Tranexamic Acid is a Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Caplin Steriles Limited. The primary component is Tranexamic Acid.
| Product ID | 65145-106_2a487e17-1a4f-4b46-800a-068443b2d7f3 |
| NDC | 65145-106 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Tranexamic Acid |
| Generic Name | Tranexamic Acid |
| Dosage Form | Injection |
| Route of Administration | INTRAVENOUS |
| Marketing Start Date | 2019-07-28 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA212360 |
| Labeler Name | Caplin Steriles Limited |
| Substance Name | TRANEXAMIC ACID |
| Active Ingredient Strength | 100 mg/mL |
| Pharm Classes | Antifibrinolytic Agent [EPC],Decreased Fibrinolysis [PE] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2020-12-31 |
| Marketing Start Date | 2021-09-08 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA212360 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2019-07-28 |
| Marketing Category | ANDA |
| Application Number | ANDA212360 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2019-07-28 |
| Ingredient | Strength |
|---|---|
| TRANEXAMIC ACID | 100 mg/mL |
| SPL SET ID: | 6326bdbf-fb2e-451a-a0a0-7d0b59ce5438 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI | |
| UPC Code |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0517-0960 | Tranexamic Acid | tranexamic acid |
| 0591-3720 | Tranexamic Acid | Tranexamic Acid |
| 14789-500 | Tranexamic acid | TRANEXAMIC ACID |
| 17478-017 | Tranexamic Acid | Tranexamic Acid |
| 17478-018 | Tranexamic Acid | Tranexamic Acid |
| 17478-217 | TRANEXAMIC ACID | Tranexamic Acid |
| 23155-166 | Tranexamic Acid | Tranexamic Acid |
| 23155-524 | Tranexamic Acid | Tranexamic Acid |
| 39822-1000 | Tranexamic Acid | Tranexamic Acid |
| 39822-1001 | Tranexamic Acid | Tranexamic Acid |
| 67850-041 | Tranexamic Acid | Tranexamic Acid |
| 68083-160 | Tranexamic acid | Tranexamic acid |
| 68084-929 | Tranexamic Acid | Tranexamic Acid |
| 68382-891 | Tranexamic Acid | Tranexamic Acid |
| 69543-376 | Tranexamic Acid | Tranexamic Acid |
| 69918-301 | Tranexamic Acid | Tranexamic Acid |
| 70121-1398 | Tranexamic Acid | Tranexamic Acid |
| 70771-1085 | Tranexamic Acid | Tranexamic Acid |
| 70860-400 | Tranexamic Acid | Tranexamic Acid |
| 42192-605 | Tranexamic Acid | Tranexamic Acid |
| 42571-189 | Tranexamic Acid | Tranexamic Acid |
| 42571-314 | TRANEXAMIC ACID | TRANEXAMIC ACID |
| 47781-601 | Tranexamic Acid | Tranexamic Acid |
| 55150-188 | Tranexamic Acid | Tranexamic Acid |
| 60505-3638 | Tranexamic Acid | Tranexamic Acid |
| 63323-563 | Tranexamic Acid | Tranexamic Acid |
| 66993-121 | Tranexamic Acid | Tranexamic Acid |
| 66993-090 | Tranexamic Acid | Tranexamic Acid |
| 67457-197 | Tranexamic Acid | Tranexamic Acid |
| 67850-042 | Tranexamic Acid | Tranexamic Acid |
| 65145-106 | Tranexamic Acid | Tranexamic Acid |
| 50090-4530 | Tranexamic Acid | Tranexamic Acid |
| 61990-0611 | tranexamic acid | tranexamic acid |
| 0013-1114 | Cyklokapron | tranexamic acid |