{ "id": "oxycontin", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-30", "status": "published_traceable_archive" }, "names": { "brand": "OXYCONTIN", "generic": "盐酸羟考酮控释片", "aliases": [ "OxyContin", "oxycodone hydrochloride extended-release tablets", "oxycodone ER", "盐酸羟考酮控释片", "羟考酮控释片", "奥施康定", "oxycodone hydrochloride extended-release", "NDA 022272", "NDC 59011-410-10", "NDC 59011-415-10", "NDC 59011-420-10", "NDC 59011-430-10", "NDC 59011-440-10", "NDC 59011-460-10", "NDC 59011-480-10", "OP 10", "OP 15", "OP 20", "OP 30", "OP 40", "OP 60", "OP 80" ], "marketBrandNames": [ { "name": "OXYCONTIN", "market": { "zh": "美国", "en": "United States" }, "evidenceStatus": "current_regulatory_record", "note": { "zh": "当前 DailyMed 标签列示 NDA 022272、CII、七个强度和准确包装；不据此推定实际库存或其他市场状态。", "en": "The current DailyMed label lists NDA 022272, CII, seven strengths and exact packages; it does not establish actual stock or another market's status." }, "source": { "id": "src_2b7fe1b4e3f71fd0", "label": "DailyMed（NLM）：OXYCONTIN 盐酸羟考酮控释片当前美国公开标签（Knoa Pharma；SPL v44，2026-06-24 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=bfdfe235-d717-4855-a3c8-a13d26dadede", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } } ], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "疼痛与炎症", "sourceArchiveMarket": "美国 DailyMed 当前 OXYCONTIN 标签（SPL v44，2026-06-24 生效）列示 NDA 022272、10/15/20/30/40/60/80 mg 控释片、对应 100 片瓶装和单位剂量包装；本页只展示七个逐一匹配的 100 片瓶装面板。美国 CII 标签、NDA、NDC 或包装图不证明中国大陆或其他市场批准、供应、购买资格、真伪或可替代性。", "dosageFormClass": "盐酸羟考酮薄膜衣控释片；必须整片吞服。不得切开、掰开、咀嚼、碾碎或溶解；普通羟考酮、羟考酮/对乙酰氨基酚复方、另一种羟考酮控释胶囊和历史原配方均不并入本档案。", "dosageFormClassCode": "oral_solid", "route": "口服；必须整片吞服（高风险控释产品身份字段）", "routeCode": "oral", "historicalApprovalEntry": "2010（美国当前重配方 NDA 022272 批准节点；标签所列 1950 是羟考酮的美国初始批准年份，不等同于 OXYCONTIN 品牌年份）", "archiveSponsorText": "Knoa Pharma LLC（当前 DailyMed 标签包装方）；FDA NDA 022272" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [ "OXYCONTIN", "OxyContin", "盐酸羟考酮控释片", "羟考酮控释片", "奥施康定" ], "excludedProductCues": [ "immediate-release oxycodone", "oxycodone immediate-release", "盐酸羟考酮普通片", "PERCOCET", "oxycodone and acetaminophen", "XTAMPZA ER", "oxycodone extended-release capsules", "original OXYCONTIN formulation NDA 020553" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-oxycontin-oxycodone-hydrochloride-er-tablet-10mg-100-bottle-ndc-59011-410-10", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（SPL v44，2026-06-24 生效）", "en": "Current U.S. DailyMed public label (SPL v44, effective 24 Jun 2026)" }, "dosageForm": { "zh": "OXYCONTIN 盐酸羟考酮控释口服片", "en": "OXYCONTIN oxycodone hydrochloride extended-release oral tablet" }, "route": { "zh": "口服；必须整片吞服", "en": "oral; must be swallowed whole" }, "routeCodes": [ "oral" ], "productCode": "NDC 59011-410-10", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片盐酸羟考酮 10 mg；100 片儿童防开启瓶装", "en": "Oxycodone hydrochloride 10 mg per tablet; 100-tablet child-resistant bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=oxycontin-03.jpg&setid=bfdfe235-d717-4855-a3c8-a13d26dadede&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸羟考酮（每片）", "en": "oxycodone hydrochloride (per tablet)" }, "value": 10, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频率、转换或补服指令", "en": "labelled amount per tablet; not an individual's tablet count, frequency, conversion or missed-use instruction" } } ], "concentration": null, "container": { "typeCode": "child_resistant_bottle", "typeLabel": { "zh": "儿童防开启瓶", "en": "child-resistant bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-30", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "圆形、双凸、薄膜衣控释片", "en": "round, biconvex, film-coated