RIVAROXABAN

Product NDC
72865-321
11-digit product format
728650321
Labeler code
72865
Product ID
72865-321_a24524f3-072e-4484-b6c8-77c70e4e3005
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
RIVAROXABAN
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
XLCare Pharmaceuticals, Inc.
Application
ANDA219332
Marketing category
ANDA
Marketing start
2025-12-17
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
RIVAROXABAN2.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9NDF7JZ4M3
Rxcui2059015

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6cd5c957-f63d-4ae5-a5e5-4e6830870998Product name320251209

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72865-321-18RIVAROXABAN180 in 1 BOTTLETABLET, FILM COATED1801
72865-321-60RIVAROXABAN60 in 1 BOTTLETABLET, FILM COATED601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72865-321-18EA - Each72865-321425db1d6-1518-45d9-a62a-e4087b8e328812026-02-05
72865-321-60EA - Each72865-321701568e4-e230-4a16-89b0-9595944cae7f12026-02-05

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2059015rivaroxaban 2.5 MG Oral TabletPSN291011aa-60eb-4109-b59c-1c521fbeac4f1
2059015rivaroxaban 2.5 MG Oral TabletSCD291011aa-60eb-4109-b59c-1c521fbeac4f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72865-321-1872865032118180 TABLET, FILM COATED in 1 BOTTLE (72865-321-18) 2025-12-17NoNoHistorical
72865-321-607286503216060 TABLET, FILM COATED in 1 BOTTLE (72865-321-60) 2025-12-17NoNoHistorical