{"answer":{"query":"Premarin","resolved_as":"applications","packages":19,"applications":["NDA004782","NDA010402"],"identity":{"application_numbers":["NDA004782","NDA010402"],"marketing_categories":["NDA","NDA AUTHORIZED GENERIC"],"labelers":[],"dosage_forms":[{"text":"INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","untrusted":true},{"text":"TABLET, FILM COATED","untrusted":true}],"marketing_start":{"earliest":"1956-12-01","latest":"2026-02-27","packages_with_a_start_date":19}},"label_history":{"events_total":98,"non_cmc_events":46,"counts_by_class":{"LABELING":44,"EFFICACY":2},"cmc_events":52,"recent_non_cmc_events":[{"application":"NDA004782","submission_no":179,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2025-04-22","documents":[{"type":"Label","date":"2025-04-25","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/004782s179lbl.pdf","untrusted":true}},{"type":"Letter","date":"2025-05-01","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/004782Orig1s179ltr.pdf","untrusted":true}}],"fact_id":"15460724eed5e7035d2f27ca"},{"application":"NDA004782","submission_no":181,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2024-02-15","documents":[{"type":"Letter","date":"2024-02-16","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/004782Orig1s181ltr.pdf","untrusted":true}},{"type":"Label","date":"2024-02-20","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/004782s181lbl.pdf","untrusted":true}}],"fact_id":"dd8514c08cefdf559b00d948"},{"application":"NDA010402","submission_no":73,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2024-02-15","documents":[{"type":"Letter","date":"2024-02-16","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/010402Orig1s073ltr.pdf","untrusted":true}},{"type":"Label","date":"2024-02-20","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/010402s073lbl.pdf","untrusted":true}}],"fact_id":"0939bfddc319ce1ae6de0bea"},{"application":"NDA004782","submission_no":176,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2017-11-07","documents":[{"type":"Letter","date":"2017-11-09","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/004782Orig1s176ltr.pdf","untrusted":true}},{"type":"Label","date":"2020-07-13","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/004782s176lbl.pdf","untrusted":true}}],"fact_id":"15197d6fae251491df011689"},{"application":"NDA010402","submission_no":68,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2017-11-01","documents":[{"type":"Label","date":"2017-11-03","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/010402s068lbl.pdf","untrusted":true}},{"type":"Letter","date":"2017-11-06","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/010402Orig1s068ltr.pdf","untrusted":true}}],"fact_id":"14c7cbbfee401d2cd1baa549"}],"note":"a dated list of FDA supplements and their classes, not a reading of what changed in the label"},"substitution":{"products_total":7,"te_code_counts":{"AB":5,"NOT_PROVIDED":2},"marketing_status_counts":{"Prescription":6,"Discontinued":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":"NDA004782","product_no":"003","te_code":"AB","marketing_status":"Prescription","drug_name":{"text":"PREMARIN","untrusted":true},"form":{"text":"TABLET;ORAL","untrusted":true},"strength":{"text":"0.3MG","untrusted":true}},{"application":"NDA004782","product_no":"001","te_code":"AB","marketing_status":"Prescription","drug_name":{"text":"PREMARIN","untrusted":true},"form":{"text":"TABLET;ORAL","untrusted":true},"strength":{"text":"1.25MG","untrusted":true}},{"application":"NDA004782","product_no":"004","te_code":"AB","marketing_status":"Prescription","drug_name":{"text":"PREMARIN","untrusted":true},"form":{"text":"TABLET;ORAL","untrusted":true},"strength":{"text":"0.625MG","untrusted":true}},{"application":"NDA004782","product_no":"005","te_code":"AB","marketing_status":"Prescription","drug_name":{"text":"PREMARIN","untrusted":true},"form":{"text":"TABLET;ORAL","untrusted":true},"strength":{"text":"0.9MG","untrusted":true}},{"application":"NDA004782","product_no":"006","te_code":"AB","marketing_status":"Prescription","drug_name":{"text":"PREMARIN","untrusted":true},"form":{"text":"TABLET;ORAL","untrusted":true},"strength":{"text":"0.45MG","untrusted":true}},{"application":"NDA004782","product_no":"002","te_code":null,"marketing_status":"Discontinued","drug_name":{"text":"PREMARIN","untrusted":true},"form":{"text":"TABLET;ORAL","untrusted":true},"strength":{"text":"2.5MG","untrusted":true}},{"application":"NDA010402","product_no":"001","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"PREMARIN","untrusted":true},"form":{"text":"INJECTABLE;INJECTION","untrusted":true},"strength":{"text":"25MG/VIAL","untrusted":true}}]},"recalls":{"recalls_total":1,"counts_by_class":{"Class