FDA.reportPublic FDA data

Rivaroxaban

Product NDC
33342-488
11-digit product format
333420488
Labeler code
33342
Product ID
33342-488_b6691115-e5df-4846-8358-79d091cdc3c0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rivaroxaban
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Macleods Pharmaceuticals Limited
Application
ANDA213114
Marketing category
ANDA
Marketing start
2025-05-14
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Rivaroxaban
Listing expiration
2027-12-31

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
33342-488-09Rivaroxaban60 in 1 BOTTLETABLET, FILM COATED604
33342-488-57Rivaroxaban180 in 1 BOTTLETABLET, FILM COATED1804
33342-488-98Rivaroxaban10 in 1 CARTONTABLET, FILM COATED104
33342-488-98Rivaroxaban6 in 1 BLISTER PACKTABLET, FILM COATED64

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33342-488-09EA - Each33342-48823337fc5-55ad-47d5-b169-c971e9c8b01f12025-06-13
33342-488-57EA - Each33342-488608871e9-0e07-40d5-a93b-1524871c3ac812025-06-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33342-488RIVAROXABAN TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]2Current NDC, 4 package rows20250522_57717a31-d9d3-4246-90c0-4e4c0a29adf5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2059015rivaroxaban 2.5 MG Oral TabletPSN57717a31-d9d3-4246-90c0-4e4c0a29adf54
2059015rivaroxaban 2.5 MG Oral TabletSCD57717a31-d9d3-4246-90c0-4e4c0a29adf54

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
33342-488-093334204880960 TABLET, FILM COATED in 1 BOTTLE (33342-488-09) 2025-05-14NoNoHistorical
33342-488-5733342048857180 TABLET, FILM COATED in 1 BOTTLE (33342-488-57) 2025-05-14NoNoHistorical
33342-488-983334204889810 BLISTER PACK in 1 CARTON (33342-488-98) / 6 TABLET, FILM COATED in 1 BLISTER PACK10 blister pack2025-05-14NoNoHistorical