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「metformin」检索 FDA 数据库。
共找到 742 条与「metformin」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 |
|---|---|---|---|---|---|---|
Jentadueto XR linagliptin and metformin hydrochloride | 0597-0275 | TABLET, FILM COATED, EXTENDED RELEASE | ORAL | LINAGLIPTIN 5 mg/1；METFORMIN HYDROCHLORIDE 1000 mg/1 | Boehringer Ingelheim Pharmaceuticals, Inc. | NDA |
Sitagliptin Phosphate/Metformin Hydrochloride Extended Sitagliptin Phosphate/Metformin Hydrochloride Extended | 70293-0003 | TABLET, FILM COATED, EXTENDED RELEASE | — | METFORMIN HYDROCHLORIDE 1000 mg/1；SITAGLIPTIN PHOSPHATE 100 mg/1 | AIAC International Pharma, LLC | DRUG FOR FURTHER PROCESSING |
Metformin Hydrochloride | 72789-454 | TABLET, EXTENDED RELEASE | ORAL | METFORMIN HYDROCHLORIDE 500 mg/1 | PD-Rx Pharmaceuticals, Inc. | ANDA |
Metformin Hydrochloride | 42385-947 | TABLET, FILM COATED | ORAL | METFORMIN HYDROCHLORIDE 500 mg/1 | Laurus Labs Limited | ANDA |
METFORMIN HYDROCHLORIDE metformin hydrochloride | 50090-7116 | TABLET, EXTENDED RELEASE | ORAL | METFORMIN HYDROCHLORIDE 500 mg/1 | A-S Medication Solutions | ANDA |
Metformin Hydrochloride | 66689-318 | SOLUTION | ORAL | METFORMIN HYDROCHLORIDE 500 mg/5mL | VistaPharm, LLC | ANDA |
Metformin HCl | 70518-4479 | TABLET | ORAL | METFORMIN HYDROCHLORIDE 850 mg/1 | REMEDYREPACK INC. | ANDA |
METFORMIN HYDROCHLORIDE metformin hydrochloride | 72789-455 | TABLET, EXTENDED RELEASE | ORAL | METFORMIN HYDROCHLORIDE 500 mg/1 | PD-Rx Pharmaceuticals, Inc. | ANDA |
Metformin Hydrochloride Metformin Hydrochloride | 62207-012 | POWDER | — | METFORMIN HYDROCHLORIDE 50 kg/50kg | Granules India Limited | BULK INGREDIENT |
Metformin Hydrochloride | 42385-948 | TABLET, FILM COATED | ORAL | METFORMIN HYDROCHLORIDE 850 mg/1 | Laurus Labs Limited | ANDA |
Metformin Hydrochloride | 50090-2081 | TABLET, FILM COATED | ORAL | METFORMIN HYDROCHLORIDE 500 mg/1 | A-S Medication Solutions | ANDA |
Glumetza metformin hydrochloride | 68012-002 | TABLET, FILM COATED, EXTENDED RELEASE | ORAL | METFORMIN HYDROCHLORIDE 500 mg/1 | Santarus, Inc. | NDA |
METFORMIN HYDROCHLORIDE | 71610-447 | TABLET, EXTENDED RELEASE | ORAL | METFORMIN HYDROCHLORIDE 500 mg/1 | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
Metformin HCl | 72789-189 | TABLET | ORAL | METFORMIN HYDROCHLORIDE 1000 mg/1 | PD-Rx Pharmaceuticals, Inc. | ANDA |
Metformin Hydrochloride | 42385-949 | TABLET, FILM COATED | ORAL | METFORMIN HYDROCHLORIDE 1000 mg/1 | Laurus Labs Limited | ANDA |
Glumetza metformin hydrochloride | 68012-003 | TABLET, FILM COATED, EXTENDED RELEASE | ORAL | METFORMIN HYDROCHLORIDE 1000 mg/1 | Santarus, Inc. | NDA |
Metformin Hydrochloride | 70518-3084 | TABLET | ORAL | METFORMIN HYDROCHLORIDE 850 mg/1 | REMEDYREPACK INC. | ANDA |
Metformin Hydrochloride | 71610-740 | TABLET, EXTENDED RELEASE | ORAL | METFORMIN HYDROCHLORIDE 750 mg/1 | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