extended-release tablet" }, "imprint": "OP / 10", "scoreStatus": "not_stated_in_label_whole_tablet_required", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_2b7fe1b4e3f71fd0", "label": "DailyMed（NLM）：OXYCONTIN 盐酸羟考酮控释片当前美国公开标签（Knoa Pharma；SPL v44，2026-06-24 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=bfdfe235-d717-4855-a3c8-a13d26dadede", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-oxycontin-oxycodone-hydrochloride-er-tablet-15mg-100-bottle-ndc-59011-415-10", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（SPL v44，2026-06-24 生效）", "en": "Current U.S. DailyMed public label (SPL v44, effective 24 Jun 2026)" }, "dosageForm": { "zh": "OXYCONTIN 盐酸羟考酮控释口服片", "en": "OXYCONTIN oxycodone hydrochloride extended-release oral tablet" }, "route": { "zh": "口服；必须整片吞服", "en": "oral; must be swallowed whole" }, "routeCodes": [ "oral" ], "productCode": "NDC 59011-415-10", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片盐酸羟考酮 15 mg；100 片儿童防开启瓶装", "en": "Oxycodone hydrochloride 15 mg per tablet; 100-tablet child-resistant bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=oxycontin-04.jpg&setid=bfdfe235-d717-4855-a3c8-a13d26dadede&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸羟考酮（每片）", "en": "oxycodone hydrochloride (per tablet)" }, "value": 15, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频率、转换或补服指令", "en": "labelled amount per tablet; not an individual's tablet count, frequency, conversion or missed-use instruction" } } ], "concentration": null, "container": { "typeCode": "child_resistant_bottle", "typeLabel": { "zh": "儿童防开启瓶", "en": "child-resistant bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-30", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "灰色", "en": "gray" }, "shape": { "zh": "圆形、双凸、薄膜衣控释片", "en": "round, biconvex, film-coated extended-release tablet" }, "imprint": "OP / 15", "scoreStatus": "not_stated_in_label_whole_tablet_required", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_2b7fe1b4e3f71fd0", "label": "DailyMed（NLM）：OXYCONTIN 盐酸羟考酮控释片当前美国公开标签（Knoa Pharma；SPL v44，2026-06-24 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=bfdfe235-d717-4855-a3c8-a13d26dadede", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-oxycontin-oxycodone-hydrochloride-er-tablet-20mg-100-bottle-ndc-59011-420-10", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（SPL v44，2026-06-24 生效）", "en": "Current U.S. DailyMed public label (SPL v44, effective 24 Jun 2026)" }, "dosageForm": { "zh": "OXYCONTIN 盐酸羟考酮控释口服片", "en": "OXYCONTIN oxycodone hydrochloride extended-release oral tablet" }, "route": { "zh": "口服；必须整片吞服", "en": "oral; must be swallowed whole" }, "routeCodes": [ "oral" ], "productCode": "NDC 59011-420-10", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片盐酸羟考酮 20 mg；100 片儿童防开启瓶装", "en": "Oxycodone hydrochloride 20 mg per tablet; 100-tablet child-resistant bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=oxycontin-05.jpg&setid=bfdfe235-d717-4855-a3c8-a13d26dadede&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸羟考酮（每片）", "en": "oxycodone hydrochloride (per tablet)" }, "value": 20, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频率、转换或补服指令", "en": "labelled amount per tablet; not an individual's tablet count, frequency, conversion or missed-use instruction" } } ], "concentration": null, "container": { "typeCode": "child_resistant_bottle", "typeLabel": { "zh": "儿童防开启瓶", "en": "child-resistant bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-30", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "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、双凸、薄膜衣控释片", "en": "round, biconvex, film-coated