FDA.reportPublic FDA data

Rivaroxaban

Product NDC
14445-184
11-digit product format
144450184
Labeler code
14445
Product ID
14445-184_b57414a3-eca8-4cda-b7eb-7c060d52a6b6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rivaroxaban
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Indoco Remedies Limited
Application
ANDA218445
Marketing category
ANDA
Marketing start
2025-08-11
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
Rivaroxaban
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
RIVAROXABAN20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9NDF7JZ4M3
Rxcui1114198, 1232082, 1232086, 2059015

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
14445-184-00Rivaroxaban1000 in 1 BOTTLETABLET, FILM COATED10002
14445-184-02Rivaroxaban10 in 1 BLISTER PACKTABLET, FILM COATED102
14445-184-10Rivaroxaban10 in 1 CARTONTABLET, FILM COATED102
14445-184-30Rivaroxaban30 in 1 BOTTLETABLET, FILM COATED302
14445-184-90Rivaroxaban90 in 1 BOTTLETABLET, FILM COATED902

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1114198rivaroxaban 10 MG Oral TabletPSN9fee7136-c8fd-4bea-ab15-7a0e7292396d2
1232082rivaroxaban 15 MG Oral TabletPSN9fee7136-c8fd-4bea-ab15-7a0e7292396d2
2059015rivaroxaban 2.5 MG Oral TabletPSN9fee7136-c8fd-4bea-ab15-7a0e7292396d2
1232086rivaroxaban 20 MG Oral TabletPSN9fee7136-c8fd-4bea-ab15-7a0e7292396d2
1114198rivaroxaban 10 MG Oral TabletSCD9fee7136-c8fd-4bea-ab15-7a0e7292396d2
1232082rivaroxaban 15 MG Oral TabletSCD9fee7136-c8fd-4bea-ab15-7a0e7292396d2
2059015rivaroxaban 2.5 MG Oral TabletSCD9fee7136-c8fd-4bea-ab15-7a0e7292396d2
1232086rivaroxaban 20 MG Oral TabletSCD9fee7136-c8fd-4bea-ab15-7a0e7292396d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
14445-184-00144450184001000 TABLET, FILM COATED in 1 BOTTLE (14445-184-00) 2025-08-11NoNoHistorical
14445-184-021444501840210 in 1 BLISTER PACKHistorical
14445-184-101444501841010 BLISTER PACK in 1 CARTON (14445-184-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK (14445-184-02) 10 blister pack2025-08-11NoNoHistorical
14445-184-301444501843030 TABLET, FILM COATED in 1 BOTTLE (14445-184-30) 2025-08-11NoNoHistorical
14445-184-901444501849090 TABLET, FILM COATED in 1 BOTTLE (14445-184-90) 2025-08-11NoNoHistorical