{ "id": "isordil-isosorbide-dinitrate", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-31", "status": "published_traceable_archive" }, "names": { "brand": "ISORDIL", "generic": "硝酸异山梨酯", "aliases": [ "Isordil", "Isordil Titradose", "isosorbide dinitrate", "硝酸异山梨酯", "硝酸异山梨酯片", "消心痛", "isosorbide dinitrate tablets", "NDA 012093", "NDC 0187-0152-01", "NDC 0187-0192-01" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "心血管", "sourceArchiveMarket": "美国 FDA Orange Book 当前将 ISORDIL NDA 012093 的 5 mg 与 40 mg 普通口服片列为处方 RLD，其中 40 mg 同时为 RS；10 mg、20 mg、30 mg 列为 DISCN，且并非因安全性或有效性撤回。DailyMed SPL v14 仍公开 5 mg 与 40 mg 的准确 100 片瓶装面板，但两个 NDC 的营销结束日期均已列出。监管 RLD/RX 身份、公开标签和历史包装均不证明实时库存或当前可获得性。", "dosageFormClass": "普通口服片，5/10/20/30/40 mg。ISORDIL 历史另有舌下片与缓释片 NDA，本档案不把那些途径或释放方式并入口服普通片，也不与 IMDUR、MONOKET、NITROSTAT 或 BiDil 换算。", "dosageFormClassCode": "oral_modified_release", "route": "口服普通片", "routeCode": "oral", "historicalApprovalEntry": "1988-07-29（FDA Orange Book 当前数据所列批准日期）", "archiveSponsorText": "Bausch Health US LLC（FDA 当前 NDA 012093 申请主体与 DailyMed 标签主体）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [ "ISORDIL", "ISORDIL TITRADOSE", "Isordil isosorbide dinitrate", "硝酸异山梨酯片", "消心痛" ], "excludedProductCues": [ "IMDUR", "isosorbide mononitrate", "单硝酸异山梨酯", "MONOKET", "NITROSTAT", "nitroglycerin", "硝酸甘油", "BiDil", "hydralazine and isosorbide dinitrate", "ISORDIL sublingual", "ISORDIL extended release", "ISORDIL TEMBIDS" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-isordil-isosorbide-dinitrate-5mg-oral-tablet-nda-012093-product-007-ndc-0187015201", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v14（2026-02-06 生效）；包装营销结束 2025-08-31；Orange Book 当前产品类型 RX", "en": "DailyMed SPL v14 (effective 6 Feb 2026); package marketing ended 2025-08-31; current Orange Book product type RX" }, "dosageForm": { "zh": "ISORDIL 硝酸异山梨酯 5 mg 普通口服片", "en": "ISORDIL isosorbide dinitrate 5 mg immediate-release oral tablet" }, "route": { "zh": "口服普通片（不是舌下片或缓释片）", "en": "oral immediate-release tablet (not sublingual or extended release)" }, "routeCodes": [ "oral" ], "productCode": "NDA 012093 / Product 007 / NDC 0187-0152-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片硝酸异山梨酯 5 mg；Orange Book 当前处方 RLD", "en": "Isosorbide dinitrate 5 mg per tablet; current Orange Book prescription RLD" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=5-mg-label.jpg&archiveid=949353", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "硝酸异山梨酯", "en": "isosorbide dinitrate" }, "value": 5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片监管或标签标示量；不是个人片数、频率、分片或与其他硝酸酯换算依据", "en": "regulatory or labelled amount per tablet; not an individual's tablet count, frequency, splitting instruction or conversion to another nitrate" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-31", "currentLabelDisplayed": true, "ndcDirectoryListed": false, "marketAvailability": "current_regulatory_rx_rld_package_marketing_ended", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "粉红色", "en": "pink" }, "shape": { "zh": "圆形、有深刻痕；刻痕只作外观核对，不是自行分片许可", "en": "round and deeply scored; the score is an appearance clue, not permission to self-split" }, "imprint": "BPI 152", "scoreStatus": "scored_status_not_a_split_instruction", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_9457a99656cefcba", "label": "DailyMed（NLM）：ISORDIL TITRADOSE 硝酸异山梨酯 5/40 mg 美国公开标签与两个准确包装面板（SPL v14；2026-02-06 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8ddd2577-311a-4967-bb67-ad72e2b76f83", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-isordil-isosorbide-dinitrate-10mg-oral-tablet-nda-012093-product-002-source-text", "marketCode": "US", "labelVersion": { "zh": "FDA Orange Book 当前监管产品身份；产品类型 DISCN", "en": "Current FDA Orange Book regulatory product identity; product type DISCN" }, "dosageForm": { "zh": "ISORDIL 硝酸异山梨酯 10 mg 普通口服片", "en": "ISORDIL isosorbide dinitrate 10 