FDA 药品与器械查询

实时对接美国 FDA 官方开放数据（openFDA），可查询美国上市药品 NDC 目录、医疗器械管理类别与 21 CFR 法规号、以及已获许可的 510(k) 清单，用于出海美国的准入判断、注册路径选择与同类竞品调研。支持中文关键词自动转英文检索。

数据源：美国 FDA 官方开放数据平台 openFDA，实时查询美国上市药品 NDC 目录、器械分类与 510(k) 许可，用于出海美国的准入与合规自查。

支持中文关键词自动转英文检索；此为美国监管口径，与中国 NMPA 批准情况相互独立。

上市药品（NDC）器械分类 510(k) 许可

查询美国市场在售药品：剂型、给药途径、活性成分、持证商与 NDC 编码，用于判断目标品种在美国是否已有同类上市。

已将中文关键词转为英文「insulin」检索 FDA 数据库。

共找到 220 条与「insulin」匹配的结果

当前展示 50 条美国 FDA 上市药品记录；海关数据库提供全球买卖明细与竞争对手出货记录咨询完整数据 ›

药品名称	NDC 编码	剂型	给药途径	活性成分	持证商	上市类别
Humalog Mix75/25 Insulin lispro	0002-7511	INJECTION, SUSPENSION	SUBCUTANEOUS	INSULIN LISPRO 100 [iU]/mL	Eli Lilly and Company	BLA
Insulin Degludec insulin degludec	73070-403	INJECTION, SOLUTION	SUBCUTANEOUS	INSULIN DEGLUDEC 100 U/mL	Novo Nordisk Pharma, Inc.	BLA
Insulin Aspart Protamine and Insulin Aspart Mix 70/30 insulin aspart	73070-200	INJECTION, SUSPENSION	SUBCUTANEOUS	INSULIN ASPART 100 [iU]/mL	Novo Nordisk Pharma, Inc.	BLA
Insulin Aspart Protamine and Insulin Aspart Mix 70/30 insulin aspart	73070-203	INJECTION, SUSPENSION	SUBCUTANEOUS	INSULIN ASPART 100 [iU]/mL	Novo Nordisk Pharma, Inc.	BLA
Apidra SoloStar insulin glulisine	0088-2502	INJECTION, SOLUTION	SUBCUTANEOUS	INSULIN GLULISINE 100 [iU]/mL	sanofi-aventis U.S. LLC	BLA
Insulin Degludec insulin degludec	73070-400	INJECTION, SOLUTION	SUBCUTANEOUS	INSULIN DEGLUDEC 100 U/mL	Novo Nordisk Pharma, Inc.	BLA
Insulin Lispro KwikPen Insulin lispro	0002-8222	INJECTION, SOLUTION	INTRAVENOUS、SUBCUTANEOUS	INSULIN LISPRO 100 [iU]/mL	Eli Lilly and Company	BLA
Insulin Degludec insulin degludec	50090-7176	INJECTION, SOLUTION	SUBCUTANEOUS	INSULIN DEGLUDEC 100 U/mL	A-S Medication Solutions	BLA
INSULIN DILUTING MEDIUM FOR Kirsty water	83257-006	INJECTION, SOLUTION	INTRAVENOUS、SUBCUTANEOUS	WATER 1 mL/mL	Biocon Biologics Inc.	BLA
KIRSTY insulin aspart-xjhz	83257-007	INJECTION, SOLUTION	INTRAVENOUS、SUBCUTANEOUS	INSULIN ASPART 100 [iU]/mL	Biocon Biologics Inc.	BLA
Insulin Diluting Medium for NovoLog water injection	0169-2001	INJECTION, SOLUTION	INTRAVENOUS、SUBCUTANEOUS	WATER 1 mL/mL	Novo Nordisk	BLA
Fiasp insulin aspart injection	0169-3205	INJECTION, SOLUTION	SUBCUTANEOUS	INSULIN ASPART 100 [iU]/mL	Novo Nordisk	BLA
KIRSTY insulin aspart-xjhz	83257-008	INJECTION, SOLUTION	INTRAVENOUS、SUBCUTANEOUS	INSULIN ASPART 100 [iU]/mL	Biocon Biologics Inc.	BLA
Insulin lispro Insulin lispro	62381-9516	INJECTION, SOLUTION	—	INSULIN LISPRO 100 [iU]/mL	Lilly France	DRUG FOR FURTHER PROCESSING