extended-release tablet" }, "imprint": "OP / 20", "scoreStatus": "not_stated_in_label_whole_tablet_required", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_2b7fe1b4e3f71fd0", "label": "DailyMed（NLM）：OXYCONTIN 盐酸羟考酮控释片当前美国公开标签（Knoa Pharma；SPL v44，2026-06-24 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=bfdfe235-d717-4855-a3c8-a13d26dadede", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-oxycontin-oxycodone-hydrochloride-er-tablet-30mg-100-bottle-ndc-59011-430-10", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（SPL v44，2026-06-24 生效）", "en": "Current U.S. DailyMed public label (SPL v44, effective 24 Jun 2026)" }, "dosageForm": { "zh": "OXYCONTIN 盐酸羟考酮控释口服片", "en": "OXYCONTIN oxycodone hydrochloride extended-release oral tablet" }, "route": { "zh": "口服；必须整片吞服", "en": "oral; must be swallowed whole" }, "routeCodes": [ "oral" ], "productCode": "NDC 59011-430-10", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片盐酸羟考酮 30 mg；100 片儿童防开启瓶装", "en": "Oxycodone hydrochloride 30 mg per tablet; 100-tablet child-resistant bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=oxycontin-06.jpg&setid=bfdfe235-d717-4855-a3c8-a13d26dadede&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸羟考酮（每片）", "en": "oxycodone hydrochloride (per tablet)" }, "value": 30, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频率、转换或补服指令", "en": "labelled amount per tablet; not an individual's tablet count, frequency, conversion or missed-use instruction" } } ], "concentration": null, "container": { "typeCode": "child_resistant_bottle", "typeLabel": { "zh": "儿童防开启瓶", "en": "child-resistant bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-30", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "棕色", "en": "brown" }, "shape": { "zh": "圆形、双凸、薄膜衣控释片", "en": "round, biconvex, film-coated extended-release tablet" }, "imprint": "OP / 30", "scoreStatus": "not_stated_in_label_whole_tablet_required", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_2b7fe1b4e3f71fd0", "label": "DailyMed（NLM）：OXYCONTIN 盐酸羟考酮控释片当前美国公开标签（Knoa Pharma；SPL v44，2026-06-24 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=bfdfe235-d717-4855-a3c8-a13d26dadede", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-oxycontin-oxycodone-hydrochloride-er-tablet-40mg-100-bottle-ndc-59011-440-10", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（SPL v44，2026-06-24 生效）", "en": "Current U.S. DailyMed public label (SPL v44, effective 24 Jun 2026)" }, "dosageForm": { "zh": "OXYCONTIN 盐酸羟考酮控释口服片", "en": "OXYCONTIN oxycodone hydrochloride extended-release oral tablet" }, "route": { "zh": "口服；必须整片吞服", "en": "oral; must be swallowed whole" }, "routeCodes": [ "oral" ], "productCode": "NDC 59011-440-10", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片盐酸羟考酮 40 mg；100 片儿童防开启瓶装", "en": "Oxycodone hydrochloride 40 mg per tablet; 100-tablet child-resistant bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=oxycontin-07.jpg&setid=bfdfe235-d717-4855-a3c8-a13d26dadede&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸羟考酮（每片）", "en": "oxycodone hydrochloride (per tablet)" }, "value": 40, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频率、转换或补服指令", "en": "labelled amount per tablet; not an individual's tablet count, frequency, conversion or missed-use instruction" } } ], "concentration": null, "container": { "typeCode": "child_resistant_bottle", "typeLabel": { "zh": "儿童防开启瓶", "en": "child-resistant bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-30", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "黄色", "en": "yellow" }, "shape": { "zh": "圆形、双凸、薄膜衣控释片", "en": "round, biconvex, film-coated