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 741 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 |
|---|---|---|---|---|---|---|
Metformin Hydrochloride Metformin Hydrochloride | 62207-012 | POWDER | — | METFORMIN HYDROCHLORIDE 50 kg/50kg | Granules India Ltd | BULK INGREDIENT |
Metformin Hydrochloride | 60687-162 | TABLET, FILM COATED | ORAL | METFORMIN HYDROCHLORIDE 1000 mg/1 | American Health Packaging | ANDA |
Metformin hydrochloride ER Metformin hydrochloride | 42291-824 | TABLET, EXTENDED RELEASE | ORAL | METFORMIN HYDROCHLORIDE 750 mg/1 | AvKARE | ANDA |
Saxagliptin and Metformin Hydrochloride | 43598-619 | TABLET, FILM COATED, EXTENDED RELEASE | ORAL | SAXAGLIPTIN 5 mg/1；METFORMIN HYDROCHLORIDE 1000 mg/1 | Dr.Reddys Laboratories Inc | ANDA |
METFORMIN HYDROCHLORIDE | 50090-8041 | TABLET, FILM COATED | ORAL | METFORMIN HYDROCHLORIDE 500 mg/1 | A-S Medication Solutions | ANDA |
Metformin Hydrochloride | 68788-8903 | TABLET, EXTENDED RELEASE | ORAL | METFORMIN HYDROCHLORIDE 500 mg/1 | Preferred Pharmaceuticals Inc. | ANDA |
Metformin hydrochloride | 42291-825 | TABLET, EXTENDED RELEASE | ORAL | METFORMIN HYDROCHLORIDE 500 mg/1 | AvKARE | ANDA |
Saxagliptin and Metformin Hydrochloride | 43598-620 | TABLET, FILM COATED, EXTENDED RELEASE | ORAL | SAXAGLIPTIN 5 mg/1；METFORMIN HYDROCHLORIDE 500 mg/1 | Dr.Reddys Laboratories Inc | ANDA |
METFORMIN HYDROCHLORIDE | 50090-8043 | TABLET, FILM COATED | ORAL | METFORMIN HYDROCHLORIDE 500 mg/1 | A-S Medication Solutions | ANDA |
Pioglitazole and metformin hydrochloride | 72162-2497 | TABLET | ORAL | PIOGLITAZONE HYDROCHLORIDE 15 mg/1；METFORMIN HYDROCHLORIDE 500 mg/1 | Bryant Ranch Prepack | ANDA |
Metformin Hydrochloride | 72789-548 | TABLET, EXTENDED RELEASE | ORAL | METFORMIN HYDROCHLORIDE 750 mg/1 | PD-Rx Pharmaceuticals, Inc. | ANDA |
Metformin Hydrochloride Metformin Hydrochloride | 62207-012 | POWDER | — | METFORMIN HYDROCHLORIDE 50 kg/50kg | Granules India Limited | BULK INGREDIENT |
alogliptin and metformin hydrochloride | 45802-211 | TABLET, FILM COATED | ORAL | ALOGLIPTIN BENZOATE 12.5 mg/1；METFORMIN HYDROCHLORIDE 1000 mg/1 | Padagis Israel Pharmaceuticals Ltd | NDA AUTHORIZED GENERIC |
Pioglitazole and metformin hydrochloride | 72162-2498 | TABLET | ORAL | PIOGLITAZONE HYDROCHLORIDE 15 mg/1；METFORMIN HYDROCHLORIDE 850 mg/1 | Bryant Ranch Prepack | ANDA |
Metformin hydrochloride | 68645-584 | TABLET | ORAL | METFORMIN HYDROCHLORIDE 1000 mg/1 | Legacy Pharmaceutical Packaging, LLC | ANDA |
Metformin Hydrochloride | 68788-8600 | TABLET, FILM COATED | ORAL | METFORMIN HYDROCHLORIDE 1000 mg/1 | Preferred Pharmaceuticals Inc. | ANDA |
METFORMIN HYDROCHLORIDE Metformin Hydrochloride | 70010-496 | TABLET, EXTENDED RELEASE | ORAL | METFORMIN HYDROCHLORIDE 500 mg/1 | Granules Pharmaceuticals Inc. | ANDA |
Metformin Hydrochloride | 72578-035 | TABLET, EXTENDED RELEASE | ORAL | METFORMIN HYDROCHLORIDE 500 mg/1 | Viona Pharmaceuticals Inc | ANDA |
Metformin Hydrochloride and Sitagliptin Phosphate Metformin Hydrochloride and Sitagliptin Phosphate | 43798-003 | TABLET, FILM COATED | — | METFORMIN HYDROCHLORIDE 1000 mg/1；SITAGLIPTIN PHOSPHATE 50 mg/1 | Aesica Queenborough Limited | DRUG FOR FURTHER PROCESSING |
Metformin Hydrochloride Metformin Hydrochloride | 62147-0197 | GRANULE | — | METFORMIN HYDROCHLORIDE 25 kg/25kg | USV Private Limited | BULK INGREDIENT |
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 | 50090-7454 | TABLET, COATED | ORAL | METFORMIN HYDROCHLORIDE 1000 mg/1 | A-S Medication Solutions | ANDA |
glyburide and metformin hydrochloride | 65841-824 | TABLET | ORAL | GLYBURIDE 1.25 mg/1；METFORMIN HYDROCHLORIDE 250 mg/1 | Zydus Lifesciences Limited | ANDA |
