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。
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 |
|---|---|---|---|---|---|---|
Tresiba insulin degludec | 0169-2550 | INJECTION, SOLUTION | SUBCUTANEOUS | INSULIN DEGLUDEC 200 U/mL | Novo Nordisk | BLA |
Insulin lispro Insulin lispro | 62381-9516 | INJECTION, SOLUTION | — | INSULIN LISPRO 100 [iU]/mL | Lilly France | DRUG FOR FURTHER PROCESSING |
Insulin Lispro Insulin lispro | 50090-5391 | INJECTION, SOLUTION | INTRAVENOUS、SUBCUTANEOUS | INSULIN LISPRO 100 [iU]/mL | A-S Medication Solutions | BLA |
LYUMJEV KwikPen Insulin lispro-aabc | 0002-8207 | INJECTION, SOLUTION | SUBCUTANEOUS | INSULIN LISPRO 100 [iU]/mL | Eli Lilly and Company | BLA |
NOVOLOG insulin aspart | 0169-2101 | INJECTION, SOLUTION | INTRAVENOUS、SUBCUTANEOUS | INSULIN ASPART 100 [iU]/mL | Novo Nordisk | BLA |
ADMELOG insulin lispro | 0024-5924 | INJECTION, SOLUTION | INTRAVENOUS、SUBCUTANEOUS | INSULIN LISPRO 100 U/mL | Sanofi-Aventis U.S. LLC | BLA |
Insulin Lispro KwikPen Insulin lispro | 0002-8222 | INJECTION, SOLUTION | INTRAVENOUS、SUBCUTANEOUS | INSULIN LISPRO 100 [iU]/mL | Eli Lilly and Company | BLA |
Humulin N Insulin human | 0002-8805 | INJECTION, SUSPENSION | SUBCUTANEOUS | INSULIN HUMAN 100 [iU]/mL | Eli Lilly and Company | BLA |
LYUMJEV Tempo Pen Insulin lispro-aabc | 0002-8235 | INJECTION, SOLUTION | SUBCUTANEOUS | INSULIN LISPRO 100 [iU]/mL | Eli Lilly and Company | BLA |
NovoLog Mix 70/30 insulin aspart | 0169-2200 | INJECTION, SUSPENSION | SUBCUTANEOUS | INSULIN ASPART 100 [iU]/mL | Novo Nordisk Pharmaceutical Industries, LP | BLA |
TRESIBA insulin degludec | 50090-7094 | INJECTION, SOLUTION | SUBCUTANEOUS | INSULIN DEGLUDEC 200 U/mL | A-S Medication Solutions | BLA |
Humalog Mix50/50 KwikPen Insulin lispro | 0002-8798 | INJECTION, SUSPENSION | SUBCUTANEOUS | INSULIN LISPRO 100 [iU]/mL | Eli Lilly and Company | BLA |
REZVOGLAR KWIKPEN Insulin glargine-aglr | 50090-6439 | INJECTION, SOLUTION | SUBCUTANEOUS | INSULIN GLARGINE 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 | BULK INGREDIENT |
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 | 0169-2201 | INJECTION, SUSPENSION | SUBCUTANEOUS | INSULIN ASPART 100 [iU]/mL | Novo Nordisk Pharmaceutical Industries, LP | BLA |
Insulin 1556 Insulin | 63083-1556 | LIQUID | ORAL | INSULIN GLARGINE 9 [hp_X]/29.5mL | Professional Complementary Health Formulas | UNAPPROVED HOMEOPATHIC |
Lantus insulin glargine | 50090-0876 | INJECTION, SOLUTION | SUBCUTANEOUS | INSULIN GLARGINE 100 [iU]/mL | A-S Medication Solutions | BLA |
