Xarelto - 50458-580-10 - (rivaroxaban)

Alphabetical Index


Drug Information of Xarelto

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)

Labeler Information of Xarelto

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 Information of Xarelto

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 Information of Xarelto

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]

Complete Information of Xarelto


General Information