| Product NDC: | 50458-580 |
| Proprietary Name: | Xarelto |
| Non Proprietary Name: | rivaroxaban |
| Active Ingredient(s): | 10 mg/1 & nbsp; rivaroxaban |
| Administration Route(s): | ORAL |
| Dosage Form(s): | TABLET, FILM COATED |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 50458-580 |
| Labeler Name: | Janssen Pharmaceuticals, Inc. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA022406 |
| Marketing Category: | NDA |
| Start Marketing Date: | 20110701 |
| Package NDC: | 50458-580-10 |
| Package Description: | 10 BLISTER PACK in 1 CARTON (50458-580-10) > 10 TABLET, FILM COATED in 1 BLISTER PACK |
| NDC Code | 50458-580-10 |
| Proprietary Name | Xarelto |
| Package Description | 10 BLISTER PACK in 1 CARTON (50458-580-10) > 10 TABLET, FILM COATED in 1 BLISTER PACK |
| Product NDC | 50458-580 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | rivaroxaban |
| Dosage Form Name | TABLET, FILM COATED |
| Route Name | ORAL |
| Start Marketing Date | 20110701 |
| Marketing Category Name | NDA |
| Labeler Name | Janssen Pharmaceuticals, Inc. |
| Substance Name | RIVAROXABAN |
| Strength Number | 10 |
| Strength Unit | mg/1 |
| Pharmaceutical Classes | Factor Xa Inhibitors [MoA],Factor Xa Inhibitor [EPC] |