D-136 somatropin, long-(arg3)insulin-like growth factor-i, arsenic trioxide, saw palmetto, platinum, oyster shell calcium carbonate, crude, bos taurus adrenal cortex, bos taurus pituitary gland, posterior, thyroid, unspecified, and bos taurus hypothalamus | 58264-0145 | SOLUTION | SUBLINGUAL | SOMATROPIN 12 [hp_X]/mL；LONG-(ARG3)INSULIN-LIKE GROWTH FACTOR-I 12 [hp_X]/mL；ARSENIC TRIOXIDE 6 [hp_X]/mL；SAW PALMETTO 12 [hp_X]/mL；PLATINUM 30 [hp_X]/mL；OYSTER SHELL CALCIUM CARBONATE, CRUDE 12 [hp_X]/mL；BOS TAURUS ADRENAL CORTEX 12 [hp_X]/mL；BOS TAURUS PITUITARY GLAND, POSTERIOR 12 [hp_X]/mL；THYROID, UNSPECIFIED 12 [hp_X]/mL；BOS TAURUS HYPOTHALAMUS 12 [hp_X]/mL | DNA Labs, Inc. | UNAPPROVED HOMEOPATHIC |
AFREZZA INSULIN HUMAN | 47918-874 | POWDER, METERED | RESPIRATORY (INHALATION) | INSULIN HUMAN 4 [arb'U]/1 | Mannkind Corporation | BLA |
LYUMJEV Insulin lispro-aabc | 50090-7433 | INJECTION, SOLUTION | INTRAVENOUS、SUBCUTANEOUS | INSULIN LISPRO 100 [iU]/mL | A-S Medication Solutions | BLA |
AFREZZA INSULIN HUMAN | 47918-878 | POWDER, METERED | RESPIRATORY (INHALATION) | INSULIN HUMAN 8 [arb'U]/1 | Mannkind Corporation | BLA |
AFREZZA INSULIN HUMAN | 47918-880 | KIT | RESPIRATORY (INHALATION) | — | Mannkind Corporation | BLA |
AFREZZA INSULIN HUMAN | 47918-891 | POWDER, METERED | RESPIRATORY (INHALATION) | INSULIN HUMAN 12 [arb'U]/1 | Mannkind Corporation | BLA |
Humalog Mix75/25 Insulin lispro | 0002-7511 | INJECTION, SUSPENSION | SUBCUTANEOUS | INSULIN LISPRO 100 [iU]/mL | Eli Lilly and Company | BLA |
Tresiba insulin degludec | 0169-2660 | INJECTION, SOLUTION | SUBCUTANEOUS | INSULIN DEGLUDEC 100 U/mL | Novo Nordisk | BLA |
AFREZZA INSULIN HUMAN | 47918-898 | KIT | RESPIRATORY (INHALATION) | — | Mannkind Corporation | BLA |
AFREZZA INSULIN HUMAN | 47918-902 | KIT | RESPIRATORY (INHALATION) | — | Mannkind Corporation | BLA |
DNA Insulin Drops 2019 DNA Insulin Drops | 63083-2019 | LIQUID | ORAL | CHROMIUM 6 [hp_X]/59mL；LYCOPODIUM CLAVATUM SPORE 6 [hp_X]/59mL；VANADIUM 6 [hp_X]/59mL；PANCRELIPASE AMYLASE 6 [hp_X]/59mL；INSULIN GLULISINE 12 [hp_X]/59mL；PHOSPHORIC ACID 30 [hp_X]/59mL；URANYL NITRATE HEXAHYDRATE 30 [hp_X]/59mL；RADIUM BROMIDE 60 [hp_X]/59mL | Professional Complementary Health Formulas | UNAPPROVED HOMEOPATHIC |
AFREZZA INSULIN HUMAN | 47918-904 | KIT | RESPIRATORY (INHALATION) | — | Mannkind Corporation | BLA |
Rezvoglar KwikPen Insulin glargine-aglr | 0002-8980 | INJECTION, SOLUTION | SUBCUTANEOUS | INSULIN GLARGINE 100 [iU]/mL | Eli Lilly and Company | BLA |
Panacode Syzygium, Hydrastis, Adrenalinum, Pancreatinum, Pituitarum Posterium, Bovista, Insulin, Lycopersicum, Phosphoricum Ac, Phosphorus, Tarentula Hispana, Terebinthina, Uranium Nitricum | 43406-0686 | LIQUID | ORAL | SYZYGIUM CUMINI SEED 4 [hp_X]/mL；GOLDENSEAL 6 [hp_X]/mL；EPINEPHRINE 9 [hp_X]/mL；PANCRELIPASE 9 [hp_X]/mL；SUS SCROFA PITUITARY GLAND, POSTERIOR 9 [hp_X]/mL；LYCOPERDON UTRIFORME FRUITING BODY 12 [hp_X]/mL；INSULIN PORK 12 [hp_X]/mL；SOLANUM LYCOPERSICUM WHOLE 12 [hp_X]/mL；PHOSPHORIC ACID 12 [hp_X]/mL；PHOSPHORUS 12 [hp_X]/mL；LYCOSA TARANTULA 12 [hp_X]/mL；TURPENTINE OIL 12 [hp_X]/mL；URANYL NITRATE HEXAHYDRATE 12 [hp_X]/mL | Natural Creations, Inc | UNAPPROVED HOMEOPATHIC |
