Product NDC: | 50458-578 |
Proprietary Name: | Xarelto |
Non Proprietary Name: | rivaroxaban |
Active Ingredient(s): | 15 mg/1 & nbsp; rivaroxaban |
Administration Route(s): | ORAL |
Dosage Form(s): | TABLET, FILM COATED |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 50458-578 |
Labeler Name: | Janssen Pharmaceuticals, Inc. |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | NDA202439 |
Marketing Category: | NDA |
Start Marketing Date: | 20111104 |
Package NDC: | 50458-578-10 |
Package Description: | 10 BLISTER PACK in 1 CARTON (50458-578-10) > 10 TABLET, FILM COATED in 1 BLISTER PACK |
NDC Code | 50458-578-10 |
Proprietary Name | Xarelto |
Package Description | 10 BLISTER PACK in 1 CARTON (50458-578-10) > 10 TABLET, FILM COATED in 1 BLISTER PACK |
Product NDC | 50458-578 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | rivaroxaban |
Dosage Form Name | TABLET, FILM COATED |
Route Name | ORAL |
Start Marketing Date | 20111104 |
Marketing Category Name | NDA |
Labeler Name | Janssen Pharmaceuticals, Inc. |
Substance Name | RIVAROXABAN |
Strength Number | 15 |
Strength Unit | mg/1 |
Pharmaceutical Classes | Factor Xa Inhibitors [MoA],Factor Xa Inhibitor [EPC] |