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

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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N022406-001	XARELTO	RIVAROXABAN	10MG	TABLET / ORAL	AB	RLD	2011-07-01
N022406-002	XARELTO	RIVAROXABAN	15MG	TABLET / ORAL	AB	RLD	2011-11-04
N022406-003	XARELTO	RIVAROXABAN	20MG	TABLET / ORAL	AB	RLD, RS	2011-11-04
N022406-004	XARELTO	RIVAROXABAN	2.5MG	TABLET / ORAL	AB	RLD	2018-10-11

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
N022406-001	AB
N022406-002	AB
N022406-003	AB
N022406-004	AB

Orange Book patents#

Current patent rows page 1 of 1 · 13 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N022406-001	9539218	2034-02-17	U-1957		2017-02-07
N022406-001	9539218	2034-02-17	U-2143		2017-02-07
N022406-001	9539218	2034-02-17	U-2641		2017-02-07
N022406-001	9539218	2034-02-17	U-3288		2017-02-07
N022406-001	9539218*PED	2034-08-17		Pediatric extension
N022406-002	9539218	2034-02-17	U-1953		2017-02-07
N022406-002	9539218	2034-02-17	U-3289		2017-02-07
N022406-002	9539218*PED	2034-08-17		Pediatric extension
N022406-003	9539218	2034-02-17	U-1953		2017-02-07
N022406-003	9539218	2034-02-17	U-1954		2017-02-07
N022406-003	9539218	2034-02-17	U-1955		2017-02-07
N022406-003	9539218	2034-02-17	U-3285		2017-02-07
N022406-003	9539218*PED	2034-08-17		Pediatric extension

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	N022406-001	XARELTO	10MG	TABLET / ORAL	AB	RLD	2011-07-01	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022406-002	XARELTO	15MG	TABLET / ORAL	AB	RLD	2011-11-04	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022406-003	XARELTO	20MG	TABLET / ORAL	AB	RLD, RS	2011-11-04	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022406-004	XARELTO	2.5MG	TABLET / ORAL	AB	RLD	2018-10-11	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	N022406-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022406-002	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022406-003	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022406-004	AB	1	`a50c72e98297…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-01 22:54:32	2026-06	N022406-001	9539218	2034-02-17	U-1957		2017-02-07	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022406-001	9539218	2034-02-17	U-2641		2017-02-07	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022406-001	9539218	2034-02-17	U-2143		2017-02-07	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022406-001	9539218	2034-02-17	U-3288		2017-02-07	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022406-001	9539218*PED	2034-08-17		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022406-002	9539218	2034-02-17	U-1953		2017-02-07	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022406-002	9539218	2034-02-17	U-3289		2017-02-07	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022406-002	9539218*PED	2034-08-17		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022406-003	9539218	2034-02-17	U-1955		2017-02-07	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022406-003	9539218	2034-02-17	U-1954		2017-02-07	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022406-003	9539218	2034-02-17	U-1953		2017-02-07	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022406-003	9539218	2034-02-17	U-3285		2017-02-07	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022406-003	9539218*PED	2034-08-17		Pediatric extension		`a50c72e98297…`

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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Xarelto	RIVAROXABAN	Cardinal Health 107, LLC	d0e105f6-28f3-45ee-83bd-7d458835242b	2026-02-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 022406 application number: NDA022406
Xarelto	RIVAROXABAN	Janssen Pharmaceuticals, Inc.	10db92f9-2300-4a80-836b-673e1ae91610	2026-01-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 022406 application number: NDA022406
Xarelto	RIVAROXABAN	A-S Medication Solutions	e76bf2cf-a8b8-4471-a8ce-57c918b11a48	2024-09-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 022406 application number: NDA022406
Xarelto	RIVAROXABAN	A-S Medication Solutions	65727928-9421-4df8-bff2-f72a9cc78069	2024-05-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 022406 application number: NDA022406
Xarelto	RIVAROXABAN	A-S Medication Solutions	7e9ab975-db2f-423c-a089-bc5a73313609	2024-05-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 022406 application number: NDA022406
XARELTO	RIVAROXABAN	A-S Medication Solutions	3e95389b-0a93-4560-98c5-02637fb2600f	2023-11-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 022406 application number: NDA022406
Xarelto	RIVAROXABAN	Aphena Pharma Solutions - Tennessee, LLC	38b11f5d-f0fc-46dc-aef1-ea31872bb621	2023-02-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 022406 application number: NDA022406 ndc (product): 71610-690

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
RIVAROXABAN	10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
9NDF7JZ4M3	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1114198	Internal RxNorm lookup
1114202	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
38b11f5d-f0fc-46dc-aef1-ea31872bb621	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6cd5c957-f63d-4ae5-a5e5-4e6830870998	Product name	3	20251209
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
71610-690-42	Xarelto	1800 in 1 BOTTLE	TABLET, FILM COATED	1800		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71610-690-42	EA - Each	71610-690	254c5ece-23ee-4218-abe4-51bda6ae5ff6	1	2024-01-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71610-690	XARELTO (RIVAROXABAN) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1	Current NDC, 1 package rows	20230221_38b11f5d-f0fc-46dc-aef1-ea31872bb621.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
9NDF7JZ4M3	RIVAROXABAN	366789-02-8	RIVAROXABAN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1114198	rivaroxaban 10 MG Oral Tablet	PSN	38b11f5d-f0fc-46dc-aef1-ea31872bb621	1
1114202	Xarelto 10 MG Oral Tablet	PSN	38b11f5d-f0fc-46dc-aef1-ea31872bb621	1
1114202	rivaroxaban 10 MG Oral Tablet [Xarelto]	SBD	38b11f5d-f0fc-46dc-aef1-ea31872bb621	1
1114198	rivaroxaban 10 MG Oral Tablet	SCD	38b11f5d-f0fc-46dc-aef1-ea31872bb621	1
1114202	Xarelto 10 MG Oral Tablet	SY	38b11f5d-f0fc-46dc-aef1-ea31872bb621	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
71610-690-42	71610069042	1800 TABLET, FILM COATED in 1 BOTTLE (71610-690-42)	2023-02-17	No	No	Current