{ "id": "macrobid", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-21", "status": "published_traceable_archive" }, "names": { "brand": "MACROBID", "generic": "呋喃妥因单水合物/大结晶", "aliases": [ "MACROBID", "nitrofurantoin monohydrate/macrocrystals", "呋喃妥因单水合物/大结晶", "呋喃妥因单水合物大结晶", "nitrofurantoin monohydrate macrocrystals" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "感染", "sourceArchiveMarket": "美国 MACROBID 当前公开标签（DailyMed SPL v26，2025-11-17 发布；页面 2025-10-14 更新）", "dosageFormClass": "硬明胶口服胶囊：每粒总呋喃妥因 100 mg，由 25 mg 大结晶和 75 mg 单水合物组成；仅本档案所引美国标签面板", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "当前标签未在本页建立美国初始批准年份结论", "archiveSponsorText": "Almatica Pharma LLC / DailyMed（NLM）当前公开标签" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "MACRODANTIN", "nitrofurantoin macrocrystals 50 mg", "呋喃妥因大结晶 50 mg" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-macrobid-nitrofurantoin-100mg-100-capsule-bottle-ndc-52427-285-01", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v26，2025-11-17 发布；页面 2025-10-14 更新", "en": "DailyMed SPL v26, published 17 Nov 2025; page updated 14 Oct 2025" }, "dosageForm": { "zh": "MACROBID 呋喃妥因单水合物/大结晶硬明胶口服胶囊", "en": "MACROBID nitrofurantoin monohydrate/macrocrystals hard gelatin oral capsule" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 52427-285-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒总呋喃妥因 100 mg：大结晶 25 mg + 单水合物 75 mg；100 粒瓶装", "en": "100 mg total nitrofurantoin per capsule: 25 mg macrocrystals + 75 mg monohydrate; 100-capsule bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=8f270a9f-12a1-44d4-bc7e-873613555801&name=macrobid-label.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "呋喃妥因大结晶", "en": "nitrofurantoin macrocrystals" }, "value": 25, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签中的大结晶部分；不是个人胶囊数或换算", "en": "macrocrystal portion per labelled capsule; not an individual capsule count or conversion" } }, { "ingredient": { "zh": "呋喃妥因单水合物", "en": "nitrofurantoin monohydrate" }, "value": 75, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签中的单水合物部分；不是个人胶囊数或换算", "en": "monohydrate portion per labelled capsule; not an individual capsule count or conversion" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "100 粒瓶装", "en": "100-capsule bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-21", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "黑黄双色", "en": "opaque black and yellow" }, "shape": { "zh": "硬明胶胶囊", "en": "hard gelatin capsule" }, "imprint": "Macrobid / 52427-285", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_fbaf71cc396fb018", "label": "DailyMed（NLM）：MACROBID 呋喃妥因单水合物/大结晶当前美国公开标签（Almatica Pharma；SPL v26）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8f270a9f-12a1-44d4-bc7e-873613555801", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-macrobid-nitrofurantoin-100mg-100-capsule-bottle-ndc-52427-285-01", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=8f270a9f-12a1-44d4-bc7e-873613555801&name=macrobid-label.jpg", "alt": "MACROBID 呋喃妥因单水合物/大结晶在美国 DailyMed 当前标签中的每粒总呋喃妥因 100 mg、NDC 52427-285-01、100 粒瓶装展示面", "archiveMarket": "美国", "labelVersion": "DailyMed SPL v26，2025-11-17 发布；页面 2025-10-14 更新", "presentation": "MACROBID：每粒总呋喃妥因 100 mg（大结晶 25 mg + 单水合物 75 mg），NDC 52427-285-01，100 粒瓶装展示面。", "notice": "此图只对应美国 DailyMed 当前标签中的 MACROBID、两种呋喃妥因形式、每粒总 100 mg、NDC 52427-285-01 与 100 粒瓶装。