FDA.reportPublic FDA data

Rivaroxaban

Product NDC
72205-416
11-digit product format
722050416
Labeler code
72205
Product ID
72205-416_e8e4275c-6cbe-4976-8cae-f62baf954d27
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rivaroxaban
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Novadoz Pharmaceuticals LLC
Application
ANDA208546
Marketing category
ANDA
Marketing start
2025-10-24
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A208546-001RIVAROXABANRIVAROXABAN2.5MGTABLET / ORALAB2025-10-24
A208546-002RIVAROXABANRIVAROXABAN10MGTABLET / ORAL2025-10-24
A208546-003RIVAROXABANRIVAROXABAN15MGTABLET / ORAL2025-10-24
A208546-004RIVAROXABANRIVAROXABAN20MGTABLET / ORAL2025-10-24

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A208546-001AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A208546-001RIVAROXABAN2.5MGTABLET / ORALAB2025-10-24a50c72e98297…
2026-08-01 22:54:322026-06A208546-002RIVAROXABAN10MGTABLET / ORAL2025-10-24a50c72e98297…
2026-08-01 22:54:322026-06A208546-003RIVAROXABAN15MGTABLET / ORAL2025-10-24a50c72e98297…
2026-08-01 22:54:322026-06A208546-004RIVAROXABAN20MGTABLET / ORAL2025-10-24a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A208546-001AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RivaroxabanRIVAROXABANNovadoz Pharmaceuticals LLCe8e4275c-6cbe-4976-8cae-f62baf954d272026-03-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208546
application number: ANDA208546
ndc (product): 72205-416

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9NDF7JZ4M3Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2059015Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
e8e4275c-6cbe-4976-8cae-f62baf954d27Available on FDA.report

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
72205-416-02Rivaroxaban10 in 1 BLISTER PACKTABLET, FILM COATED101
72205-416-02Rivaroxaban10 in 1 CARTONTABLET, FILM COATED101
72205-416-03Rivaroxaban30 in 1 BOTTLETABLET, FILM COATED301
72205-416-04Rivaroxaban60 in 1 BOTTLETABLET, FILM COATED601
72205-416-05Rivaroxaban180 in 1 BOTTLETABLET, FILM COATED1801

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2059015rivaroxaban 2.5 MG Oral TabletPSNe8e4275c-6cbe-4976-8cae-f62baf954d271
2059015rivaroxaban 2.5 MG Oral TabletSCDe8e4275c-6cbe-4976-8cae-f62baf954d271

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72205-416-027220504160210 BLISTER PACK in 1 CARTON (72205-416-02) / 10 TABLET, FILM COATED in 1 BLISTER PACK10 blister pack2026-03-18NoNoCurrent
72205-416-037220504160330 TABLET, FILM COATED in 1 BOTTLE (72205-416-03) 2026-03-18NoNoCurrent
72205-416-047220504160460 TABLET, FILM COATED in 1 BOTTLE (72205-416-04) 2026-03-18NoNoCurrent
72205-416-0572205041605180 TABLET, FILM COATED in 1 BOTTLE (72205-416-05) 2026-03-18NoNoCurrent