FDA.reportPublic FDA data

XARELTO

Product NDC
50090-3639
11-digit product format
500903639
Labeler code
50090
Product ID
50090-3639_e5d5aa2f-de19-4bad-a5c4-1136fe148975
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
2011-11-05
Substance
RIVAROXABAN
Active strength
20 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
RIVAROXABAN20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9NDF7JZ4M3
Rxcui1232086, 1232088

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
50090-3639-02024-07-12C16284748780-1f386c649-d6b3-0266-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
50090-3639-02023-01-30C16284748780-1f386c649-d6b3-0266-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
50090-3639-0XARELTO90 in 1 BOTTLETABLET, FILM COATED9011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3639-0EA - Each50090-363987697cb5-79e6-4d89-8521-19375bbc578212021-10-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3639XARELTO (RIVAROXABAN) TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]11Current NDC, Legacy NDC, 1 package rows20240712_3e95389b-0a93-4560-98c5-02637fb2600f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1232086rivaroxaban 20 MG Oral TabletPSN3e95389b-0a93-4560-98c5-02637fb2600f11
1232088Xarelto 20 MG Oral TabletPSN3e95389b-0a93-4560-98c5-02637fb2600f11
1232088rivaroxaban 20 MG Oral Tablet [Xarelto]SBD3e95389b-0a93-4560-98c5-02637fb2600f11
1232086rivaroxaban 20 MG Oral TabletSCD3e95389b-0a93-4560-98c5-02637fb2600f11
1232088Xarelto 20 MG Oral TabletSY3e95389b-0a93-4560-98c5-02637fb2600f11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-3639-05009036390090 TABLET, FILM COATED in 1 BOTTLE (50090-3639-0) 2018-10-080000-00-00NoNoCurrent