omeprazole-Sodium Bicarbonate","resolved_as":"applications","packages":16,"applications":["ANDA079182","ANDA207476","ANDA212587"],"identity":{"application_numbers":["ANDA079182","ANDA207476","ANDA212587"],"marketing_categories":["ANDA"],"labelers":[],"dosage_forms":[{"text":"CAPSULE","untrusted":true},{"text":"POWDER, FOR SUSPENSION","untrusted":true},{"text":"CAPSULE, GELATIN COATED","untrusted":true}],"marketing_start":{"earliest":"2016-12-06","latest":"2022-10-01","packages_with_a_start_date":16}},"label_history":{"events_total":8,"non_cmc_events":8,"counts_by_class":{"LABELING":8},"cmc_events":0,"recent_non_cmc_events":[{"application":"ANDA207476","submission_no":12,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2024-01-11","documents":[],"fact_id":"1577a5454dfc888cda1fe025"},{"application":"ANDA207476","submission_no":8,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2024-01-11","documents":[],"fact_id":"e94dc5621acf601e1e7e4ca6"},{"application":"ANDA079182","submission_no":10,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2023-12-27","documents":[],"fact_id":"24c0e71f4fbad0188ca0157b"},{"application":"ANDA079182","submission_no":7,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2023-12-27","documents":[],"fact_id":"c9fe51c3bf6001153b908513"},{"application":"ANDA079182","submission_no":4,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2020-08-05","documents":[],"fact_id":"c4ae49ec78ca8a4caedb9047"}],"note":"a dated list of FDA supplements and their classes, not a reading of what changed in the label"},"substitution":{"products_total":6,"te_code_counts":{"AB":6},"marketing_status_counts":{"Prescription":6},"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":"ANDA079182","product_no":"002","te_code":"AB","marketing_status":"Prescription","drug_name":{"text":"OMEPRAZOLE AND SODIUM BICARBONATE","untrusted":true},"form":{"text":"FOR SUSPENSION;ORAL","untrusted":true},"strength":{"text":"40MG/PACKET;1.68GM/PACKET","untrusted":true}},{"application":"ANDA079182","product_no":"001","te_code":"AB","marketing_status":"Prescription","drug_name":{"text":"OMEPRAZOLE AND SODIUM BICARBONATE","untrusted":true},"form":{"text":"FOR SUSPENSION;ORAL","untrusted":true},"strength":{"text":"20MG/PACKET;1.68GM/PACKET","untrusted":true}},{"application":"ANDA207476","product_no":"001","te_code":"AB","marketing_status":"Prescription","drug_name":{"text":"OMEPRAZOLE AND SODIUM BICARBONATE","untrusted":true},"form":{"text":"CAPSULE;ORAL","untrusted":true},"strength":{"text":"20MG;1.1GM","untrusted":true}},{"application":"ANDA207476","product_no":"002","te_code":"AB","marketing_status":"Prescription","drug_name":{"text":"OMEPRAZOLE AND SODIUM BICARBONATE","untrusted":true},"form":{"text":"CAPSULE;ORAL","untrusted":true},"strength":{"text":"40MG;1.1GM","untrusted":true}},{"application":"ANDA212587","product_no":"002","te_code":"AB","marketing_status":"Prescription","drug_name":{"text":"OMEPRAZOLE AND SODIUM BICARBONATE","untrusted":true},"form":{"text":"CAPSULE;ORAL","untrusted":true},"strength":{"text":"40MG;1.1GM","untrusted":true}},{"application":"ANDA212587","product_no":"001","te_code":"AB","marketing_status":"Prescription","drug_name":{"text":"OMEPRAZOLE AND SODIUM BICARBONATE","untrusted":true},"form":{"text":"CAPSULE;ORAL","untrusted":true},"strength":{"text":"20MG;1.1GM","untrusted":true}}]},"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":"Viatris (Mylan) Patient Assistance","untrusted":true},"type":"manufacturer","url":"https://www.viatris.com/en-us/lm/united-states/patient-assistance-program","status":null,"needs_status_check":false,"has_offer":false},{"name":{"text":"Walmart $4 