mg immediate-release oral tablet" }, "route": { "zh": "口服普通片（不是舌下片或缓释片）", "en": "oral immediate-release tablet (not sublingual or extended release)" }, "routeCodes": [ "oral" ], "productCode": "NDA 012093 / Product 002", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片硝酸异山梨酯 10 mg；历史 RLD 当前 DISCN", "en": "Isosorbide dinitrate 10 mg per tablet; historical RLD currently DISCN" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "硝酸异山梨酯", "en": "isosorbide dinitrate" }, "value": 10, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片监管或标签标示量；不是个人片数、频率、分片或与其他硝酸酯换算依据", "en": "regulatory or labelled amount per tablet; not an individual's tablet count, frequency, splitting instruction or conversion to another nitrate" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-31", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "historical_discontinued_rld", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book：ISORDIL 硝酸异山梨酯 NDA 012093 五个普通口服片 RLD 产品状态", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-isordil-isosorbide-dinitrate-20mg-oral-tablet-nda-012093-product-006-source-text", "marketCode": "US", "labelVersion": { "zh": "FDA Orange Book 当前监管产品身份；产品类型 DISCN", "en": "Current FDA Orange Book regulatory product identity; product type DISCN" }, "dosageForm": { "zh": "ISORDIL 硝酸异山梨酯 20 mg 普通口服片", "en": "ISORDIL isosorbide dinitrate 20 mg immediate-release oral tablet" }, "route": { "zh": "口服普通片（不是舌下片或缓释片）", "en": "oral immediate-release tablet (not sublingual or extended release)" }, "routeCodes": [ "oral" ], "productCode": "NDA 012093 / Product 006", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片硝酸异山梨酯 20 mg；历史 RLD 当前 DISCN", "en": "Isosorbide dinitrate 20 mg per tablet; historical RLD currently DISCN" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "硝酸异山梨酯", "en": "isosorbide dinitrate" }, "value": 20, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片监管或标签标示量；不是个人片数、频率、分片或与其他硝酸酯换算依据", "en": "regulatory or labelled amount per tablet; not an individual's tablet count, frequency, splitting instruction or conversion to another nitrate" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-31", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "historical_discontinued_rld", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book：ISORDIL 硝酸异山梨酯 NDA 012093 五个普通口服片 RLD 产品状态", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-isordil-isosorbide-dinitrate-30mg-oral-tablet-nda-012093-product-005-source-text", "marketCode": "US", "labelVersion": { "zh": "FDA Orange Book 当前监管产品身份；产品类型 DISCN", "en": "Current FDA Orange Book regulatory product identity; product type DISCN" }, "dosageForm": { "zh": "ISORDIL 硝酸异山梨酯 30 mg 普通口服片", "en": "ISORDIL isosorbide dinitrate 30 mg immediate-release oral tablet" }, "route": { "zh": "口服普通片（不是舌下片或缓释片）", "en": "oral immediate-release tablet (not sublingual or extended release)" }, "routeCodes": [ "oral" ], "productCode": "NDA 012093 / Product 005", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片硝酸异山梨酯 30 mg；历史 RLD 当前 DISCN", "en": "Isosorbide dinitrate 30 mg per tablet; historical RLD currently DISCN" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "硝酸异山梨酯", "en": "isosorbide dinitrate" }, "value": 30, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片监管或标签标示量；不是个人片数、频率、分片或与其他硝酸酯换算依据", "en": "regulatory or labelled amount per tablet; not an individual's tablet count, frequency, splitting instruction or conversion to another nitrate" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-31", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "historical_discontinued_rld", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book：ISORDIL 硝酸异山梨酯 NDA 012093 五个普通口服片 RLD 产品状态", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-isordil-isosorbide-dinitrate-40mg-oral-tablet-nda-012093-product-001-ndc-0187019201", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v14（2026-02-06 