Bivalirudin is a Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Hainan Shuangcheng Pharmaceuticals Co., Ltd.. The primary component is Bivalirudin.
| Product ID | 52958-034_0a40c711-2cfd-4c29-9ee0-84087f633fae |
| NDC | 52958-034 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Bivalirudin |
| Generic Name | Bivalirudin |
| Dosage Form | Injection, Powder, Lyophilized, For Solution |
| Route of Administration | INTRAVENOUS |
| Marketing Start Date | 2019-10-28 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA210031 |
| Labeler Name | Hainan Shuangcheng Pharmaceuticals Co., Ltd. |
| Substance Name | BIVALIRUDIN |
| Active Ingredient Strength | 250 mg/1 |
| Pharm Classes | Anti-coagulant [EPC],Direct Thrombin Inhibitor [EPC],Thrombin Inhibitors [MoA] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2020-12-31 |
| Marketing Start Date | 2020-10-23 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA210031 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2019-10-28 |
| Ingredient | Strength |
|---|---|
| BIVALIRUDIN | 250 mg/1 |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0409-8300 | Bivalirudin | BIVALIRUDIN |
| 0781-3158 | bivalirudin | bivalirudin |
| 0781-9158 | bivalirudin | bivalirudin |
| 16729-275 | Bivalirudin | Bivalirudin |
| 25021-405 | bivalirudin | bivalirudin |
| 52958-034 | Bivalirudin | Bivalirudin |
| 55111-652 | Bivalirudin | Bivalirudin |
| 55150-210 | BIVALIRUDIN | BIVALIRUDIN |
| 60505-6101 | Bivalirudin | bivalirudin |
| 63323-562 | Bivalirudin | Bivalirudin |
| 67457-256 | Bivalirudin | bivalirudin |
| 69097-601 | bivalirudin | bivalirudin |
| 70511-141 | bivalirudin | bivalirudin |
| 70860-402 | Bivalirudin | Bivalirudin |
| 72572-035 | bivalirudin | bivalirudin |
| 71288-427 | BIVALIRUDIN | BIVALIRUDIN |
| 0781-3447 | Angiomax | bivalirudin |
| 65293-001 | Angiomax | bivalirudin |