{"answer":{"query":"Nifedipine ER","resolved_as":"applications","packages":32,"applications":["ANDA077127","ANDA077410"],"identity":{"application_numbers":["ANDA077127","ANDA077410"],"marketing_categories":["ANDA"],"labelers":[],"dosage_forms":[{"text":"TABLET, FILM COATED, EXTENDED RELEASE","untrusted":true}],"marketing_start":{"earliest":"2005-11-21","latest":"2025-03-17","packages_with_a_start_date":32}},"label_history":{"events_total":2,"non_cmc_events":2,"counts_by_class":{"LABELING":2},"cmc_events":0,"recent_non_cmc_events":[{"application":"ANDA077127","submission_no":3,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2015-01-11","documents":[],"fact_id":"8890d6057717bf9a4720bc0b"},{"application":"ANDA077127","submission_no":2,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2015-01-11","documents":[],"fact_id":"cf8e815a265f6319bf60c82a"}],"note":"a dated list of FDA supplements and their classes, not a reading of what changed in the label"},"substitution":{"products_total":3,"te_code_counts":{"AB2":3},"marketing_status_counts":{"Prescription":3},"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":"ANDA077127","product_no":"001","te_code":"AB2","marketing_status":"Prescription","drug_name":{"text":"NIFEDIPINE","untrusted":true},"form":{"text":"TABLET, EXTENDED RELEASE;ORAL","untrusted":true},"strength":{"text":"30MG","untrusted":true}},{"application":"ANDA077127","product_no":"003","te_code":"AB2","marketing_status":"Prescription","drug_name":{"text":"NIFEDIPINE","untrusted":true},"form":{"text":"TABLET, EXTENDED RELEASE;ORAL","untrusted":true},"strength":{"text":"90MG","untrusted":true}},{"application":"ANDA077127","product_no":"002","te_code":"AB2","marketing_status":"Prescription","drug_name":{"text":"NIFEDIPINE","untrusted":true},"form":{"text":"TABLET, EXTENDED RELEASE;ORAL","untrusted":true},"strength":{"text":"60MG","untrusted":true}}]},"spending":{"reported_under":{"generic":{"text":"Nifedipine","untrusted":true},"brand":{"text":"Nifedipine ER","untrusted":true}},"latest_year":2024,"series":[{"year":2020,"gross_spending_usd":154050041.51,"claims":3232723,"beneficiaries":725573,"average_spending_per_claim_usd":47.653337917,"fact_id":"348c84cd71d9862b963b5d30"},{"year":2021,"gross_spending_usd":167957149.05,"claims":3216421,"beneficiaries":759505,"average_spending_per_claim_usd":52.218645833,"fact_id":"900cc53289e23fcd3e1c25e0"},{"year":2022,"gross_spending_usd":168024871.53,"claims":3315703,"beneficiaries":793835,"average_spending_per_claim_usd":50.675489189,"fact_id":"c81b3cde8134a7ce0229fb10"},{"year":2023,"gross_spending_usd":146639349.09,"claims":3524634,"beneficiaries":849024,"average_spending_per_claim_usd":41.604135093,"fact_id":"396ed85937c77818b3db6537"},{"year":2024,"gross_spending_usd":99058560.1,"claims":3845740,"beneficiaries":926326,"average_spending_per_claim_usd":25.757997186,"fact_id":"c524729ef4dfdefd6f9e84d8"}],"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}}},"orphan_designation":{"ingredients":[{"ingredient":{"text":"Nifedipine","untrusted":true},"designation_count":1,"approved_count":0,"recent":[{"designated":"1991-06-13","use":{"text":"Treatment of interstitial cystitis.","untrusted":true},"status":"Designated","sponsor":{"text":"Fleischmann, Jonathan M.D.","untrusted":true},"approved":false}],"read_on":"2026-11-07T12:00:00.000Z","fact_id":"4158ad69bcc157b712e6b94a"}],"reading":"a designation is not an approval and not a statement that the drug treats the condition; status is the FDA database's own"},"medicaid_state_utilization":{"year":2025,"states_with_data":8,"all_states_medicaid_reimbursed_usd":10242.08,"all_states_medicaid_paid_prescriptions":1000,"top_states":[{"state":"NE","medicaid_paid_prescriptions":64,"medicaid_reimbursed_usd":2123.54,"total_reimbursed_usd":2357.63,"packages":1,"covers":"all_record_types","fact_id":"49e3eb948241b04055785a2e"},{"state":"LA","medicaid_paid_prescriptions":166,"medicaid_reimbursed_usd":1923.85,"total_reimbursed_usd":1923.85,"packages":1,"covers":"all_record_types","fact_id":"cbb4b229c0b4b08dff646311"},{"state":"OK","medicaid_paid_prescriptions":116,"medicaid_reimbursed_usd":1744.29,"total_reimbursed_usd":1773.83,"packages":1,"covers":"fee_