Xarelto

Product NDC
71610-690
11-digit product format
716100690
Labeler code
71610
Product ID
71610-690_d0758929-1cc8-4ac2-807e-969a8c7f6c77
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
rivaroxaban
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71610-690-42Xarelto1800 in 1 BOTTLETABLET, FILM COATED18001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-690-42EA - Each71610-690254c5ece-23ee-4218-abe4-51bda6ae5ff612024-01-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-690XARELTO (RIVAROXABAN) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Current NDC, 1 package rows20230221_38b11f5d-f0fc-46dc-aef1-ea31872bb621.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1114198rivaroxaban 10 MG Oral TabletPSN38b11f5d-f0fc-46dc-aef1-ea31872bb6211
1114202Xarelto 10 MG Oral TabletPSN38b11f5d-f0fc-46dc-aef1-ea31872bb6211
1114202rivaroxaban 10 MG Oral Tablet [Xarelto]SBD38b11f5d-f0fc-46dc-aef1-ea31872bb6211
1114198rivaroxaban 10 MG Oral TabletSCD38b11f5d-f0fc-46dc-aef1-ea31872bb6211
1114202Xarelto 10 MG Oral TabletSY38b11f5d-f0fc-46dc-aef1-ea31872bb6211

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71610-690-42716100690421800 TABLET, FILM COATED in 1 BOTTLE (71610-690-42) 2023-02-17NoNoCurrent