它只帮助核对品牌、通用名、制剂组成、每粒标签量、口服胶囊、外形线索、包装数量与来源；不用于鉴定真伪，也不证明 MACRODANTIN、其他呋喃妥因制剂、其他包装、其他市场、当前可得性、原研身份、可替代性或任何个人的胶囊数、疗程、换药或处理方案。", "source": { "id": "src_fbaf71cc396fb018", "label": "DailyMed（NLM）：MACROBID 呋喃妥因单水合物/大结晶当前美国公开标签（Almatica Pharma；SPL v26）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8f270a9f-12a1-44d4-bc7e-873613555801", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "MACROBID 说明书放大阅读：100 mg 是每粒总量，25 mg + 75 mg 是同一粒胶囊的两种形式", "en": "MACROBID label reading: 100 mg is the total per capsule; 25 mg + 75 mg are two forms in that same capsule" }, "summary": { "zh": "本模块只阅读美国 DailyMed 当前公开标签中的 MACROBID、两种呋喃妥因形式、每粒总量、准确 NDC、100 粒瓶装和口服胶囊。它不提供个人胶囊数、疗程、漏用处理、开始、停用、联用、换药或购买方案。", "en": "This module reads only MACROBID, its two nitrofurantoin forms, total per capsule, exact NDC, 100-capsule bottle and oral-capsule form in the current U.S. DailyMed public label. It provides no individual capsule count, course, missed-use handling, start, stop, co-use, switch or purchase plan." }, "checks": [ { "zh": "先把 MACROBID、呋喃妥因单水合物/大结晶、每粒总 100 mg、NDC 52427-285-01、100 粒瓶装、硬明胶口服胶囊和目标市场一起核对。只看到“呋喃妥因”或“100 mg”，不能证明另一种制剂、包装或国家/地区产品相同。", "en": "Check MACROBID, nitrofurantoin monohydrate/macrocrystals, 100 mg total per capsule, NDC 52427-285-01, 100-capsule bottle, hard-gelatin oral capsule and target market together. Seeing only “nitrofurantoin” or “100 mg” does not prove another formulation, package or market product is the same." }, { "zh": "标签中的 25 mg 大结晶 + 75 mg 单水合物，是这一粒 MACROBID 胶囊的两部分组成；不是两粒、两次服用，也不是把另一种 25 mg、50 mg 或 100 mg 呋喃妥因胶囊按心算拼出来的规则。", "en": "The label's 25 mg macrocrystals + 75 mg monohydrate are two parts of one MACROBID capsule; they are not two capsules, two uses, or a rule for mentally assembling another 25 mg, 50 mg or 100 mg nitrofurantoin capsule." }, { "zh": "MACRODANTIN 与仅标示“nitrofurantoin macrocrystals”的产品不是本页这份双形式 MACROBID 胶囊。相同活性成分、相近毫克数或都写“尿路抗菌药”都不足以决定能否自行替换、交替或叠加。", "en": "MACRODANTIN and products labelled only “nitrofurantoin macrocrystals” are not this two-form MACROBID capsule. A shared active ingredient, a similar milligram number or “urinary antibacterial” wording is not enough to decide self-substitution, alternation or combination." }, { "zh": "抗菌药标签的适用范围、治疗时间、与食物同服、肾功能、既往反应和全部药单都需按准确处方及目标市场现行标签处理。发热、腰背痛、恶心呕吐、皮疹、呼吸不适、黄疸样变化或其他急性问题，应使用当地医疗与开方团队渠道；不要仅凭网页自行开始、延长、重复、停用或换药。", "en": "An antibacterial label's scope, duration, food instructions, kidney function, prior reactions and complete medicine list must be handled through the exact prescription and current target-market label. With fever, flank or back pain, nausea/vomiting, rash, breathing trouble, jaundice-like changes or another acute concern, use local medical and prescribing-team pathways; do not self-start, extend, repeat, stop or switch from a webpage." } ], "source": { "id": "src_fbaf71cc396fb018", "label": "DailyMed（NLM）：MACROBID 呋喃妥因单水合物/大结晶当前美国公开标签（Almatica Pharma；SPL v26）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8f270a9f-12a1-44d4-bc7e-873613555801", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "MACROBID 的两种形式怎样影响释放阅读：较慢溶出的部分与凝胶基质释放，不等于可自行换算", "en": "How MACROBID's two forms inform release reading: slower dissolution and gel-matrix release do not permit self-conversion" }, "summary": { "zh": "当前美国标签描述：每粒 MACROBID 含两种呋喃妥因形式；大结晶部分较单水合物溶出和吸收更慢，单水合物粉末混合物在胃肠液中形成凝胶基质并随时间释放呋喃妥因。