Insulin Degludec insulin degludec	50090-7175	INJECTION, SOLUTION	SUBCUTANEOUS	INSULIN DEGLUDEC 200 U/mL	A-S Medication Solutions	BLA
Tresiba insulin degludec	50090-3491	INJECTION, SOLUTION	SUBCUTANEOUS	INSULIN DEGLUDEC 200 U/mL	A-S Medication Solutions	BLA
SEMGLEE insulin glargine-yfgn	83257-011	INJECTION, SOLUTION	SUBCUTANEOUS	INSULIN GLARGINE 100 [iU]/mL	Biocon Biologics Inc.	BLA
SEMGLEE insulin glargine-yfgn	83257-012	INJECTION, SOLUTION	SUBCUTANEOUS	INSULIN GLARGINE 100 [iU]/mL	Biocon Biologics Inc.	BLA
Insulin Glargine insulin Glargine-yfgn	83257-014	INJECTION, SOLUTION	SUBCUTANEOUS	INSULIN GLARGINE 100 [iU]/mL	Biocon Biologics Inc.	BLA
LYUMJEV Tempo Pen Insulin lispro-aabc	0002-8235	INJECTION, SOLUTION	SUBCUTANEOUS	INSULIN LISPRO 100 [iU]/mL	Eli Lilly and Company	BLA
Lantus Solostar insulin glargine	0088-2219	INJECTION, SOLUTION	SUBCUTANEOUS	INSULIN GLARGINE 100 [iU]/mL	sanofi-aventis U.S. LLC	BLA
TOUJEO insulin glargine	50090-2193	INJECTION, SOLUTION	SUBCUTANEOUS	INSULIN GLARGINE 300 U/mL	A-S Medication Solutions	BLA
Insulin Glargine insulin Glargine-yfgn	83257-015	INJECTION, SOLUTION	SUBCUTANEOUS	INSULIN GLARGINE 100 [iU]/mL	Biocon Biologics Inc.	BLA
Fiasp insulin aspart	0169-3206	INJECTION, SOLUTION	SUBCUTANEOUS	INSULIN ASPART 100 [iU]/mL	Novo Nordisk	BLA
Humalog Mix50/50 KwikPen Insulin lispro	0002-8798	INJECTION, SUSPENSION	SUBCUTANEOUS	INSULIN LISPRO 100 [iU]/mL	Eli Lilly and Company	BLA
NOVOLOG insulin aspart	0169-3303	INJECTION, SOLUTION	INTRAVENOUS、SUBCUTANEOUS	INSULIN ASPART 100 [iU]/mL	Novo Nordisk	BLA
Lantus insulin glargine	0088-2220	INJECTION, SOLUTION	SUBCUTANEOUS	INSULIN GLARGINE 100 [iU]/mL	sanofi-aventis U.S. LLC	BLA
Humulin N Insulin human	0002-8805	INJECTION, SUSPENSION	SUBCUTANEOUS	INSULIN HUMAN 100 [iU]/mL	Eli Lilly and Company	BLA
Apidra insulin glulisine	0088-2500	INJECTION, SOLUTION	INTRAVENOUS、SUBCUTANEOUS	INSULIN GLULISINE 100 [iU]/mL	sanofi-aventis U.S. LLC	BLA
Recombinant Human Insulin Recombinant Human Insulin	69098-101	POWDER	—	INSULIN HUMAN 1 g/g	Amphastar France Pharmaceuticals	BULK INGREDIENT
NovoLog Mix 70/30 insulin aspart	50090-2272	INJECTION, SUSPENSION	SUBCUTANEOUS	INSULIN ASPART 100 [iU]/mL	A-S Medication Solutions	BLA
Recombinant Human Insulin Recombinant Human Insulin	69098-101	POWDER	—	INSULIN HUMAN 1 g/g	Amphastar France Pharmaceuticals, Inc.	BULK INGREDIENT
NovoLog Mix 70/30 insulin aspart	0169-3685	INJECTION, SUSPENSION	SUBCUTANEOUS	INSULIN ASPART 100 [iU]/mL	Novo Nordisk Pharmaceutical Industries, LP	BLA
