Application 022406

Type: NDA
Sponsor: JANSSEN PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	XARELTO	RIVAROXABAN	TABLET;ORAL	10MG	Yes	No
002	XARELTO	RIVAROXABAN	TABLET;ORAL	15MG	Yes	No
003	XARELTO	RIVAROXABAN	TABLET;ORAL	20MG	Yes	Yes
004	XARELTO	RIVAROXABAN	TABLET;ORAL	2.5MG	Yes	No

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.

Product history page 1 of 5 · 164 observed 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
2026-02-19 14:30 UTC	2026-02	N022406-001	XARELTO	10MG	TABLET / ORAL	AB	RLD	2011-07-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022406-002	XARELTO	15MG	TABLET / ORAL	AB	RLD	2011-11-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022406-003	XARELTO	20MG	TABLET / ORAL	AB	RLD, RS	2011-11-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022406-004	XARELTO	2.5MG	TABLET / ORAL	AB	RLD	2018-10-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022406-001	XARELTO	10MG	TABLET / ORAL	AB	RLD	2011-07-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022406-002	XARELTO	15MG	TABLET / ORAL	AB	RLD	2011-11-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022406-003	XARELTO	20MG	TABLET / ORAL	AB	RLD, RS	2011-11-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022406-004	XARELTO	2.5MG	TABLET / ORAL	AB	RLD	2018-10-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022406-001	XARELTO	10MG	TABLET / ORAL	AB	RLD	2011-07-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022406-002	XARELTO	15MG	TABLET / ORAL	AB	RLD	2011-11-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022406-003	XARELTO	20MG	TABLET / ORAL	AB	RLD, RS	2011-11-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022406-004	XARELTO	2.5MG	TABLET / ORAL	AB	RLD	2018-10-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022406-001	XARELTO	10MG	TABLET / ORAL		RLD	2011-07-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022406-002	XARELTO	15MG	TABLET / ORAL		RLD	2011-11-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022406-003	XARELTO	20MG	TABLET / ORAL		RLD, RS	2011-11-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022406-004	XARELTO	2.5MG	TABLET / ORAL	AB	RLD	2018-10-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022406-001	XARELTO	10MG	TABLET / ORAL		RLD	2011-07-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022406-002	XARELTO	15MG	TABLET / ORAL		RLD	2011-11-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022406-003	XARELTO	20MG	TABLET / ORAL		RLD, RS	2011-11-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022406-004	XARELTO	2.5MG	TABLET / ORAL		RLD	2018-10-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022406-001	XARELTO	10MG	TABLET / ORAL		RLD	2011-07-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022406-002	XARELTO	15MG	TABLET / ORAL		RLD	2011-11-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022406-003	XARELTO	20MG	TABLET / ORAL		RLD, RS	2011-11-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022406-004	XARELTO	2.5MG	TABLET / ORAL		RLD	2018-10-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022406-001	XARELTO	10MG	TABLET / ORAL		RLD	2011-07-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022406-002	XARELTO	15MG	TABLET / ORAL		RLD	2011-11-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022406-003	XARELTO	20MG	TABLET / ORAL		RLD, RS	2011-11-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022406-004	XARELTO	2.5MG	TABLET / ORAL		RLD	2018-10-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022406-001	XARELTO	10MG	TABLET / ORAL		RLD	2011-07-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022406-002	XARELTO	15MG	TABLET / ORAL		RLD	2011-11-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022406-003	XARELTO	20MG	TABLET / ORAL		RLD, RS	2011-11-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022406-004	XARELTO	2.5MG	TABLET / ORAL		RLD	2018-10-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022406-001	XARELTO	10MG	TABLET / ORAL		RLD	2011-07-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022406-002	XARELTO	15MG	TABLET / ORAL		RLD	2011-11-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022406-003	XARELTO	20MG	TABLET / ORAL		RLD, RS	2011-11-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022406-004	XARELTO	2.5MG	TABLET / ORAL		RLD	2018-10-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022406-001	XARELTO	10MG	TABLET / ORAL		RLD	2011-07-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022406-002	XARELTO	15MG	TABLET / ORAL		RLD	2011-11-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022406-003	XARELTO	20MG	TABLET / ORAL		RLD, RS	2011-11-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022406-004	XARELTO	2.5MG	TABLET / ORAL		RLD	2018-10-11	`d06236e962d9…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N022406-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022406-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022406-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022406-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022406-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022406-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022406-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022406-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022406-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022406-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022406-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022406-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022406-004	AB	1	`fd3edfee7708…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N022406-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N022406-002	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N022406-003	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N022406-004	AB	1	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 44 · 1,757 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N022406-001	9539218	2034-02-17	U-1957		2017-02-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022406-001	9539218	2034-02-17	U-2641		2017-02-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022406-001	9539218	2034-02-17	U-2143		2017-02-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022406-001	9539218	2034-02-17	U-3288		2017-02-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022406-001	