生效）；包装营销结束 2025-08-31；Orange Book 当前产品类型 RX", "en": "DailyMed SPL v14 (effective 6 Feb 2026); package marketing ended 2025-08-31; current Orange Book product type RX" }, "dosageForm": { "zh": "ISORDIL 硝酸异山梨酯 40 mg 普通口服片", "en": "ISORDIL isosorbide dinitrate 40 mg immediate-release oral tablet" }, "route": { "zh": "口服普通片（不是舌下片或缓释片）", "en": "oral immediate-release tablet (not sublingual or extended release)" }, "routeCodes": [ "oral" ], "productCode": "NDA 012093 / Product 001 / NDC 0187-0192-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片硝酸异山梨酯 40 mg；Orange Book 当前处方 RLD、同时为 RS", "en": "Isosorbide dinitrate 40 mg per tablet; current Orange Book prescription RLD and also RS" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=label%2040-mg.jpg&archiveid=949353", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "硝酸异山梨酯", "en": "isosorbide dinitrate" }, "value": 40, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片监管或标签标示量；不是个人片数、频率、分片或与其他硝酸酯换算依据", "en": "regulatory or labelled amount per tablet; not an individual's tablet count, frequency, splitting instruction or conversion to another nitrate" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-31", "currentLabelDisplayed": true, "ndcDirectoryListed": false, "marketAvailability": "current_regulatory_rx_rld_package_marketing_ended", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "浅绿色", "en": "light green" }, "shape": { "zh": "圆形、有深刻痕；刻痕只作外观核对，不是自行分片许可", "en": "round and deeply scored; the score is an appearance clue, not permission to self-split" }, "imprint": "BPI 192", "scoreStatus": "scored_status_not_a_split_instruction", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_9457a99656cefcba", "label": "DailyMed（NLM）：ISORDIL TITRADOSE 硝酸异山梨酯 5/40 mg 美国公开标签与两个准确包装面板（SPL v14；2026-02-06 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8ddd2577-311a-4967-bb67-ad72e2b76f83", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-isordil-isosorbide-dinitrate-5mg-oral-tablet-nda-012093-product-007-ndc-0187015201", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=5-mg-label.jpg&archiveid=949353", "alt": "ISORDIL TITRADOSE 硝酸异山梨酯 5 mg、100 片、NDC 0187-0152-01 的美国 DailyMed 标签面板", "archiveMarket": "美国", "labelVersion": "DailyMed SPL v14；2026-02-06 生效；NDC 营销结束日期 2025-08-31", "presentation": "ISORDIL TITRADOSE 普通口服片，每片 5 mg，100 片瓶装，NDC 0187-0152-01。", "notice": "此图只对应美国 DailyMed 记录中的 5 mg、100 片瓶装；其 NDC 营销结束日期已经列出。它不代表当前供应，不代表 40 mg 包装、10/20/30 mg 历史产品、舌下片、缓释片或其他市场产品，且不用于鉴定真伪。", "source": { "id": "src_9457a99656cefcba", "label": "DailyMed（NLM）：ISORDIL TITRADOSE 硝酸异山梨酯 5/40 mg 美国公开标签与两个准确包装面板（SPL v14；2026-02-06 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8ddd2577-311a-4967-bb67-ad72e2b76f83", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "ISORDIL 说明书放大阅读：普通口服预防片不是急性胸痛急救药", "en": "ISORDIL enlarged label: an immediate-release oral preventive tablet is not acute chest-pain rescue" }, "summary": { "zh": "ISORDIL TITRADOSE 是硝酸异山梨酯普通口服片。美国标签明确，它的起效不够快，不能用于终止急性心绞痛。网页不根据标签生成个人服用时间表或所谓“无硝酸酯间隔”。", "en": "ISORDIL TITRADOSE is an immediate-release oral isosorbide dinitrate tablet. The U.S. label states that onset is not rapid enough to abort an acute angina episode. The site does not generate an individual schedule or nitrate-free interval from the label." }, "checks": [ { "zh": "先核对途径和释放方式：本页是口服普通片，不是舌下片，也不是缓释片；不要与 IMDUR、MONOKET、NITROSTAT 或历史 ISORDIL 舌下/缓释产品按 mg 换算、轮换或替代。", "en": "Check route and release design first: this page covers immediate-release oral tablets, not sublingual or extended-release products. Do not convert, alternate or substitute by milligrams with IMDUR, MONOKET, NITROSTAT or historical ISORDIL sublingual/extended-release products." }, { "zh": "西地那非、他达拉非、伐地那非等 PDE-5 抑制剂，以及可溶性鸟苷酸环化酶刺激剂利奥西呱，与 ISORDIL 属于禁忌核对场景；不要自行错开几小时来规避。", "en": "PDE-5 inhibitors such as sildenafil, tadalafil or vardenafil, and the soluble guanylate cyclase stimulator riociguat, are contraindication-review scenarios with ISORDIL. Do not invent a few-hour separation to bypass them." }, { "zh": "头晕、直立性低血压和晕厥可能发生；与降压药、其他血管扩张药、利尿剂或酒精同在药单时要优先核对。