Metformin hydrochloride | 68645-582 | TABLET | ORAL | METFORMIN HYDROCHLORIDE 500 mg/1 | Legacy Pharmaceutical Packaging, LLC | ANDA |
Metformin Metformin ER 500 mg | 70010-491 | TABLET, EXTENDED RELEASE | ORAL | METFORMIN HYDROCHLORIDE 500 mg/1 | Granules Pharmaceuticals Inc. | ANDA |
METFORMIN HYDROCHLORIDE | 82804-309 | TABLET, FILM COATED | ORAL | METFORMIN HYDROCHLORIDE 500 mg/1 | Proficient Rx LP | 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 |
Metformin Hydrochloride | 50090-7455 | TABLET, COATED | ORAL | METFORMIN HYDROCHLORIDE 1000 mg/1 | A-S Medication Solutions | ANDA |
XIGDUO XR dapagliflozin and metformin hydrochloride | 0310-6260 | TABLET, FILM COATED, EXTENDED RELEASE | ORAL | DAPAGLIFLOZIN PROPANEDIOL 5 mg/1；METFORMIN HYDROCHLORIDE 1000 mg/1 | AstraZeneca Pharmaceuticals LP | NDA |
glyburide and metformin hydrochloride | 65841-825 | TABLET | ORAL | GLYBURIDE 2.5 mg/1；METFORMIN HYDROCHLORIDE 500 mg/1 | Zydus Lifesciences Limited | ANDA |
Metformin hydrochloride | 68645-583 | TABLET | ORAL | METFORMIN HYDROCHLORIDE 850 mg/1 | Legacy Pharmaceutical Packaging, LLC | ANDA |
Metformin Metformin ER 750 mg | 70010-492 | TABLET, EXTENDED RELEASE | ORAL | METFORMIN HYDROCHLORIDE 750 mg/1 | Granules Pharmaceuticals Inc. | ANDA |
Glyburide and Metformin Hydrochloride | 71335-0967 | TABLET, FILM COATED | ORAL | GLYBURIDE 5 mg/1；METFORMIN HYDROCHLORIDE 500 mg/1 | Bryant Ranch Prepack | ANDA |
Metformin HCl | 80425-0435 | TABLET | ORAL | METFORMIN HYDROCHLORIDE 1000 mg/1 | Advanced Rx of Tennessee, LLC | ANDA |
glyburide and metformin hydrochloride | 65841-826 | TABLET | ORAL | GLYBURIDE 5 mg/1；METFORMIN HYDROCHLORIDE 500 mg/1 | Zydus Lifesciences Limited | ANDA |
METFORMIN HYDROCHLORIDE | 68788-8866 | TABLET, EXTENDED RELEASE | ORAL | METFORMIN HYDROCHLORIDE 500 mg/1 | Preferred Pharmaceuticals Inc. | ANDA |
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 | 63629-9147 | TABLET, EXTENDED RELEASE | ORAL | METFORMIN HYDROCHLORIDE 750 mg/1 | Bryant Ranch Prepack | ANDA |
METFORMIN HYDROCHLORIDE Metformin Hydrochloride | 70010-497 | TABLET, EXTENDED RELEASE | ORAL | METFORMIN HYDROCHLORIDE 1000 mg/1 | Granules Pharmaceuticals Inc. | ANDA |
Metformin Hydrochloride | 72578-036 | TABLET, EXTENDED RELEASE | ORAL | METFORMIN HYDROCHLORIDE 750 mg/1 | Viona Pharmaceuticals Inc | ANDA |
METFORMIN HYDROCHLORIDE EXTENDED RELEASE Metformin Hydrochloride | 51655-555 | TABLET, EXTENDED RELEASE | ORAL | METFORMIN HYDROCHLORIDE 500 mg/1 | Northwind Health Company, LLC | ANDA |
Metformin Hydrochloride | 50090-6839 | TABLET, EXTENDED RELEASE | ORAL | METFORMIN HYDROCHLORIDE 750 mg/1 | A-S Medication Solutions | ANDA |
Metformin Hydrochloride | 51655-556 | TABLET | ORAL | METFORMIN HYDROCHLORIDE 500 mg/1 | Northwind Health Company, LLC | ANDA |
Metformin Hydrochloride | 51655-077 | TABLET, EXTENDED RELEASE | ORAL | METFORMIN HYDROCHLORIDE 750 mg/1 | Northwind Health Company, LLC | ANDA |
Metformin Metformin ER 500 mg | 68645-595 | TABLET, EXTENDED RELEASE | ORAL | METFORMIN HYDROCHLORIDE 500 mg/1 | Legacy Pharmaceutical Packaging, LLC | ANDA |
METFORMIN HYDROCHLORIDE metformin hydrochloride | 68788-8603 | TABLET | ORAL | METFORMIN HYDROCHLORIDE 850 mg/1 | Preferred Pharmaceuticals Inc. | ANDA |
Glyburide and Metformin Hydrochloride | 71335-0360 | TABLET, FILM COATED | ORAL | GLYBURIDE 5 mg/1；METFORMIN HYDROCHLORIDE 500 mg/1 | Bryant Ranch Prepack | ANDA |
Metformin HCL | 72189-658 | TABLET, FILM COATED | ORAL | METFORMIN HYDROCHLORIDE 500 mg/1 | Direct_Rx | ANDA |
METFORMIN HYDROCHLORIDE | 67877-932 | TABLET, FILM COATED | ORAL | METFORMIN HYDROCHLORIDE 1000 mg/1 | Ascend Laboratories, LLC | 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 |
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。