NDC 50458-578
Xarelto
Rivaroxaban
Xarelto is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Janssen Pharmaceuticals, Inc.. The primary component is Rivaroxaban.
| Product ID | 50458-578_271c2898-67e5-11e9-974e-d1c20099106d |
| NDC | 50458-578 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Xarelto |
| Generic Name | Rivaroxaban |
| Dosage Form | Tablet, Film Coated |
| Route of Administration | ORAL |
| Marketing Start Date | 2011-11-04 |
| Marketing Category | NDA / NDA |
| Application Number | NDA202439 |
| Labeler Name | Janssen Pharmaceuticals, Inc. |
| Substance Name | RIVAROXABAN |
| Active Ingredient Strength | 15 mg/1 |
| Pharm Classes | Factor Xa Inhibitors [MoA],Factor Xa Inhibitor [EPC] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2020-12-31 |
Packaging
NDC 50458-578-07
7 TABLET, FILM COATED in 1 BOTTLE (50458-578-07)
| Marketing Start Date | 2016-09-20 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 50458-578-07 [50458057807]
Xarelto TABLET, FILM COATED
| Marketing Category | NDA |
| Application Number | NDA202439 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2016-09-20 |
NDC 50458-578-30 [50458057830]
Xarelto TABLET, FILM COATED
| Marketing Category | NDA |
| Application Number | NDA202439 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2011-11-04 |
NDC 50458-578-90 [50458057890]
Xarelto TABLET, FILM COATED
| Marketing Category | NDA |
| Application Number | NDA202439 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2011-11-04 |
NDC 50458-578-14 [50458057814]
Xarelto TABLET, FILM COATED
| Marketing Category | NDA |
| Application Number | NDA202439 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2011-11-04 |
NDC 50458-578-01 [50458057801]
Xarelto TABLET, FILM COATED
| Marketing Category | NDA |
| Application Number | NDA202439 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2019-07-25 |
NDC 50458-578-10 [50458057810]
Xarelto TABLET, FILM COATED
| Marketing Category | NDA |
| Application Number | NDA202439 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2011-11-04 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| RIVAROXABAN | 15 mg/1 |
OpenFDA Data
| SPL SET ID: | 10db92f9-2300-4a80-836b-673e1ae91610 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
Pharmacological Class
- Factor Xa Inhibitors [MoA]
- Factor Xa Inhibitor [EPC]
Medicade Reported Pricing
50458057890 XARELTO 15 MG TABLET
Pricing Unit: EA | Drug Type:
50458057830 XARELTO 15 MG TABLET
Pricing Unit: EA | Drug Type:
50458057810 XARELTO 15 MG TABLET
Pricing Unit: EA | Drug Type:
NDC Crossover Matching brand name "Xarelto" or generic name "Rivaroxaban"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 50090-3625 | Xarelto | rivaroxaban |
| 50090-3639 | Xarelto | rivaroxaban |
| 50090-4468 | Xarelto | rivaroxaban |
| 50090-4469 | Xarelto | rivaroxaban |
| 50458-575 | Xarelto | rivaroxaban |
| 50458-577 | XARELTO | rivaroxaban |
| 50458-578 | Xarelto | rivaroxaban |
| 50458-579 | Xarelto | rivaroxaban |
| 50458-580 | Xarelto | Xarelto |
| 50458-584 | XARELTO | XARELTO |
| 55154-1423 | Xarelto | Xarelto |
| 55154-1424 | Xarelto | Xarelto |
| 55154-1422 | Xarelto | Xarelto |
Trademark Results [Xarelto]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 XARELTO 78152154 2804753 Live/Registered |
Bayer Aktiengesellschaft 2002-08-08 |
 XARELTO 77752463 4105934 Live/Registered |
Bayer Aktiengesellschaft 2009-06-04 |
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