FDA.reportPublic FDA data

Xarelto

Product NDC
50090-4469
11-digit product format
500904469
Labeler code
50090
Product ID
50090-4469_4d42fd56-57bd-43a6-93c9-6454028dfef4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
rivaroxaban
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
NDA022406
Marketing category
NDA
Marketing start
2011-07-01
Substance
RIVAROXABAN
Active strength
10 mg/1
Pharmacologic classes
Factor Xa Inhibitor [EPC], Factor Xa Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Xarelto
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
RIVAROXABAN10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9NDF7JZ4M3
Rxcui1114198, 1114202

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6cd5c957-f63d-4ae5-a5e5-4e6830870998Product name320251209
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-4469-02024-05-22C16284748780-1f386c64a-403b-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use XARELTO safely and effectively. See full prescribing information for XARELTO. XARELTO ® (rivaroxaban) tablets, for oral use XARELTO ® (rivaroxaban) for oral suspension Initial U.S. Approval: 2011
50090-4469-02023-01-30C16284748780-1f386c64a-403b-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use XARELTO safely and effectively. See full prescribing information for XARELTO. XARELTO ® (rivaroxaban) tablets, for oral use XARELTO ® (rivaroxaban) for oral suspension Initial U.S. Approval: 2011

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4469-0Xarelto90 in 1 BOTTLETABLET, FILM COATED907

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-4469-0EA - Each50090-446902c8b04f-a5d7-4478-a53b-3a821a95513712022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4469XARELTO (RIVAROXABAN) TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]7Current NDC, Legacy NDC, 1 package rows20240524_65727928-9421-4df8-bff2-f72a9cc78069.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1114198rivaroxaban 10 MG Oral TabletPSN65727928-9421-4df8-bff2-f72a9cc780697
1114202Xarelto 10 MG Oral TabletPSN65727928-9421-4df8-bff2-f72a9cc780697
1114202rivaroxaban 10 MG Oral Tablet [Xarelto]SBD65727928-9421-4df8-bff2-f72a9cc780697
1114198rivaroxaban 10 MG Oral TabletSCD65727928-9421-4df8-bff2-f72a9cc780697
1114202Xarelto 10 MG Oral TabletSY65727928-9421-4df8-bff2-f72a9cc780697

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-4469-05009044690090 TABLET, FILM COATED in 1 BOTTLE (50090-4469-0) 2019-08-160000-00-00NoNoCurrent