FDA.reportPublic FDA data

XARELTO

Product NDC
50458-577
11-digit product format
504580577
Labeler code
50458
Product ID
50458-577_452610f0-5abb-448d-a1fc-9dd9be02bb66
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
rivaroxaban
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Janssen Pharmaceuticals, Inc.
Application
NDA022406
Marketing category
NDA
Marketing start
2018-10-09
Substance
RIVAROXABAN
Active strength
2.5 mg/1
Pharmacologic classes
Factor Xa Inhibitor [EPC], Factor Xa Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
XARELTO
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
RIVAROXABAN2.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9NDF7JZ4M3
Rxcui1114198, 1114202, 1232082, 1232084, 1232086, 1232088, 1549682, 1549683, 2059015, 2059017, 2588062, 2588066

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6cd5c957-f63d-4ae5-a5e5-4e6830870998Product name320251209
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50458-577-01XARELTO10 in 1 BLISTER PACKTABLET, FILM COATED1064
50458-577-10XARELTO10 in 1 BOX, UNIT-DOSETABLET, FILM COATED1064
50458-577-14XARELTO14 in 1 BOTTLETABLET, FILM COATED1464
50458-577-18XARELTO180 in 1 BOTTLETABLET, FILM COATED18064
50458-577-60XARELTO60 in 1 BOTTLETABLET, FILM COATED6064