METFORMIN HYDROCHLORIDE | 42806-633 | TABLET, EXTENDED RELEASE | ORAL | METFORMIN HYDROCHLORIDE 750 mg/1 | Epic Pharma, LLC | ANDA |
Metformin Hydrochloride Metformin Hydrochloride | 62147-0197 | GRANULE | — | METFORMIN HYDROCHLORIDE 25 kg/25kg | USV Private Limited | BULK INGREDIENT |
Glyburide and Metformin Hydrochloride | 65862-080 | TABLET, FILM COATED | ORAL | GLYBURIDE 1.25 mg/1；METFORMIN HYDROCHLORIDE 250 mg/1 | Aurobindo Pharma Limited | ANDA |
ertugliflozin and metformin hydrochloride ertugliflozin and metformin hydrochloride | 53922-0115 | TABLET, FILM COATED | — | ERTUGLIFLOZIN PIDOLATE 2.5 mg/1；METFORMIN HYDROCHLORIDE 500 mg/1 | MSD International GmbH (Puerto Rico Branch) LLC | DRUG FOR FURTHER PROCESSING |
Metformin Hydrochloride | 50090-5396 | TABLET, EXTENDED RELEASE | ORAL | METFORMIN HYDROCHLORIDE 500 mg/1 | A-S Medication Solutions | ANDA |
Metformin HCl | 68071-3541 | TABLET | ORAL | METFORMIN HYDROCHLORIDE 500 mg/1 | NuCare Pharmaceuticals,Inc. | ANDA |
ZITUVIMET XR sitagliptin and metformin hydrochloride | 70771-1879 | TABLET, FILM COATED, EXTENDED RELEASE | ORAL | SITAGLIPTIN 50 mg/1；METFORMIN HYDROCHLORIDE 500 mg/1 | Zydus Lifesciences Limited | NDA |
ertugliflozin and metformin hydrochloride ertugliflozin and metformin hydrochloride | 53922-0116 | TABLET, FILM COATED | — | ERTUGLIFLOZIN PIDOLATE 2.5 mg/1；METFORMIN HYDROCHLORIDE 1000 mg/1 | MSD International GmbH (Puerto Rico Branch) LLC | DRUG FOR FURTHER PROCESSING |
Metformin Hydrochloride | 50090-5397 | TABLET, EXTENDED RELEASE | ORAL | METFORMIN HYDROCHLORIDE 500 mg/1 | A-S Medication Solutions | ANDA |
Glyburide and Metformin Hydrochloride | 65862-081 | TABLET, FILM COATED | ORAL | GLYBURIDE 2.5 mg/1；METFORMIN HYDROCHLORIDE 500 mg/1 | Aurobindo Pharma Limited | ANDA |
Metformin hydrochloride | 68071-1419 | TABLET, EXTENDED RELEASE | ORAL | METFORMIN HYDROCHLORIDE 500 mg/1 | NuCare Pharmaceuticals, Inc. | ANDA |
ZITUVIMET XR sitagliptin and metformin hydrochloride | 70771-1880 | TABLET, FILM COATED, EXTENDED RELEASE | ORAL | SITAGLIPTIN 50 mg/1；METFORMIN HYDROCHLORIDE 1000 mg/1 | Zydus Lifesciences Limited | NDA |
ertugliflozin and metformin hydrochloride ertugliflozin and metformin hydrochloride | 53922-0117 | TABLET, FILM COATED | — | ERTUGLIFLOZIN PIDOLATE 7.5 mg/1；METFORMIN HYDROCHLORIDE 500 mg/1 | MSD International GmbH (Puerto Rico Branch) LLC | DRUG FOR FURTHER PROCESSING |
Metformin Hydrochloride | 50090-6753 | TABLET | ORAL | METFORMIN HYDROCHLORIDE 850 mg/1 | A-S Medication Solutions | ANDA |
Glyburide and Metformin Hydrochloride | 65862-082 | TABLET, FILM COATED | ORAL | GLYBURIDE 5 mg/1；METFORMIN HYDROCHLORIDE 500 mg/1 | Aurobindo Pharma Limited | ANDA |
ZITUVIMET XR sitagliptin and metformin hydrochloride | 70771-1881 | TABLET, FILM COATED, EXTENDED RELEASE | ORAL | SITAGLIPTIN 100 mg/1；METFORMIN HYDROCHLORIDE 1000 mg/1 | Zydus Lifesciences Limited | NDA |
Metformin HCl | 71205-548 | TABLET | ORAL | METFORMIN HYDROCHLORIDE 1000 mg/1 | Proficient Rx LP | ANDA |