9539218*PED	2034-08-17		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022406-002	9539218	2034-02-17	U-1953		2017-02-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022406-002	9539218	2034-02-17	U-3289		2017-02-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022406-002	9539218*PED	2034-08-17		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022406-003	9539218	2034-02-17	U-1955		2017-02-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022406-003	9539218	2034-02-17	U-1954		2017-02-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022406-003	9539218	2034-02-17	U-1953		2017-02-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022406-003	9539218	2034-02-17	U-3285		2017-02-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022406-003	9539218*PED	2034-08-17		Pediatric extension		`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022406-001	7157456	2024-08-28	U-1302	Drug substance, Drug product	2011-08-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022406-001	7157456	2024-08-28	U-1301	Drug substance, Drug product	2011-08-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022406-001	9415053	2024-11-13	U-2640	Drug product	2016-09-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022406-001	9415053	2024-11-13	U-3284	Drug product	2016-09-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022406-001	9415053	2024-11-13	U-2142	Drug product	2016-09-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022406-001	9415053	2024-11-13	U-1167	Drug product	2016-09-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022406-001	7157456*PED	2025-02-28		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022406-001	9415053*PED	2025-05-13		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022406-001	9539218	2034-02-17	U-1957		2017-02-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022406-001	9539218	2034-02-17	U-2641		2017-02-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022406-001	9539218	2034-02-17	U-2143		2017-02-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022406-001	9539218	2034-02-17	U-3288		2017-02-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022406-001	9539218*PED	2034-08-17		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022406-002	7157456	2024-08-28	U-1302	Drug substance, Drug product	2011-12-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022406-002	7157456	2024-08-28	U-1301	Drug substance, Drug product	2011-12-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022406-002	9415053	2024-11-13	U-1200	Drug product	2016-09-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022406-002	9415053	2024-11-13	U-1302	Drug product	2016-09-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022406-002	9415053	2024-11-13	U-3286	Drug product	2016-09-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022406-002	9415053	2024-11-13	U-1301	Drug product	2016-09-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022406-002	7157456*PED	2025-02-28		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022406-002	9415053*PED	2025-05-13		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022406-002	9539218	2034-02-17	U-1953		2017-02-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022406-002	9539218	2034-02-17	U-3289		2017-02-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022406-002	9539218*PED	2034-08-17		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022406-003	7157456	2024-08-28	U-1302	Drug substance, Drug product	2011-12-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022406-003	7157456	2024-08-28	U-1301	Drug substance, Drug product	2011-12-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022406-003	9415053	2024-11-13	U-1200	Drug product	2016-09-14	`31067a03dcf5…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 12 · 443 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022406-001	I-867	2024-08-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022406-001	PED	2025-02-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022406-002	I-867	2024-08-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022406-002	PED	2025-02-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022406-003	I-867	2024-08-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022406-003	PED	2025-02-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022406-004	I-867	2024-08-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022406-004	PED	2025-02-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022406-001	I-867	2024-08-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022406-001	PED	2025-02-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022406-002	I-867	2024-08-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022406-002	PED	2025-02-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022406-003	I-867	2024-08-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022406-003	PED	2025-02-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022406-004	I-867	2024-08-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022406-004	PED	2025-02-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022406-001	I-867	2024-08-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022406-001	PED	2025-02-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022406-002	I-867	2024-08-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022406-002	PED	2025-02-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022406-003	I-867	2024-08-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022406-003	PED	2025-02-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022406-004	I-867	2024-08-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022406-004	PED	2025-02-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022406-001	I-867	2024-08-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022406-001	PED	2025-02-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022406-002	I-867	2024-08-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022406-002	PED	2025-02-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022406-003	I-867	2024-08-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022406-003	PED	2025-02-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022406-004	I-867	2024-08-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022406-004	PED	2025-02-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022406-001	I-867	2024-08-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022406-001	PED	2025-02-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022406-002	I-867	2024-08-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022406-002	PED	2025-02-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022406-003	I-867	2024-08-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022406-003	PED	2025-02-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022406-004	I-867	2024-08-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022406-004	PED	2025-02-23	`03ed91905a0d…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown 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 ndc (product): 55154-1422