老人起身不稳、跌倒或晕厥应及时评估。", "en": "Dizziness, postural hypotension and syncope may occur. Co-listing antihypertensives, other vasodilators, diuretics or alcohol requires priority review. Unsteadiness on standing, a fall or fainting in an older person needs timely assessment." }, { "zh": "5 mg 与 40 mg 标签片都有深刻痕，但刻痕只是外观身份字段；网页不据此允许自行掰片。请按手中准确产品说明书和开方团队指示核对。", "en": "The labelled 5 mg and 40 mg tablets are deeply scored, but the score is an appearance-identity field and does not permit self-splitting from a website. Check the exact product label and prescriber instructions." }, { "zh": "头痛可能与硝酸酯作用有关，但不能据此自行加量、减量、停药、换药或改变服用时刻。胸痛或头痛突然严重、不同寻常或伴神经系统症状时，应立即使用当地医疗支持。", "en": "Headache may accompany nitrate action, but it is not a basis for self-increasing, reducing, stopping, switching or changing timing. Sudden severe or unusual chest pain or headache, especially with neurological symptoms, needs immediate local medical support." } ], "source": { "id": "src_9457a99656cefcba", "label": "DailyMed（NLM）：ISORDIL TITRADOSE 硝酸异山梨酯 5/40 mg 美国公开标签与两个准确包装面板（SPL v14；2026-02-06 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8ddd2577-311a-4967-bb67-ad72e2b76f83", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "硝酸异山梨酯怎样起作用：扩张静脉和动脉，降低心脏负荷", "en": "How isosorbide dinitrate works: venous and arterial dilation reduces cardiac workload" }, "summary": { "zh": "有机硝酸酯使血管平滑肌松弛，尤其扩张静脉，从而减少回心血量和心肌耗氧。这既解释了预防心绞痛的作用，也解释了头痛、头晕和低血压风险；机制不能变成个人片数或换药公式。", "en": "Organic nitrates relax vascular smooth muscle, especially veins, reducing venous return and myocardial oxygen demand. This helps explain angina prevention as well as headache, dizziness and hypotension; the mechanism is not an individual tablet-count or switching formula." }, "checks": [ { "zh": "普通口服片仍不是急救药；“立即释放”只描述剂型，不保证足够快地终止急性发作。", "en": "An immediate-release oral tablet is still not a rescue medicine; immediate release describes the dosage form and does not guarantee onset rapid enough to abort an acute attack." }, { "zh": "长期连续暴露可能产生耐受，但标签中的专业时间安排不能被网页复制成个人用药时刻表；不要自行漏服、延后或停药来制造间隔。", "en": "Continuous exposure can produce tolerance, but professional scheduling language in the label must not become a web-generated individual timetable. Do not self-skip, delay or stop doses to create an interval." }, { "zh": "二硝酸酯可代谢为单硝酸酯衍生物，并不表示 ISORDIL 与 IMDUR 是同一产品；成分、剂型、途径、释放方式和说明书都要分别核对。", "en": "Isosorbide dinitrate forms mononitrate metabolites, but that does not make ISORDIL and IMDUR the same product. Ingredient, dosage form, route, release design and label must remain separate." } ], "source": { "id": "src_9457a99656cefcba", "label": "DailyMed（NLM）：ISORDIL TITRADOSE 硝酸异山梨酯 5/40 mg 美国公开标签与两个准确包装面板（SPL v14；2026-02-06 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8ddd2577-311a-4967-bb67-ad72e2b76f83", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "ISORDIL", "generic": "硝酸异山梨酯", "dosageFormClass": "普通口服片，5/10/20/30/40 mg。ISORDIL 历史另有舌下片与缓释片 NDA，本档案不把那些途径或释放方式并入口服普通片，也不与 IMDUR、MONOKET、NITROSTAT 或 BiDil 换算。" }, "labelSource": { "id": "src_9457a99656cefcba", "label": "DailyMed（NLM）：ISORDIL TITRADOSE 硝酸异山梨酯 5/40 mg 美国公开标签与两个准确包装面板（SPL v14；2026-02-06 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8ddd2577-311a-4967-bb67-ad72e2b76f83", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" }, "productRoutes": [ { "source": { "id": "src_9457a99656cefcba", "label": "DailyMed（NLM）：ISORDIL TITRADOSE 硝酸异山梨酯 5/40 mg 美国公开标签与两个准确包装面板（SPL v14；2026-02-06 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8ddd2577-311a-4967-bb67-ad72e2b76f83", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-31", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book：ISORDIL 硝酸异山梨酯 NDA 012093 五个普通口服片 RLD 产品状态", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-29", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-31", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "ISORDIL 是硝酸异山梨酯普通口服片品牌档案，用于预防心绞痛；美国标签明确其起效不够快，不能用于终止一次急性心绞痛发作。