extended-release tablet" }, "imprint": "OP / 40", "scoreStatus": "not_stated_in_label_whole_tablet_required", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_2b7fe1b4e3f71fd0", "label": "DailyMed（NLM）：OXYCONTIN 盐酸羟考酮控释片当前美国公开标签（Knoa Pharma；SPL v44，2026-06-24 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=bfdfe235-d717-4855-a3c8-a13d26dadede", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-oxycontin-oxycodone-hydrochloride-er-tablet-60mg-100-bottle-ndc-59011-460-10", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（SPL v44，2026-06-24 生效）", "en": "Current U.S. DailyMed public label (SPL v44, effective 24 Jun 2026)" }, "dosageForm": { "zh": "OXYCONTIN 盐酸羟考酮控释口服片", "en": "OXYCONTIN oxycodone hydrochloride extended-release oral tablet" }, "route": { "zh": "口服；必须整片吞服", "en": "oral; must be swallowed whole" }, "routeCodes": [ "oral" ], "productCode": "NDC 59011-460-10", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片盐酸羟考酮 60 mg；100 片儿童防开启瓶装；标签注明仅供已建立阿片耐受者", "en": "Oxycodone hydrochloride 60 mg per tablet; 100-tablet child-resistant bottle; label states for opioid-tolerant patients only" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=oxycontin-08.jpg&setid=bfdfe235-d717-4855-a3c8-a13d26dadede&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸羟考酮（每片）", "en": "oxycodone hydrochloride (per tablet)" }, "value": 60, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频率、转换或补服指令", "en": "labelled amount per tablet; not an individual's tablet count, frequency, conversion or missed-use instruction" } } ], "concentration": null, "container": { "typeCode": "child_resistant_bottle", "typeLabel": { "zh": "儿童防开启瓶", "en": "child-resistant bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-30", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "红色", "en": "red" }, "shape": { "zh": "圆形、双凸、薄膜衣控释片", "en": "round, biconvex, film-coated extended-release tablet" }, "imprint": "OP / 60", "scoreStatus": "not_stated_in_label_whole_tablet_required", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_2b7fe1b4e3f71fd0", "label": "DailyMed（NLM）：OXYCONTIN 盐酸羟考酮控释片当前美国公开标签（Knoa Pharma；SPL v44，2026-06-24 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=bfdfe235-d717-4855-a3c8-a13d26dadede", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-oxycontin-oxycodone-hydrochloride-er-tablet-80mg-100-bottle-ndc-59011-480-10", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（SPL v44，2026-06-24 生效）", "en": "Current U.S. DailyMed public label (SPL v44, effective 24 Jun 2026)" }, "dosageForm": { "zh": "OXYCONTIN 盐酸羟考酮控释口服片", "en": "OXYCONTIN oxycodone hydrochloride extended-release oral tablet" }, "route": { "zh": "口服；必须整片吞服", "en": "oral; must be swallowed whole" }, "routeCodes": [ "oral" ], "productCode": "NDC 59011-480-10", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片盐酸羟考酮 80 mg；100 片儿童防开启瓶装；标签注明仅供已建立阿片耐受者", "en": "Oxycodone hydrochloride 80 mg per tablet; 100-tablet child-resistant bottle; label states for opioid-tolerant patients only" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=oxycontin-09.jpg&setid=bfdfe235-d717-4855-a3c8-a13d26dadede&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸羟考酮（每片）", "en": "oxycodone hydrochloride (per tablet)" }, "value": 80, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频率、转换或补服指令", "en": "labelled amount per tablet; not an individual's tablet count, frequency, conversion or missed-use instruction" } } ], "concentration": null, "container": { "typeCode": "child_resistant_bottle", "typeLabel": { "zh": "儿童防开启瓶", "en": "child-resistant bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-30", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "绿色", "en": "green" }, "shape": { "zh": "圆形、双凸、薄膜衣控释片", "en": "round, biconvex, film-coated extended-release tablet" }, "imprint": "OP / 80", "scoreStatus": "not_stated_in_label_whole_tablet_required", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_2b7fe1b4e3f71fd0", "label": "DailyMed（NLM）：OXYCONTIN 盐酸羟考酮控释片当前美国公开标签（Knoa Pharma；SPL v44，2026-06-24 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=bfdfe235-d717-4855-a3c8-a13d26dadede", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-oxycontin-oxycodone-hydrochloride-er-tablet-10mg-100-bottle-ndc-59011-410-10", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=oxycontin-03.jpg&setid=bfdfe235-d717-4855-a3c8-a13d26dadede&type=img", "alt": "OXYCONTIN 盐酸羟考酮控释片 10 mg、NDC 59011-410-10、100 片瓶装在美国 DailyMed 当前标签中的准确包装图", "archiveMarket": "美国", "labelVersion": "DailyMed SPL v44（2026-06-24 生效）", "presentation": "OXYCONTIN 10 mg 控释片；NDC 59011-410-10；100 片儿童防开启瓶装", "notice": "此图只对应所引当前美国标签中的 OXYCONTIN 10 mg、NDC 59011-410-10 和 100 片瓶装。它不用于鉴定真伪，不代表个人适用、片数、频率、换算、减量、停药、购买资格或其他强度/市场包装。", "source": { "id": "src_2b7fe1b4e3f71fd0", "label": "DailyMed（NLM）：OXYCONTIN 盐酸羟考酮控释片当前美国公开标签（Knoa Pharma；SPL v44，2026-06-24 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=bfdfe235-d717-4855-a3c8-a13d26dadede", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "OXYCONTIN 说明书放大阅读：控释片必须整片吞服，先防呼吸抑制与重复镇静", "en": "OXYCONTIN label reading: swallow the extended-release tablet whole and prioritise respiratory-depression and duplicate-sedation risks" }, "summary": { "zh": "本模块放大阅读当前美国标签中的准确控释片、包装、整片边界和高风险药单线索；不决定个人是否使用，也不生成片数、频率、转换、开始、补服、减量或停药方案。", "en": "This module enlarges the exact extended-release tablet, package, whole-tablet boundary and high-risk medicine-list cues in the current U.S. label. It does not decide individual use or generate tablet count, frequency, conversion, initiation, missed-use, tapering or stopping." }, "checks": [ { "zh": "OXYCONTIN 是控释片，必须整片吞服。切开、掰开、咀嚼、碾碎或溶解会破坏控释，可能造成羟考酮快速释放并暴露于潜在致命剂量；片上没有被标签描述为可自行分片的刻痕。吞咽困难时不要自行改造药片，应联系开方团队或药师。", "en": "OXYCONTIN is an extended-release tablet and must be swallowed whole. Cutting, breaking, chewing, crushing or dissolving can defeat the controlled release and expose a person to a potentially fatal oxycodone dose; the label does not describe a self-splitting score. If swallowing is difficult, do not alter the tablet—contact the prescriber or pharmacist." }, { "zh": "严重、危及生命或致命的呼吸抑制可发生，开始使用或调整后尤其需要专业监测。老年、虚弱、慢性肺病、呼吸储备下降者，以及出现异常嗜睡、叫不醒、呼吸慢浅、嘴唇发青或意识改变者风险更值得优先处理；严重表现应立即使用当地急救服务。", "en": "Serious, life-threatening or fatal respiratory depression can occur and requires particular professional monitoring after initiation or change. Older, frail people, those with chronic lung disease or reduced respiratory reserve, and anyone with unusual sleepiness, difficulty waking, slow or shallow breathing, blue lips or altered consciousness need priority attention; severe signs require local emergency services immediately." }, { "zh": "苯二氮卓类安眠/抗焦虑药、其他镇静催眠药、其他阿片、麻醉药、部分抗精神病药、加巴喷丁类药物和酒精等中枢抑制物与 OXYCONTIN 同在药单时，可能增加深度镇静、呼吸抑制、昏迷和死亡风险。不要因服用时间错开就认定安全；请把所有处方药、非处方药、酒精和补充剂放在同一张清单交给医生或药师核对。", "en": "Benzodiazepine sleeping/anxiety medicines, other sedative-hypnotics, other opioids, anaesthetics, some antipsychotics, gabapentinoids and alcohol can increase profound sedation, respiratory depression, coma and death when present with OXYCONTIN. Separating clock times does not establish safety; place every prescription, OTC medicine, alcohol exposure and supplement on one list for a clinician or pharmacist." }, { "zh": "标签把 60 mg、80 mg 以及某些更高暴露情境限定给已建立相应阿片耐受者。