这解释制剂阅读，不预测个人疗效、尿液颜色变化、胶囊数、疗程或换药方案。", "en": "The current U.S. label describes two nitrofurantoin forms in each MACROBID capsule: the macrocrystal portion dissolves and absorbs more slowly than monohydrate, while the monohydrate powder blend forms a gel matrix in gastric and intestinal fluids that releases nitrofurantoin over time. This explains formulation reading, not individual effect, urine-colour change, capsule count, course or a switch plan." }, "checks": [ { "zh": "“较慢溶出”“凝胶基质”“随时间释放”描述的是标签所列这一准确制剂的物理药学路径；它不等于“更强”“更安全”或“可以把胶囊拆开、对半、与另一制剂换算”。", "en": "“Slower dissolution,” “gel matrix” and “releases over time” describe the pharmaceutic pathway of this exact labelled formulation; they do not mean “stronger,” “safer,” or that a capsule may be opened, halved or converted to another formulation." }, { "zh": "同为呋喃妥因、同写 100 mg 或都用于相近的泌尿问题，不表示双形式胶囊、单一大结晶胶囊、其他品牌或其他市场产品可以自行轮换、叠加或互相代替。", "en": "Sharing nitrofurantoin, a 100 mg marking or a similar urinary indication does not make a two-form capsule, a macrocrystal-only capsule, another brand or another-market product suitable for self-alternation, combination or substitution." }, { "zh": "机制和包装也不能说明某次尿路症状是否需要抗菌药、哪种产品适合、是否可继续或何时改药。出现症状加重、发热、腰背痛、严重过敏样反应、呼吸不适或其他急性问题时，应及时使用当地医疗支持。", "en": "Mechanism and packaging also cannot determine whether a urinary symptom needs an antibacterial, which product fits, whether use continues or when it changes. With worsening symptoms, fever, flank/back pain, a severe allergy-like reaction, breathing trouble or another acute concern, use timely local medical support." } ], "source": { "id": "src_fbaf71cc396fb018", "label": "DailyMed（NLM）：MACROBID 呋喃妥因单水合物/大结晶当前美国公开标签（Clinical Pharmacology）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8f270a9f-12a1-44d4-bc7e-873613555801", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "MACROBID", "generic": "呋喃妥因单水合物/大结晶", "dosageFormClass": "硬明胶口服胶囊：每粒总呋喃妥因 100 mg，由 25 mg 大结晶和 75 mg 单水合物组成；仅本档案所引美国标签面板" }, "labelSource": { "id": "src_fbaf71cc396fb018", "label": "DailyMed（NLM）：MACROBID 呋喃妥因单水合物/大结晶当前美国公开标签（Almatica Pharma；SPL v26）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8f270a9f-12a1-44d4-bc7e-873613555801", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "productRoutes": [ { "source": { "id": "src_fbaf71cc396fb018", "label": "DailyMed（NLM）：MACROBID 呋喃妥因单水合物/大结晶当前美国公开标签（Almatica Pharma；SPL v26）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8f270a9f-12a1-44d4-bc7e-873613555801", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "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": "2026-08-20", "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": "2026-08-20", "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": "美国 DailyMed 当前公开标签将 MACROBID 列为呋喃妥因单水合物/大结晶硬明胶口服胶囊；每粒总呋喃妥因 100 mg，包括 25 mg 大结晶和 75 mg 单水合物。它帮助核对商品名、两种形式、每粒标示量、准确 NDC、100 粒瓶装和美国标签来源；不把“100 mg”、两种形式或说明书文字变成个人胶囊数、疗程、开始、停用、联用、换药或购买建议。", "history": "当前标签说明大结晶部分的溶出和吸收较单水合物更慢，单水合物粉末混合物在胃肠液中形成凝胶基质并随时间释放呋喃妥因。该制剂机制不表示 MACROBID 可与 MACRODANTIN、其他呋喃妥因制剂、不同市场产品或其他抗菌药自行换算、轮换或替代。", "sourceDocuments": [ { "id": "src_fbaf71cc396fb018", "label": "DailyMed（NLM）：MACROBID 呋喃妥因单水合物/大结晶当前美国公开标签（Almatica Pharma；SPL v26）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8f270a9f-12a1-44d4-bc7e-873613555801", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "DailyMed SPL setid 8f270a9f-12a1-44d4-bc7e-873613555801 (v26)", "approvalTimeline": [ { "date": "2025-10-14", "title": { "zh": "当前 DailyMed 页面更新", "en": "Current DailyMed page updated" }, "detail": { "zh": "当前 MACROBID 页面列示更新日期为 2025-10-14。