Xarelto - 50458-578-90 - (rivaroxaban)

Alphabetical Index


Drug Information of Xarelto

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)

Labeler Information of Xarelto

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 Information of Xarelto

Package NDC: 50458-578-90
Package Description: 90 TABLET, FILM COATED in 1 BOTTLE (50458-578-90)

NDC Information of Xarelto

NDC Code 50458-578-90
Proprietary Name Xarelto
Package Description 90 TABLET, FILM COATED in 1 BOTTLE (50458-578-90)
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]

Complete Information of Xarelto


General Information