新发、异常、剧烈或持续胸痛，或伴呼吸困难、出汗、晕厥时，应立即使用当地紧急医疗流程，不要等待口服片起效或自行追加。", "history": "FDA Orange Book 当前数据把 NDA 012093 的五种普通口服片均列出，并将批准日期记录为 1988-07-29。DailyMed SPL v14 于 2026-02-06 生效，保留 5 mg 与 40 mg 的 100 片瓶装面板及其营销结束日期；因此准确包装只作为有日期标签证据，而不是当前供应证明。", "sourceDocuments": [ { "id": "src_9457a99656cefcba", "label": "DailyMed（NLM）：ISORDIL TITRADOSE 硝酸异山梨酯 5/40 mg 美国公开标签与两个准确包装面板（SPL v14；2026-02-06 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8ddd2577-311a-4967-bb67-ad72e2b76f83", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" }, { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book：ISORDIL 硝酸异山梨酯 NDA 012093 五个普通口服片 RLD 产品状态", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } ], "applicationNumber": "美国 NDA 012093（本档案仅普通口服片）", "approvalTimeline": [ { "date": "1988-07-29", "title": { "zh": "FDA Orange Book 当前数据记录五种普通口服片批准日期", "en": "Current FDA Orange Book data record the approval date for five immediate-release oral tablets" }, "detail": { "zh": "5/10/20/30/40 mg 均在 NDA 012093 下，当前产品状态不同。", "en": "The 5/10/20/30/40 mg products are under NDA 012093 and have different current product statuses." }, "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book：ISORDIL 硝酸异山梨酯 NDA 012093 五个普通口服片 RLD 产品状态", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "date": "2026-02-06", "title": { "zh": "DailyMed SPL v14 生效", "en": "DailyMed SPL version 14 became effective" }, "detail": { "zh": "公开标签保留 5 mg 与 40 mg 的准确产品面板，并列出营销结束日期。", "en": "The public label retains exact 5 mg and 40 mg panels and lists marketing-end dates." }, "source": { "id": "src_9457a99656cefcba", "label": "DailyMed（NLM）：ISORDIL TITRADOSE 硝酸异山梨酯 5/40 mg 美国公开标签与两个准确包装面板（SPL v14；2026-02-06 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8ddd2577-311a-4967-bb67-ad72e2b76f83", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "5/40 mg 当前 RX RLD；10/20/30 mg DISCN", "en": "5/40 mg current RX RLD; 10/20/30 mg DISCN" }, "detail": { "zh": "40 mg 同时为 RS；DailyMed 精确包装营销结束日期单独显示，不推定实时供应。", "en": "40 mg is also the RS; exact DailyMed package marketing-end dates are shown separately and do not establish live supply." } }, { "market": { "zh": "其他市场", "en": "Other markets" }, "status": { "zh": "本页未建立 ISORDIL 准确品牌产品状态", "en": "No exact ISORDIL brand-product status established on this page" }, "detail": { "zh": "不得用美国 NDA、标签或包装推定中国大陆、英国、欧盟、日本或其他市场的批准、供应或可替代性。", "en": "The U.S. NDA, label or pack must not be used to infer approval, supply or interchangeability in Mainland China, the UK, EU, Japan or another market." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "胸痛发作时能不能多吃一片 ISORDIL？", "en": "Can I take an extra ISORDIL tablet during chest pain?" }, "answer": { "zh": "不要根据网页这样做。口服 ISORDIL 起效不够快，不能终止急性发作；突然或加重胸痛应按既有急救计划和当地紧急医疗流程处理。", "en": "Do not do this from a website. Oral ISORDIL does not act rapidly enough to abort an acute attack; sudden or worsening chest pain requires the existing emergency plan and local urgent-care pathway." } }, { "question": { "zh": "有刻痕就可以掰半吗？", "en": "Does a score mean the tablet can be halved?" }, "answer": { "zh": "不能只凭刻痕决定。刻痕在本页用于识别准确标签产品；是否分片必须核对手中产品的现行说明书、处方和专业指示。", "en": "A score alone does not decide this. It identifies the exact labelled product on this page; splitting requires the current label, prescription and professional instruction for the product in hand." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dose-unit-literacy", "same-class-is-not-same-medicine" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/isordil-isosorbide-dinitrate/", "en": "https://origindrug.com/en/drugs/isordil-isosorbide-dinitrate/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }