| Product NDC: | 63323-563 |
| Proprietary Name: | Tranexamic Acid |
| Non Proprietary Name: | Tranexamic Acid |
| Active Ingredient(s): | 100 mg/mL & nbsp; Tranexamic Acid |
| Administration Route(s): | INTRAVENOUS |
| Dosage Form(s): | INJECTION, SOLUTION |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 63323-563 |
| Labeler Name: | APP Pharmaceuticals, LLC |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | ANDA202373 |
| Marketing Category: | ANDA |
| Start Marketing Date: | 20120420 |
| Package NDC: | 63323-563-97 |
| Package Description: | 10 AMPULE in 1 BOX (63323-563-97) > 10 mL in 1 AMPULE |
| NDC Code | 63323-563-97 |
| Proprietary Name | Tranexamic Acid |
| Package Description | 10 AMPULE in 1 BOX (63323-563-97) > 10 mL in 1 AMPULE |
| Product NDC | 63323-563 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | Tranexamic Acid |
| Dosage Form Name | INJECTION, SOLUTION |
| Route Name | INTRAVENOUS |
| Start Marketing Date | 20120420 |
| Marketing Category Name | ANDA |
| Labeler Name | APP Pharmaceuticals, LLC |
| Substance Name | TRANEXAMIC ACID |
| Strength Number | 100 |
| Strength Unit | mg/mL |
| Pharmaceutical Classes | Antifibrinolytic Agent [EPC],Decreased Fibrinolysis [PE] |