FDA.reportPublic FDA data

Xarelto

Product NDC
50090-3625
11-digit product format
500903625
Labeler code
50090
Product ID
50090-3625_555f1ee6-225c-4834-b936-cdad8f836f81
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
50090-3625-02023-12-07C16284748780-1f386c649-c195-0266-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
50090-3625-02023-01-30C16284748780-1f386c649-c195-0266-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
50090-3625-0Xarelto90 in 1 BOTTLETABLET, FILM COATED9016
50090-3625-1Xarelto12 in 1 BOTTLETABLET, FILM COATED1216

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3625-0EA - Each50090-3625c50936ed-fbd8-4e68-aa49-f0a4cf55263812024-02-14
50090-3625-1EA - Each50090-362537bef968-41c1-404f-9d99-9df5e8cacb7312024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3625XARELTO (RIVAROXABAN) TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]16Current NDC, Legacy NDC, 2 package rows20240521_7e9ab975-db2f-423c-a089-bc5a73313609.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1114198rivaroxaban 10 MG Oral TabletPSN7e9ab975-db2f-423c-a089-bc5a7331360916
1114202Xarelto 10 MG Oral TabletPSN7e9ab975-db2f-423c-a089-bc5a7331360916
1114202rivaroxaban 10 MG Oral Tablet [Xarelto]SBD7e9ab975-db2f-423c-a089-bc5a7331360916
1114198rivaroxaban 10 MG Oral TabletSCD7e9ab975-db2f-423c-a089-bc5a7331360916
1114202Xarelto 10 MG Oral TabletSY7e9ab975-db2f-423c-a089-bc5a7331360916

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-3625-05009036250090 TABLET, FILM COATED in 1 BOTTLE (50090-3625-0) 2018-10-060000-00-00NoNoCurrent
50090-3625-15009036250112 TABLET, FILM COATED in 1 BOTTLE (50090-3625-1) 2024-05-15NoNoCurrent