| Product NDC: | 55566-2100 | 
| Proprietary Name: | Lysteda | 
| Non Proprietary Name: | Tranexamic Acid | 
| Active Ingredient(s): | 650 mg/1 & nbsp; Tranexamic Acid | 
| Administration Route(s): | ORAL | 
| Dosage Form(s): | TABLET | 
| Coding System: | National Drug Codes(NDC) | 
| Product NDC: | 55566-2100 | 
| Labeler Name: | Ferring Pharmaceuticals Inc. | 
| Product Type: | HUMAN PRESCRIPTION DRUG | 
| FDA Application Number: | NDA022430 | 
| Marketing Category: | NDA | 
| Start Marketing Date: | 20100517 | 
| Package NDC: | 55566-2100-1 | 
| Package Description: | 1 BOTTLE in 1 CARTON (55566-2100-1) > 100 TABLET in 1 BOTTLE | 
| NDC Code | 55566-2100-1 | 
| Proprietary Name | Lysteda | 
| Package Description | 1 BOTTLE in 1 CARTON (55566-2100-1) > 100 TABLET in 1 BOTTLE | 
| Product NDC | 55566-2100 | 
| Product Type Name | HUMAN PRESCRIPTION DRUG | 
| Non Proprietary Name | Tranexamic Acid | 
| Dosage Form Name | TABLET | 
| Route Name | ORAL | 
| Start Marketing Date | 20100517 | 
| Marketing Category Name | NDA | 
| Labeler Name | Ferring Pharmaceuticals Inc. | 
| Substance Name | TRANEXAMIC ACID | 
| Strength Number | 650 | 
| Strength Unit | mg/1 | 
| Pharmaceutical Classes | Antifibrinolytic Agent [EPC],Decreased Fibrinolysis [PE] |