Insulin Aspart insulin aspart	73070-103	INJECTION, SOLUTION	INTRAVENOUS、SUBCUTANEOUS	INSULIN ASPART 100 [iU]/mL	Novo Nordisk Pharma, Inc.	BLA
Insulin Aspart insulin aspart	73070-100	INJECTION, SOLUTION	INTRAVENOUS、SUBCUTANEOUS	INSULIN ASPART 100 [iU]/mL	Novo Nordisk Pharma, Inc.	BLA
Insulin Aspart insulin aspart	73070-102	INJECTION, SOLUTION	INTRAVENOUS、SUBCUTANEOUS	INSULIN ASPART 100 [iU]/mL	Novo Nordisk Pharma, Inc.	BLA
NOVOLOG insulin aspart	0169-6339	INJECTION, SOLUTION	INTRAVENOUS、SUBCUTANEOUS	INSULIN ASPART 100 [iU]/mL	Novo Nordisk	BLA
Insulin Aspart insulin aspart	50090-4956	INJECTION, SOLUTION	INTRAVENOUS、SUBCUTANEOUS	INSULIN ASPART 100 [iU]/mL	A-S Medication Solutions	BLA
Garzulys insulin aspart-fsan	71288-904	INJECTION, SOLUTION	INTRAVENOUS、SUBCUTANEOUS	INSULIN ASPART 100 [iU]/mL	Meitheal Pharmaceuticals Inc.	BLA
Insulin Aspart insulin aspart	50090-4955	INJECTION, SOLUTION	INTRAVENOUS、SUBCUTANEOUS	INSULIN ASPART 100 [iU]/mL	A-S Medication Solutions	BLA
Garzulys insulin aspart-fsan	71288-903	INJECTION, SOLUTION	SUBCUTANEOUS	INSULIN ASPART 100 [iU]/mL	Meitheal Pharmaceuticals Inc.	BLA
BASAGLAR KwikPen Insulin glargine	0002-7715	INJECTION, SOLUTION	SUBCUTANEOUS	INSULIN GLARGINE 100 [iU]/mL	Eli Lilly and Company	BLA
.Insulin Aspart Protamine and Insulin Aspart insulin aspart	50090-4959	INJECTION, SUSPENSION	SUBCUTANEOUS	INSULIN ASPART 100 [iU]/mL	A-S Medication Solutions	BLA
Insulin Diluting Medium for Garzulys water injection	71288-909	INJECTION, SOLUTION	INTRAVENOUS、SUBCUTANEOUS	WATER 1 mL/mL	Meitheal Pharmaceuticals Inc.	BLA
Levemir insulin detemir	50090-1276	INJECTION, SOLUTION	SUBCUTANEOUS	INSULIN DETEMIR 100 [iU]/mL	A-S Medication Solutions	BLA
TOUJEO insulin glargine	0024-5869	INJECTION, SOLUTION	SUBCUTANEOUS	INSULIN GLARGINE 300 U/mL	Sanofi-Aventis U.S. LLC	BLA
Rezvoglar KwikPen Insulin glargine-aglr	0002-8980	INJECTION, SOLUTION	SUBCUTANEOUS	INSULIN GLARGINE 100 [iU]/mL	Eli Lilly and Company	BLA
Insulin Lispro Insulin lispro	0002-7737	INJECTION, SOLUTION	INTRAVENOUS、SUBCUTANEOUS	INSULIN LISPRO 100 [iU]/mL	Eli Lilly and Company	BLA
HUMALOG Insulin lispro	50090-1375	INJECTION, SOLUTION	INTRAVENOUS、SUBCUTANEOUS	INSULIN LISPRO 100 [iU]/mL	A-S Medication Solutions	BLA
NOVOLOG insulin aspart	0169-2100	INJECTION, SOLUTION	INTRAVENOUS、SUBCUTANEOUS	INSULIN ASPART 100 [iU]/mL	Novo Nordisk	BLA

数据随 FDA 官方库更新，仅供参考，不构成医学或法律建议；正式注册与报关请以 FDA 官方文件及最新法规为准。

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