Tresiba insulin degludec | 0169-2662 | INJECTION, SOLUTION | SUBCUTANEOUS | INSULIN DEGLUDEC 100 U/mL | Novo Nordisk | BLA |
INSULIN GLARGINE insulin glargine-yfgn | 72572-422 | INJECTION, SOLUTION | SUBCUTANEOUS | INSULIN GLARGINE 100 [iU]/mL | Civica, Inc. | BLA |
INSULIN GLARGINE insulin glargine-yfgn | 72572-424 | INJECTION, SOLUTION | SUBCUTANEOUS | INSULIN GLARGINE 100 [iU]/mL | Civica, Inc. | BLA |
TOUJEO Max insulin glargine | 0024-5871 | INJECTION, SOLUTION | SUBCUTANEOUS | INSULIN GLARGINE 300 U/mL | Sanofi-Aventis U.S. LLC | BLA |
BASAGLAR KwikPen Insulin glargine | 0002-7715 | INJECTION, SOLUTION | SUBCUTANEOUS | INSULIN GLARGINE 100 [iU]/mL | Eli Lilly and Company | BLA |
Insulin Degludec insulin degludec | 50090-7175 | INJECTION, SOLUTION | SUBCUTANEOUS | INSULIN DEGLUDEC 200 U/mL | A-S Medication Solutions | BLA |
Insulin Degludec insulin degludec | 50090-7176 | INJECTION, SOLUTION | SUBCUTANEOUS | INSULIN DEGLUDEC 100 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 |
ADMELOG insulin lispro | 70518-4275 | INJECTION, SOLUTION | SUBCUTANEOUS | INSULIN LISPRO 100 U/mL | REMEDYREPACK INC. | BLA |
TOUJEO insulin glargine | 50090-2193 | INJECTION, SOLUTION | SUBCUTANEOUS | INSULIN GLARGINE 300 U/mL | A-S Medication Solutions | BLA |
Insulin Lispro Insulin lispro | 0002-7737 | INJECTION, SOLUTION | INTRAVENOUS、SUBCUTANEOUS | INSULIN LISPRO 100 [iU]/mL | Eli Lilly and Company | BLA |
Insulin Insulin | 82196-020 | POWDER | — | INSULIN HUMAN 28.5 mg/g | Biocon Biologics Limited | BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING |
ONSWIK KwikPen insulin efsitora alfa-gobe | 0002-5240 | INJECTION, SOLUTION | SUBCUTANEOUS | INSULIN EFSITORA ALFA 1000 [iU]/mL | Eli Lilly and Company | BLA |
Insulin Aspart insulin aspart | 70518-3865 | INJECTION, SOLUTION | INTRAVENOUS、SUBCUTANEOUS | INSULIN ASPART 100 [iU]/mL | REMEDYREPACK INC. | BLA |
Xultophy 100/3.6 insulin degludec and liraglutide | 0169-2911 | INJECTION, SOLUTION | SUBCUTANEOUS | INSULIN DEGLUDEC 100 [iU]/mL；LIRAGLUTIDE 3.6 mg/mL | Novo Nordisk | BLA |
NOVOLOG insulin aspart | 0169-7501 | INJECTION, SOLUTION | INTRAVENOUS、SUBCUTANEOUS | INSULIN ASPART 100 [iU]/mL | Novo Nordisk | BLA |
MERILOG insulin aspart-szjj | 0024-5927 | INJECTION, SOLUTION | INTRAVENOUS、SUBCUTANEOUS | INSULIN ASPART 100 [iU]/mL | Sanofi-Aventis U.S. LLC | BLA |
Insulin Aspart Protamine and Insulin Aspart Mix 70/30 insulin aspart | 70518-3236 | INJECTION, SUSPENSION | SUBCUTANEOUS | INSULIN ASPART 100 [iU]/mL | REMEDYREPACK INC. | 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。