该日期只定位本页所链接的美国公开标签，不建立其他市场批准、供应、购买资格、原研/仿制关系或个人用药结论。", "en": "The current MACROBID page lists an update date of 14 Oct 2025. This date only locates the linked U.S. public label; it does not establish approval, supply, purchase eligibility, originator/generic relationship or individual-use conclusions in another market." }, "source": { "id": "src_fbaf71cc396fb018", "label": "DailyMed（NLM）：MACROBID 呋喃妥因单水合物/大结晶当前美国公开标签（Almatica Pharma；SPL v26）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8f270a9f-12a1-44d4-bc7e-873613555801", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2025-11-17", "title": { "zh": "当前 DailyMed SPL v26 公开", "en": "Current DailyMed SPL v26 published" }, "detail": { "zh": "当前标签记录列示 SPL v26 于 2025-11-17 发布。页面仅展示 NDC 52427-285-01 的 100 粒瓶装展示面，帮助核对两种呋喃妥因形式与包装身份；不建立实际在售、库存、购买、个人胶囊数、疗程、换药或可替代性。", "en": "The current label record lists SPL v26 as published on 17 Nov 2025. The page shows only the NDC 52427-285-01 100-capsule bottle panel to check the two nitrofurantoin forms and package identity; it does not establish actual availability, stock, purchase, individual capsule count, course, switching or interchangeability." }, "source": { "id": "src_fbaf71cc396fb018", "label": "DailyMed（NLM）：MACROBID 呋喃妥因单水合物/大结晶当前美国公开标签（Almatica Pharma；SPL v26）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8f270a9f-12a1-44d4-bc7e-873613555801", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接当前公开标签与一个准确 100 粒瓶装展示面", "en": "Current public label and one exact 100-capsule bottle panel linked" }, "detail": { "zh": "本页面板对应 NDC 52427-285-01，且只描述双形式 MACROBID 胶囊的标签身份。它不用于鉴定真伪，也不建立实际在售、库存、购买、个人胶囊数、疗程、开始、停用、联用、换药或可替代性。", "en": "This panel corresponds to NDC 52427-285-01 and describes only the label identity of the two-form MACROBID capsule. It does not authenticate a product or establish actual availability, stock, purchase, individual capsule count, course, initiation, stopping, co-use, switching or interchangeability." } }, { "market": { "zh": "中国大陆、欧盟、日本及其他市场", "en": "Mainland China, EU, Japan and other markets" }, "status": { "zh": "待逐项建立现行市场记录", "en": "Current market record not established" }, "detail": { "zh": "不从美国标签、NDC 或品牌名称推定当地商品名、批准、包装、供应、可售资格、原研/仿制关系或可替代性；每个市场均需按当地现行监管资料单独核对。", "en": "No local trade name, approval, packaging, supply, sale eligibility, originator/generic relationship or interchangeability is inferred from the U.S. label, NDC or brand name; every market needs separate checking against current local regulatory material." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "MACROBID 100 mg 与 MACRODANTIN 50 mg 或 100 mg 都是呋喃妥因，能否自行按毫克数换着用？", "en": "MACROBID 100 mg and MACRODANTIN 50 mg or 100 mg all name nitrofurantoin. Can they be self-converted by milligrams?" }, "answer": { "zh": "不能。当前 MACROBID 标签说明它是一粒中含 25 mg 大结晶与 75 mg 单水合物的双形式胶囊，并提到其尿中排泄数据与某些 MACRODANTIN 胶囊存在可比性；这不是个人换算、换药、轮换、叠加或决定疗程的规则。两者的准确制剂、处方目的、肾功能、既往反应和完整药单都需要由药师或开方团队核对。", "en": "No. The current MACROBID label describes a two-form capsule containing 25 mg macrocrystals and 75 mg monohydrate, and notes comparable urinary-excretion data with certain MACRODANTIN capsules. That is not a rule for self-conversion, switching, alternating, combining or deciding a course. The exact formulations, prescribing purpose, kidney function, prior reactions and complete medicine list require pharmacist or prescriber review." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/macrobid/", "en": "https://origindrug.com/en/drugs/macrobid/" }, "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." ] }