‘以前吃过止痛药’、体重、疼痛评分或手中还有旧药，都不能由网页判断为已经耐受；不要自行升级强度、换算另一种阿片或使用他人的药。", "en": "The label restricts 60 mg, 80 mg and certain higher-exposure situations to people with established opioid tolerance. Prior pain-medicine use, body weight, a pain score or leftover tablets cannot let a webpage establish tolerance; do not self-escalate strength, convert another opioid or use another person's medicine." }, { "zh": "儿童或未被开具者意外摄入一片也可能致命。药品应上锁、远离儿童和访客，按当地药品回收或官方处置要求处理；不得分享、转赠或保留在无人管理的位置。若怀疑意外摄入，不要等待症状或网页判断，立即联系当地急救/毒物咨询渠道。", "en": "Accidental ingestion of even one tablet by a child or person for whom it was not prescribed can be fatal. Store it locked away from children and visitors, use local take-back or official disposal routes, and never share, give away or leave it unsecured. If accidental ingestion is suspected, do not wait for symptoms or a webpage—contact local emergency/poison services immediately." }, { "zh": "强 CYP3A4 抑制剂或诱导剂的开始、停用或变化可能改变羟考酮暴露；影响血清素的药可能带来血清素综合征风险；MAO 抑制剂及其近期使用也需要严格核对。不要根据药名类别自行错开、停换或调整任何一种药。", "en": "Starting, stopping or changing a strong CYP3A4 inhibitor or inducer may alter oxycodone exposure; serotonergic medicines may contribute to serotonin syndrome; MAO inhibitors and recent MAO-inhibitor use also require strict review. Do not self-separate, stop, switch or adjust any medicine from a class name." }, { "zh": "便秘、腹胀、呕吐或疑似肠梗阻需要及时评估；已知或疑似胃肠道梗阻是标签禁忌。网页不能区分普通便秘、阿片相关问题或急腹症，也不能代替临床检查。", "en": "Constipation, distension, vomiting or suspected obstruction needs prompt assessment; known or suspected gastrointestinal obstruction is a labelled contraindication. A webpage cannot distinguish ordinary constipation, an opioid-related problem or an acute abdomen and cannot replace examination." }, { "zh": "纳洛酮可用于阿片过量紧急处置，但是否需要配备、如何获得和怎样使用应由当地医疗或药学团队结合具体情况讲解。出现叫不醒、呼吸异常或疑似过量时，应立即呼叫当地急救服务，不要只依赖网页或家属观察。", "en": "Naloxone can be used in an opioid-overdose emergency, but whether to have it, how to obtain it and how to use it requires local clinical or pharmacy instruction. If a person cannot be awakened, has abnormal breathing or an overdose is suspected, call local emergency services immediately rather than relying only on a webpage or household observation." } ], "source": { "id": "src_2b7fe1b4e3f71fd0", "label": "DailyMed（NLM）：OXYCONTIN 盐酸羟考酮控释片当前美国公开标签（Knoa Pharma；SPL v44，2026-06-24 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=bfdfe235-d717-4855-a3c8-a13d26dadede", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "羟考酮怎样起作用：阿片受体激动与控释技术不能变成个人换算规则", "en": "How oxycodone works: opioid-receptor agonism and extended release are not personal conversion rules" }, "summary": { "zh": "当前标签把羟考酮描述为阿片受体激动剂，并把 OXYCONTIN 设计为控释片。药理和释放方式可以解释镇痛、嗜睡、呼吸抑制、便秘与依赖风险，却不能推导个人应服几片、与另一种阿片如何换算、能否掰片或何时减停。", "en": "The current label describes oxycodone as an opioid agonist and OXYCONTIN as an extended-release tablet. Pharmacology and release design help explain analgesia, sedation, respiratory depression, constipation and dependence risk, but cannot derive an individual's tablet count, conversion from another opioid, splitting or taper/stopping timing." }, "checks": [ { "zh": "“控释”表示药片释放设计是产品身份的一部分，不等于药效更温和或风险更低；破坏药片可把释放特性变成危险暴露。", "en": "Extended release means the release design is part of product identity; it does not mean milder effects or lower risk. Altering the tablet can turn its release characteristics into dangerous exposure." }, { "zh": "共同成分或同属阿片类不表示 OXYCONTIN 与普通羟考酮、复方羟考酮、芬太尼贴剂、吗啡或另一控释产品可按毫克自行替换、叠加或轮换。", "en": "A shared ingredient or opioid class does not make OXYCONTIN self-convertible, combinable or alternatable by milligrams with immediate-release oxycodone, an oxycodone combination, fentanyl patch, morphine or another extended-release product." }, { "zh": "出现疼痛加重、异常嗜睡、呼吸变化、跌倒、意识变化或戒断样不适时，机制页不能判断原因。