Metformin Hydrochloride | 50090-6754 | TABLET | ORAL | METFORMIN HYDROCHLORIDE 850 mg/1 | A-S Medication Solutions | ANDA |
Metformin Hydrochloride | 68180-336 | TABLET, EXTENDED RELEASE | ORAL | METFORMIN HYDROCHLORIDE 500 mg/1 | Lupin Pharmaceuticals, Inc. | ANDA |
ertugliflozin and metformin hydrochloride ertugliflozin and metformin hydrochloride | 53922-0118 | TABLET, FILM COATED | — | ERTUGLIFLOZIN PIDOLATE 7.5 mg/1；METFORMIN HYDROCHLORIDE 1000 mg/1 | MSD International GmbH (Puerto Rico Branch) LLC | DRUG FOR FURTHER PROCESSING |
pioglitazone hydrochloride and metformin hydrochloride pioglitazone hydrochloride and metformin hydrochloride | 11532-0021 | TABLET | — | PIOGLITAZONE HYDROCHLORIDE 15 mg/1；METFORMIN HYDROCHLORIDE 500 mg/1 | Takeda Pharmaceutical Company LTD | DRUG FOR FURTHER PROCESSING |
Metformin Hydrochloride | 68180-337 | TABLET, EXTENDED RELEASE | ORAL | METFORMIN HYDROCHLORIDE 1000 mg/1 | Lupin Pharmaceuticals, Inc. | ANDA |
Glipizide and Metformin Hydrochloride | 70518-0373 | TABLET, FILM COATED | ORAL | GLIPIZIDE 5 mg/1；METFORMIN HYDROCHLORIDE 500 mg/1 | REMEDYREPACK INC. | ANDA |
pioglitazone hydrochloride and metformin hydrochloride pioglitazone hydrochloride and metformin hydrochloride | 11532-0022 | TABLET | — | PIOGLITAZONE HYDROCHLORIDE 15 mg/1；METFORMIN HYDROCHLORIDE 850 mg/1 | Takeda Pharmaceutical Company LTD | DRUG FOR FURTHER PROCESSING |
METFORMIN HYDROCHLORIDE | 68180-338 | TABLET, EXTENDED RELEASE | ORAL | METFORMIN HYDROCHLORIDE 500 mg/1 | Lupin Pharmaceuticals, Inc. | ANDA |
alogliptin and metformin hydrochloride alogliptin and metformin hydrochloride | 11532-1251 | TABLET, FILM COATED | — | ALOGLIPTIN BENZOATE 12.5 mg/1；METFORMIN HYDROCHLORIDE 1000 mg/1 | Takeda Pharmaceuticals Co LTD | DRUG FOR FURTHER PROCESSING |
METFORMIN HYDROCHLORIDE | 68180-339 | TABLET, EXTENDED RELEASE | ORAL | METFORMIN HYDROCHLORIDE 1000 mg/1 | Lupin Pharmaceuticals, Inc. | ANDA |
Metformin Hydrochloride | 87441-054 | TABLET | ORAL | METFORMIN HYDROCHLORIDE 1000 mg/1 | Unit Dose Solutions, Inc. | ANDA |
METFORMIN HYDROCHLORIDE metformin hydrochloride | 67877-159 | TABLET, EXTENDED RELEASE | ORAL | METFORMIN HYDROCHLORIDE 500 mg/1 | Ascend Laboratories, LLC | ANDA |
Sitagliptin and Metformin Hydrochloride sitagliptin and metformin hydrochloride | 70771-1886 | TABLET, FILM COATED, EXTENDED RELEASE | ORAL | SITAGLIPTIN 50 mg/1；METFORMIN HYDROCHLORIDE 1000 mg/1 | Zydus Lifesciences Limited | NDA AUTHORIZED GENERIC |
Sitagliptin and Metformin hydrochloride sitagliptin and metformin hydrochloride | 10370-318 | TABLET, FILM COATED, EXTENDED RELEASE | ORAL | SITAGLIPTIN PHOSPHATE 50 mg/1；METFORMIN HYDROCHLORIDE 1000 mg/1 | Par Health USA, LLC | ANDA |
SEGLUROMET ertugliflozin and metformin hydrochloride | 0006-5369 | TABLET, FILM COATED | ORAL | ERTUGLIFLOZIN PIDOLATE 2.5 mg/1；METFORMIN HYDROCHLORIDE 500 mg/1 | Merck Sharp & Dohme LLC | NDA |
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。