for_service_only","fact_id":"3008173a2f51c707d6327a35"},{"state":"NC","medicaid_paid_prescriptions":111,"medicaid_reimbursed_usd":1436.49,"total_reimbursed_usd":1448.1,"packages":1,"covers":"all_record_types","fact_id":"f00d4667144ece926c44da03"},{"state":"KY","medicaid_paid_prescriptions":368,"medicaid_reimbursed_usd":1046.84,"total_reimbursed_usd":1046.84,"packages":3,"covers":"all_record_types","fact_id":"e4f015ddd2c50d2a19528278"},{"state":"GA","medicaid_paid_prescriptions":50,"medicaid_reimbursed_usd":700.51,"total_reimbursed_usd":700.51,"packages":1,"covers":"fee_for_service_only","fact_id":"1c7c66521c7e88b5644f9278"},{"state":"FL","medicaid_paid_prescriptions":74,"medicaid_reimbursed_usd":690.34,"total_reimbursed_usd":690.34,"packages":1,"covers":"fee_for_service_only","fact_id":"f6e17ae86d7688de5d8946d2"},{"state":"TN","medicaid_paid_prescriptions":51,"medicaid_reimbursed_usd":576.22,"total_reimbursed_usd":637.72,"packages":1,"covers":"all_record_types","fact_id":"6689857dec99abf0df9d68d6"}],"unlabelled_state_code_xx":{"medicaid_paid_prescriptions":183,"medicaid_reimbursed_usd":294.05,"note":"the source uses the code XX without defining it; 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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":"5b7fa32e809d72cb5e3bf8b1","field":"ndc.listing","entity":"ndc:50090415800"},{"fact_id":"d2d1db7e25d2edff8fafbc9b","field":"ndc.listing","entity":"ndc:50090415801"},{"fact_id":"ed1c22927cee978f411899ae","field":"ndc.listing","entity":"ndc:50090415802"},{"fact_id":"8890d6057717bf9a4720bc0b","field":"drug.label_event","entity":"application:ANDA077127"},{"fact_id":"cf8e815a265f6319bf60c82a","field":"drug.label_event","entity":"application:ANDA077127"},{"fact_id":"a76caf744d1db137e9035ade","field":"drug.te_code","entity":"application:ANDA077127"},{"fact_id":"dfe14584fc86b63ff871b223","field":"drug.marketing_status","entity":"application:ANDA077127"},{"fact_id":"0624b233194447c0bb134f1c","field":"drug.te_code","entity":"application:ANDA077127"},{"fact_id":"716cda25d11fc63c8c301725","field":"drug.marketing_status","entity":"application:ANDA077127"},{"fact_id":"026b2e7fdf11b60cb0de24a6","field":"drug.te_code","entity":"application:ANDA077127"},{"fact_id":"cd7ef9187395c2662caba737","field":"drug.marketing_status","entity":"application:ANDA077127"},{"fact_id":"348c84cd71d9862b963b5d30","field":"drug.partd_spending","entity":"drug:nifedipine|nifedipine-er"},{"fact_id":"900cc53289e23fcd3e1c25e0","field":"drug.partd_spending","entity":"drug:nifedipine|nifedipine-er"},{"fact_id":"c81b3cde8134a7ce0229fb10","field":"drug.partd_spending","entity":"drug:nifedipine|nifedipine-er"},{"fact_id":"396ed85937c77818b3db6537","field":"drug.partd_spending","entity":"drug:nifedipine|nifedipine-er"},{"fact_id":"c524729ef4dfdefd6f9e84d8","field":"drug.partd_spending","entity":"drug:nifedipine|nifedipine-er"},{"fact_id":"4158ad69bcc157b712e6b94a","field":"drug.orphan_designation","entity":"drug:nifedipine"},{"fact_id":"49e3eb948241b04055785a2e","field":"ndc.medicaid_state_utilization","entity":"ndc_state:62175026232:NE"},{"fact_id":"cbb4b229c0b4b08dff646311","field":"ndc.medicaid_state_utilization","entity":"ndc_state:62175026046:LA"},{"fact_id":"3008173a2f51c707d6327a35","field":"ndc.medicaid_state_utilization","entity":"ndc_state:62175026232:OK"},{"fact_id":"f00d4667144ece926c44da03","field":"ndc.medicaid_state_utilization","entity":"ndc_state:62175026037:NC"},{"fact_id":"e4f015ddd2c50d2a19528278","field":"ndc.medicaid_state_utilization","entity":"ndc_state:62175026037:KY"},{"fact_id":"1c7c66521c7e88b5644f9278","field":"ndc.medicaid_state_utilization","entity":"ndc_state:62175026137:GA"},{"fact_id":"f6e17ae86d7688de5d8946d2","field":"ndc.medicaid_state_utilization","entity":"ndc_state:62175026037:FL"},{"fact_id":"6689857dec99abf0df9d68d6","field":"ndc.medicaid_state_utilization","entity":"ndc_state:62175026037:TN"}],"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:ANDA077127","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:ANDA077410","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":"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":"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."}