Prescriptions","untrusted":true},"type":"discount","url":"https://www.walmart.com/cp/4-dollar-prescriptions/1078664","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":"Omeprazole","untrusted":true},"brand":{"text":"Omeprazole","untrusted":true}},"latest_year":2024,"series":[{"year":2020,"gross_spending_usd":396295520.52,"claims":28620159,"beneficiaries":7055870,"average_spending_per_claim_usd":13.846726726,"fact_id":"e0abe90bf7fd8fa5ac06770a"},{"year":2021,"gross_spending_usd":437014108.45,"claims":28051758,"beneficiaries":7145410,"average_spending_per_claim_usd":15.578849228,"fact_id":"b8f4a63f7275947c01cd02bf"},{"year":2022,"gross_spending_usd":400120884.48,"claims":27953929,"beneficiaries":7179076,"average_spending_per_claim_usd":14.313583056,"fact_id":"728ef2651806b88f225d2b69"},{"year":2023,"gross_spending_usd":422372656.84,"claims":28144226,"beneficiaries":7298218,"average_spending_per_claim_usd":15.007435516,"fact_id":"054cabf6e85596cdddecda7f"},{"year":2024,"gross_spending_usd":366738344.22,"claims":28883231,"beneficiaries":7509766,"average_spending_per_claim_usd":12.6972756,"fact_id":"51189636c023117ff7067b16"}],"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":1,"all_states_medicaid_reimbursed_usd":15701.9,"all_states_medicaid_paid_prescriptions":425,"top_states":[{"state":"NY","medicaid_paid_prescriptions":425,"medicaid_reimbursed_usd":15701.9,"total_reimbursed_usd":15757.78,"packages":2,"covers":"fee_for_service_only","fact_id":"72d087eb256b03662afe1440"}],"unlabelled_state_code_xx":null,"built_from_facts":2,"facts_fee_for_service_only":1,"older_year_facts_not_used":13,"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":"4a6684dc42190be4241d5a2c","field":"ndc.listing","entity":"ndc:50228036305"},{"fact_id":"349cd33817290be6e32c246f","field":"ndc.listing","entity":"ndc:50228036330"},{"fact_id":"47bc8826b299afdb75c728e6","field":"ndc.listing","entity":"ndc:50228036405"},{"fact_id":"1577a5454dfc888cda1fe025","field":"drug.label_event","entity":"application:ANDA207476"},{"fact_id":"e94dc5621acf601e1e7e4ca6","field":"drug.label_event","entity":"application:ANDA207476"},{"fact_id":"24c0e71f4fbad0188ca0157b","field":"drug.label_event","entity":"application:ANDA079182"},{"fact_id":"c9fe51c3bf6001153b908513","field":"drug.label_event","entity":"application:ANDA079182"},{"fact_id":"c4ae49ec78ca8a4caedb9047","field":"drug.label_event","entity":"application:ANDA079182"},{"fact_id":"aaa822666448c648d46e9814","field":"drug.te_code","entity":"application:ANDA079182"},{"fact_id":"ce9cb498c2ad4de26d0a27c0","field":"drug.marketing_status","entity":"application:ANDA079182"},{"fact_id":"44075de582e5f9cf7d8b0d1f","field":"drug.te_code","entity":"application:ANDA079182"},{"fact_id":"3cf7a8563b900230c7d1e760","field":"drug.marketing_status","entity":"application:ANDA079182"},{"fact_id":"d54b84de48eaaaa55a6e9d72","field":"drug.te_code","entity":"application:ANDA207476"},{"fact_id":"db734e5b6510d44c6dcf2e32","field":"drug.marketing_status","entity":"application:ANDA207476"},{"fact_id":"a00463375dbd7bf3db8c9a5a","field":"drug.te_code","entity":"application:ANDA207476"},{"fact_id":"1c8c87548e65edbd077d5278","field":"drug.marketing_status","entity":"application:ANDA207476"},{"fact_id":"840a6aded04775e90cfdd55c","field":"drug.te_code","entity":"application:ANDA212587"},{"fact_id":"82beeabc6d4f32dc0ac5142c","field":"drug.marketing_status","entity":"application:ANDA212587"},{"fact_id":"44932d59c351b1d54aa00adc","field":"drug.te_code","entity":"application:ANDA212587"},{"fact_id":"ce31c1e4bfd8b2eabca4abb9","field":"drug.marketing_status","entity":"application:ANDA212587"},{"fact_id":"e0abe90bf7fd8fa5ac06770a","field":"drug.partd_spending","entity":"drug:omeprazole|omeprazole"},{"fact_id":"b8f4a63f7275947c01cd02bf","field":"drug.partd_spending","entity":"drug:omeprazole|omeprazole"},{"fact_id":"728ef2651806b88f225d2b69","field":"drug.partd_spending","entity":"drug:omeprazole|omeprazole"},{"fact_id":"054cabf6e85596cdddecda7f","field":"drug.partd_spending","entity":"drug:omeprazole|omeprazole"},{"fact_id":"51189636c023117ff7067b16","field":"drug.partd_spending","entity":"drug:omeprazole|omeprazole"},{"fact_id":"72d087eb256b03662afe1440","field":"ndc.medicaid_state_utilization","entity":"ndc_state:69097091402:NY"}],"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:ANDA079182","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:ANDA207476","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:ANDA212587","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":"policy","reason":"no Federal Register event in the edition names this drug or its programs"},{"code":"AMBIGUOUS","field":"spending","reason":"3 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."}