不要同时改变多种药，应联系开方团队；急性严重表现使用当地急救服务。", "en": "A mechanism page cannot determine the cause of worsening pain, unusual sleepiness, breathing change, a fall, altered consciousness or withdrawal-like symptoms. Do not change several medicines at once; contact the prescribing team and use local emergency services for acute severe signs." } ], "source": { "id": "src_2b7fe1b4e3f71fd0", "label": "DailyMed（NLM）：OXYCONTIN 盐酸羟考酮控释片当前美国公开标签（Knoa Pharma；SPL v44，2026-06-24 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=bfdfe235-d717-4855-a3c8-a13d26dadede", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "OXYCONTIN", "generic": "盐酸羟考酮控释片", "dosageFormClass": "盐酸羟考酮薄膜衣控释片；必须整片吞服。不得切开、掰开、咀嚼、碾碎或溶解；普通羟考酮、羟考酮/对乙酰氨基酚复方、另一种羟考酮控释胶囊和历史原配方均不并入本档案。" }, "labelSource": { "id": "src_2b7fe1b4e3f71fd0", "label": "DailyMed（NLM）：OXYCONTIN 盐酸羟考酮控释片当前美国公开标签（Knoa Pharma；SPL v44，2026-06-24 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=bfdfe235-d717-4855-a3c8-a13d26dadede", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "productRoutes": [ { "source": { "id": "src_2b7fe1b4e3f71fd0", "label": "DailyMed（NLM）：OXYCONTIN 盐酸羟考酮控释片当前美国公开标签（Knoa Pharma；SPL v44，2026-06-24 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=bfdfe235-d717-4855-a3c8-a13d26dadede", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "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": "2026-08-30", "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": "2026-08-30", "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": "OXYCONTIN 是盐酸羟考酮控释片，是美国 CII 管制的长效阿片类处方药。最重要的三件事是：它不是普通速释羟考酮，也不是临时按需止痛药；必须整片吞服，破坏控释片可能一次释放潜在致命剂量；与酒精、安眠镇静药或其他抑制中枢的药同在一张药单时，嗜睡和呼吸抑制风险必须由专业人员核对。网页只帮助识别包装、说明书和风险，不提供个人片数、频率、换算、减量或停药方案。", "history": "FDA 2010 年 NDA 022272 医学审评资料记录了抗滥用重配方 OXYCONTIN 的监管背景，并与历史原配方 NDA 020553 分开。当前 DailyMed SPL v44 于 2026-06-24 生效，列示 10、15、20、30、40、60、80 mg 七种控释片；标签所列 Initial U.S. Approval: 1950 指羟考酮成分的美国初始批准节点，不能写成 OXYCONTIN 品牌于 1950 年获批。", "sourceDocuments": [ { "id": "src_2b7fe1b4e3f71fd0", "label": "DailyMed（NLM）：OXYCONTIN 盐酸羟考酮控释片当前美国公开标签（Knoa Pharma；SPL v44，2026-06-24 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=bfdfe235-d717-4855-a3c8-a13d26dadede", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, { "id": "src_240f6a672cb5e35b", "label": "FDA：OXYCONTIN 现行重配方 NDA 022272 医学审评资料（2010）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022272s000MedR.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "regulatory_review", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } ], "applicationNumber": "FDA NDA 022272（当前重配方 OXYCONTIN）", "approvalTimeline": [ { "date": "1950", "title": { "zh": "羟考酮的美国初始批准年份", "en": "Initial U.S. approval year for oxycodone" }, "detail": { "zh": "当前标签列出 Initial U.S. Approval: 1950；该年份属于活性成分历史，不写成 OXYCONTIN 品牌或当前重配方的批准年份。", "en": "The current label states Initial U.S. Approval: 1950; this is active-ingredient history and is not presented as the approval year for the OXYCONTIN brand or current reformulation." }, "source": { "id": "src_2b7fe1b4e3f71fd0", "label": "DailyMed（NLM）：OXYCONTIN 盐酸羟考酮控释片当前美国公开标签（Knoa Pharma；SPL v44，2026-06-24 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=bfdfe235-d717-4855-a3c8-a13d26dadede", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } }, { "date": "2010", "title": { "zh": "当前重配方 NDA 022272 审评节点", "en": "Current reformulation NDA 022272 review milestone" }, "detail": { "zh": "FDA 医学审评资料将 NDA 022272 的重配方与历史原配方 NDA 020553 分开，并说明其提高抗物理/化学篡改能力的监管背景。", "en": "FDA medical-review material distinguishes the NDA 022272 reformulation from historical original formulation NDA 020553 and describes its greater resistance to physical and chemical manipulation." }, "source": { "id": "src_240f6a672cb5e35b", "label": "FDA：OXYCONTIN 现行重配方 NDA 022272 医学审评资料（2010）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022272s000MedR.