III":1},"packages_of_these_applications":19,"most_recent":[{"recall_number":"D-1528-2016","classification":"Class III","status":"Terminated","report_date":"2016-10-05","recall_initiated":"2016-09-15","recalling_firm":{"text":"Pfizer Inc.","untrusted":true},"reason":{"text":"Labeling: Incorrect or Missing Lot and/or Exp Date: Bottles were incorrectly labeled with an expiry date of 11/17; the correct date is 09/17.","untrusted":true},"packages_named":10,"fact_id":"f2c4f172f5e125bf2ec52ded"}],"meaning":"FDA classifies the health hazard of a recall, not its effect on supply"},"spending":{"reported_under":{"generic":{"text":"Estrogens, Conjugated","untrusted":true},"brand":{"text":"Premarin*","untrusted":true}},"latest_year":2024,"series":[{"year":2020,"gross_spending_usd":298132948.87,"claims":810976,"beneficiaries":290317,"average_spending_per_claim_usd":367.62240667,"fact_id":"56084b452a6f0273b60c547e"},{"year":2021,"gross_spending_usd":291232582.93,"claims":741459,"beneficiaries":274787,"average_spending_per_claim_usd":392.7831248,"fact_id":"9f45507c302d1e7c6037dc6d"},{"year":2022,"gross_spending_usd":281548605.22,"claims":683408,"beneficiaries":252243,"average_spending_per_claim_usd":411.97733304,"fact_id":"fb39ffc0ed090a9c83880a3f"},{"year":2023,"gross_spending_usd":279329987.49,"claims":639745,"beneficiaries":241518,"average_spending_per_claim_usd":436.62707405,"fact_id":"582184899aa145a7e169871d"},{"year":2024,"gross_spending_usd":254990017.73,"claims":610592,"beneficiaries":231894,"average_spending_per_claim_usd":417.61113433,"fact_id":"dbe7142f8006fe4c55d925d8"}],"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}}},"payment_limit":{"codes":[{"hcpcs":"J1410","quarter":"2026Q4","effective":"October 1, 2026 through December 31, 2026","payment_limit_usd":402.131,"dosage_descriptor":{"text":"25 MG","untrusted":true},"packages_matched":1,"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":"91dfd8fbfe5fab1d3180102f"}],"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"},"medicaid_state_utilization":{"year":2025,"states_with_data":5,"all_states_medicaid_reimbursed_usd":118531.97,"all_states_medicaid_paid_prescriptions":475,"top_states":[{"state":"KY","medicaid_paid_prescriptions":216,"medicaid_reimbursed_usd":53866.22,"total_reimbursed_usd":53866.22,"packages":1,"covers":"fee_for_service_only","fact_id":"ce8d36d1a54af8b0cd42ff8d"},{"state":"WA","medicaid_paid_prescriptions":95,"medicaid_reimbursed_usd":29503.7,"total_reimbursed_usd":29503.7,"packages":1,"covers":"fee_for_service_only","fact_id":"73630e6f2cd0a34e67bf16b3"},{"state":"OK","medicaid_paid_prescriptions":50,"medicaid_reimbursed_usd":12923.36,"total_reimbursed_usd":13387.16,"packages":1,"covers":"fee_for_service_only","fact_id":"129171b5a341ba4f45bbfdb0"},{"state":"PR","medicaid_paid_prescriptions":58,"medicaid_reimbursed_usd":12122.44,"total_reimbursed_usd":12122.44,"packages":1,"covers":"all_record_types","fact_id":"9857c133e1a9bc42300ecc7a"},{"state":"MA","medicaid_paid_prescriptions":56,"medicaid_reimbursed_usd":10116.25,"total_reimbursed_usd":10116.25,"packages":1,"covers":"fee_for_service_only","fact_id":"b4357f97b555e678dfd6a10a"}],"unlabelled_state_code_xx":null,"built_from_facts":5,"facts_fee_for_service_only":4,"older_year_facts_not_used":203,"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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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:NDA004782","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:NDA010402","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":"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":"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."}