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50458-577-01EA - Each50458-5774441aa0e-0318-4e84-932e-0d043e49981812018-12-13
50458-577-10EA - Each50458-5771b68c21e-da18-4ee4-bdd2-f7959866cb3312018-11-06
50458-577-14EA - Each50458-5771c9515e9-13ba-4f08-9582-135b5425b6bb12022-03-09
50458-577-18EA - Each50458-57797e3c3ad-64bd-4e2d-bb78-7d68267f2f2712018-11-06
50458-577-60EA - Each50458-577426d617a-af8e-4499-9d8f-1309d1dc964812018-11-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
rivaroxabanACTIVE INGREDIENT9NDF7JZ4M3XARELTO (RIVAROXABAN) TABLET, FILM COATED XARELTO (RIVAROXABAN) KIT [JANSSEN PHARMACEUTICALS, INC.]17
rivaroxabanACTIVE MOIETY9NDF7JZ4M3XARELTO (RIVAROXABAN) TABLET, FILM COATED XARELTO (RIVAROXABAN) KIT [JANSSEN PHARMACEUTICALS, INC.]17
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UXARELTO (RIVAROXABAN) TABLET, FILM COATED XARELTO (RIVAROXABAN) KIT [JANSSEN PHARMACEUTICALS, INC.]17
croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48XARELTO (RIVAROXABAN) TABLET, FILM COATED XARELTO (RIVAROXABAN) KIT [JANSSEN PHARMACEUTICALS, INC.]17
ferric oxide redINACTIVE INGREDIENT1K09F3G675XARELTO (RIVAROXABAN) TABLET, FILM COATED XARELTO (RIVAROXABAN) KIT [JANSSEN PHARMACEUTICALS, INC.]17
hypromellosesINACTIVE INGREDIENT3NXW29V3WOXARELTO (RIVAROXABAN) TABLET, FILM COATED XARELTO (RIVAROXABAN) KIT [JANSSEN PHARMACEUTICALS, INC.]17
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XXARELTO (RIVAROXABAN) TABLET, FILM COATED XARELTO (RIVAROXABAN) KIT [JANSSEN PHARMACEUTICALS, INC.]17
magnesium stearateINACTIVE INGREDIENT70097M6I30XARELTO (RIVAROXABAN) TABLET, FILM COATED XARELTO (RIVAROXABAN) KIT [JANSSEN PHARMACEUTICALS, INC.]17
polyethylene glycol 3350INACTIVE INGREDIENTG2M7P15E5PXARELTO (RIVAROXABAN) TABLET, FILM COATED XARELTO (RIVAROXABAN) KIT [JANSSEN PHARMACEUTICALS, INC.]17
polyvinyl alcoholINACTIVE INGREDIENT532B59J990XARELTO (RIVAROXABAN) TABLET, FILM COATED XARELTO (RIVAROXABAN) KIT [JANSSEN PHARMACEUTICALS, INC.]17
sodium lauryl sulfateINACTIVE INGREDIENT368GB5141JXARELTO (RIVAROXABAN) TABLET, FILM COATED XARELTO (RIVAROXABAN) KIT [JANSSEN PHARMACEUTICALS, INC.]17
talcINACTIVE INGREDIENT7SEV7J4R1UXARELTO (RIVAROXABAN) TABLET, FILM COATED XARELTO (RIVAROXABAN) KIT [JANSSEN PHARMACEUTICALS, INC.]17
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPXARELTO (RIVAROXABAN) TABLET, FILM COATED XARELTO (RIVAROXABAN) KIT [JANSSEN PHARMACEUTICALS, INC.]17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50458-577XARELTO (RIVAROXABAN) TABLET, FILM COATED XARELTO (RIVAROXABAN) TABLET, FILM COATED XARELTO (RIVAROXABAN) KIT XARELTO (RIVAROXABAN) GRANULE, FOR SUSPENSION [JANSSEN PHARMACEUTICALS, INC.]59Current NDC, Legacy NDC, 5 package rows20250409_10db92f9-2300-4a80-836b-673e1ae91610.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1549683{42 (rivaroxaban 15 MG Oral Tablet [Xarelto]) / 9 (rivaroxaban 20 MG Oral Tablet [Xarelto]) } Pack [Xarelto Kit]BPCK10db92f9-2300-4a80-836b-673e1ae9161064
1549682{42 (rivaroxaban 15 MG Oral Tablet) / 9 (rivaroxaban 20 MG Oral Tablet) } PackGPCK10db92f9-2300-4a80-836b-673e1ae9161064
2588062rivaroxaban 1 MG/mL Oral SuspensionPSN10db92f9-2300-4a80-836b-673e1ae9161064
1114198rivaroxaban 10 MG Oral TabletPSN10db92f9-2300-4a80-836b-673e1ae9161064
1232082rivaroxaban 15 MG Oral TabletPSN10db92f9-2300-4a80-836b-673e1ae9161064
2059015rivaroxaban 2.5 MG Oral TabletPSN10db92f9-2300-4a80-836b-673e1ae9161064
1232086rivaroxaban 20 MG Oral TabletPSN10db92f9-2300-4a80-836b-673e1ae9161064
1549682rivaroxaban 30-Day Starter Pack (42-15 MG Oral Tablets & 9-20 MG Oral Tablets)PSN10db92f9-2300-4a80-836b-673e1ae9161064
2588066Xarelto 1 MG/mL Oral SuspensionPSN10db92f9-2300-4a80-836b-673e1ae9161064
1114202Xarelto 10 MG Oral TabletPSN10db92f9-2300-4a80-836b-673e1ae9161064
1232084Xarelto 15 MG Oral TabletPSN10db92f9-2300-4a80-836b-673e1ae9161064
2059017Xarelto 2.5 MG Oral TabletPSN10db92f9-2300-4a80-836b-673e1ae9161064
1232088Xarelto 20 MG Oral TabletPSN10db92f9-2300-4a80-836b-673e1ae9161064
1549683Xarelto Starter Pack, 30-DayPSN10db92f9-2300-4a80-836b-673e1ae9161064
2588066rivaroxaban 1 MG/ML Oral Suspension [Xarelto]SBD10db92f9-2300-4a80-836b-673e1ae9161064
1114202rivaroxaban 10 MG Oral Tablet [Xarelto]SBD10db92f9-2300-4a80-836b-673e1ae9161064
1232084rivaroxaban 15 MG Oral Tablet [Xarelto]SBD10db92f9-2300-4a80-836b-673e1ae9161064
2059017rivaroxaban 2.5 MG Oral Tablet [Xarelto]SBD10db92f9-2300-4a80-836b-673e1ae9161064
1232088rivaroxaban 20 MG Oral Tablet [Xarelto]SBD10db92f9-2300-4a80-836b-673e1ae9161064
2588062rivaroxaban 1 MG/ML Oral SuspensionSCD10db92f9-2300-4a80-836b-673e1ae9161064
1114198rivaroxaban 10 MG Oral TabletSCD10db92f9-2300-4a80-836b-673e1ae9161064
1232082rivaroxaban 15 MG Oral TabletSCD10db92f9-2300-4a80-836b-673e1ae9161064
2059015rivaroxaban 2.5 MG Oral TabletSCD10db92f9-2300-4a80-836b-673e1ae9161064
1232086rivaroxaban 20 MG Oral TabletSCD10db92f9-2300-4a80-836b-673e1ae9161064
1549682rivaroxaban 30-Day Starter Pack (42-15 MG Oral Tablets & 9-20 MG Oral Tablets)SY10db92f9-2300-4a80-836b-673e1ae9161064
2588066Xarelto 1 MG/ML Oral SuspensionSY10db92f9-2300-4a80-836b-673e1ae9161064
1114202Xarelto 10 MG Oral TabletSY10db92f9-2300-4a80-836b-673e1ae9161064
1232084Xarelto 15 MG Oral TabletSY10db92f9-2300-4a80-836b-673e1ae9161064
2059017Xarelto 2.5 MG Oral TabletSY10db92f9-2300-4a80-836b-673e1ae9161064
1232088Xarelto 20 MG Oral TabletSY10db92f9-2300-4a80-836b-673e1ae9161064
1549683Xarelto 30-Day Starter Pack KitSY10db92f9-2300-4a80-836b-673e1ae9161064

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50458-577-015045805770110 in 1 BLISTER PACKHistorical
50458-577-105045805771010 BLISTER PACK in 1 BOX, UNIT-DOSE (50458-577-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK (50458-577-01) 10 blister pack2018-10-090000-00-00NoNoCurrent
50458-577-145045805771414 TABLET, FILM COATED in 1 BOTTLE (50458-577-14) 2018-10-090000-00-00YesNoCurrent
50458-577-1850458057718180 TABLET, FILM COATED in 1 BOTTLE (50458-577-18) 2018-10-090000-00-00NoNoCurrent
50458-577-605045805776060 TABLET, FILM COATED in 1 BOTTLE (50458-577-60) 2018-10-090000-00-00NoNoCurrent