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "regulatory_review", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } }, { "date": "2026-06-24", "title": { "zh": "当前公开标签生效", "en": "Current public label effective" }, "detail": { "zh": "DailyMed SPL v44 列示七种强度、十四个 NDC（瓶装与单位剂量包装）及现行安全信息；本页只逐一展示七个 100 片瓶装。", "en": "DailyMed SPL v44 lists seven strengths, fourteen NDCs (bottles and unit-dose packs) and current safety information; this page maps only the seven 100-tablet bottles one to one." }, "source": { "id": "src_2b7fe1b4e3f71fd0", "label": "DailyMed（NLM）：OXYCONTIN 盐酸羟考酮控释片当前美国公开标签（Knoa Pharma；SPL v44，2026-06-24 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=bfdfe235-d717-4855-a3c8-a13d26dadede", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "当前 NDA 标签和七个准确瓶装面板已建立", "en": "Current NDA label and seven exact bottle panels established" }, "detail": { "zh": "准确标签和 NDC 不等于实际库存、购买资格、个人适用性或可替代性。", "en": "An exact label and NDC do not establish actual stock, purchase eligibility, individual suitability or interchangeability." } }, { "market": { "zh": "中国大陆及其他市场", "en": "Mainland China and other markets" }, "status": { "zh": "现行监管记录待逐项建立", "en": "Current regulatory records not yet established" }, "detail": { "zh": "不从美国商品名、共同成分或包装外观推定当地批准、商品名、供应、原研/仿制关系或合法购药渠道。", "en": "No local approval, trade name, supply, originator/generic relationship or lawful purchase channel is inferred from the U.S. name, shared ingredient or package appearance." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "药片太大，可以掰开或碾碎吗？", "en": "Can a large tablet be split or crushed?" }, "answer": { "zh": "不可以根据网页或外观自行这样做。当前标签要求整片吞服；切开、掰开、咀嚼、碾碎或溶解可能释放潜在致命剂量。吞咽困难应立即联系开方团队或药师讨论安全替代方案。", "en": "Do not do this from a webpage or appearance. The current label requires swallowing whole; cutting, breaking, chewing, crushing or dissolving may release a potentially fatal dose. Contact the prescriber or pharmacist promptly about a safe alternative if swallowing is difficult." } }, { "question": { "zh": "晚上再吃安眠药，错开时间就安全吗？", "en": "Is a sleeping medicine safe if taken at a different time?" }, "answer": { "zh": "网页不能这样判断。苯二氮卓类、其他镇静药、酒精和其他中枢抑制物可能与 OXYCONTIN 共同增加深度镇静、呼吸抑制、昏迷和死亡风险；错开时间本身不证明安全，应核对完整药单。", "en": "A webpage cannot establish that. Benzodiazepines, other sedatives, alcohol and other CNS depressants may add to profound sedation, respiratory depression, coma and death with OXYCONTIN; separating times does not prove safety, so the full list needs review." } }, { "question": { "zh": "10 mg 和 20 mg 看起来只差一倍，可以自行换算片数吗？", "en": "Can 10 mg and 20 mg be converted by tablet count because one is double?" }, "answer": { "zh": "不能。标签强度是每片产品身份，不是个人换算器。阿片转换、耐受、合并用药、肝肾/肺部状况和停药风险都需专业评估；不要自行叠加、减半、轮换或使用他人的药。", "en": "No. Labelled strength is a per-tablet identity, not a personal converter. Opioid conversion, tolerance, co-medication, hepatic/renal/pulmonary status and stopping risk require professional assessment; do not self-combine, halve, alternate or use another person's medicine." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dosage-forms-are-part-of-medicine-identity", "polypharmacy-safety-guide", "family-medicine-list-for-pharmacist" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/oxycontin/", "en": "https://origindrug.com/en/drugs/oxycontin/" }, "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." ] }