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 ndc (product): 50458-578 ndc (product): 50458-580 ndc (product): 50458-579 ndc (product): 50458-577 ndc (product): 50458-584
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 ndc (product): 50090-4469
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 ndc (product): 50090-3625
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 Listings For This Application#

NDC listings for this application page 1 of 1 · 54 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-3625	Xarelto	rivaroxaban	A-S Medication Solutions	NDA	Current
50090-3625	Xarelto	rivaroxaban	A-S Medication Solutions	NDA	Current
50090-4469	Xarelto	rivaroxaban	A-S Medication Solutions	NDA	Current
50090-4469	Xarelto	rivaroxaban	A-S Medication Solutions	NDA	Current
50458-577	XARELTO	rivaroxaban	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-577	XARELTO	rivaroxaban	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-578	Xarelto	rivaroxaban	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-578	Xarelto	rivaroxaban	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-579	Xarelto	rivaroxaban	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-579	Xarelto	rivaroxaban	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-580	Xarelto	rivaroxaban	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-580	Xarelto	rivaroxaban	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-580	Xarelto	rivaroxaban	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-580	Xarelto	rivaroxaban	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-580	Xarelto	rivaroxaban	Janssen Pharmaceuticals,	NDA	Current
50458-580	Xarelto	rivaroxaban	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-580	Xarelto	rivaroxaban	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-580	Xarelto	rivaroxaban	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-580	Xarelto	rivaroxaban	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-580	Xarelto	rivaroxaban	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-580	Xarelto	rivaroxaban	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-580	Xarelto	rivaroxaban	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-580	Xarelto	rivaroxaban	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-580	Xarelto	rivaroxaban	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-580	Xarelto	rivaroxaban	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-580	Xarelto	rivaroxaban	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-584	XARELTO	Rivaroxaban	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-584	XARELTO	Rivaroxaban	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-584	XARELTO	Rivaroxaban	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-584	XARELTO	Rivaroxaban	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-584	XARELTO	Rivaroxaban	Janssen Pharmaceuticals,	NDA	Current
50458-584	XARELTO	Rivaroxaban	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-584	XARELTO	Rivaroxaban	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-584	XARELTO	Rivaroxaban	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-584	XARELTO	Rivaroxaban	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-584	XARELTO	Rivaroxaban	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-584	XARELTO	Rivaroxaban	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-584	XARELTO	Rivaroxaban	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-584	XARELTO	Rivaroxaban	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-584	XARELTO	Rivaroxaban	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-584	XARELTO	Rivaroxaban	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-584	XARELTO	Rivaroxaban	Janssen Pharmaceuticals, Inc.	NDA	Current
55154-1422	Xarelto	rivaroxaban	Cardinal Health.	NDA	Current
55154-1422	Xarelto	rivaroxaban	Cardinal Health.	NDA	Current
55154-1422	Xarelto	rivaroxaban	Cardinal Health 107, LLC	NDA	Current
55154-1422	Xarelto	rivaroxaban	Cardinal Health.	NDA	Current
55154-1422	Xarelto	rivaroxaban	Cardinal Health.	NDA	Current
55154-1422	Xarelto	rivaroxaban	Cardinal Health.	NDA	Current
55154-1422	Xarelto	rivaroxaban	Cardinal Health 107, LLC	NDA	Current
55154-1422	Xarelto	rivaroxaban	Cardinal Health.	NDA	Current
55154-1422	Xarelto	rivaroxaban	Cardinal Health.	NDA	Current
55154-1422	Xarelto	rivaroxaban	Cardinal Health.	NDA	Current
55154-1422	Xarelto	rivaroxaban	Cardinal Health.	NDA	Current
55154-1422	Xarelto	rivaroxaban	Cardinal Health.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85553	SUPPL	2026-03-27
85533	SUPPL	2026-03-26
85539	SUPPL	2026-03-24
82602	SUPPL	2025-06-20
82599	SUPPL	2025-06-20
82597	SUPPL	2025-06-18
73426	SUPPL	2023-02-09
73423	SUPPL	2023-02-09
70373	SUPPL	2022-03-02
70372	SUPPL	2022-03-02
70355	SUPPL	2022-03-02
68462	SUPPL	2021-08-25
68461	SUPPL	2021-08-25
68453	SUPPL	2021-08-25
66024	SUPPL	2021-01-29
66023	SUPPL	2021-01-29
66021	SUPPL	2021-01-29
62124	SUPPL	2020-03-11
62119	SUPPL	2020-03-11
62117	SUPPL	2020-03-11
61025	SUPPL	2019-11-22
61022	SUPPL	2019-11-22
60900	SUPPL	2019-11-19
60564	SUPPL	2019-10-15
60543	SUPPL	2019-10-11
59865	SUPPL	2019-08-28
59844	SUPPL	2019-08-27
57306	SUPPL	2019-01-22
57305	SUPPL	2019-01-22
57226	SUPPL	2019-01-17
57227	SUPPL	2019-01-16
56462	SUPPL	2018-11-15
56390	SUPPL	2018-11-08
55086	SUPPL	2018-08-03
55075	SUPPL	2018-08-02
50240	SUPPL	2017-10-31
50233	SUPPL	2017-10-30
48881	SUPPL	2017-06-30
48870	SUPPL	2017-06-29
45168	SUPPL	2016-08-25
45167	SUPPL	2016-08-25
45060	SUPPL	2016-08-25
45059	SUPPL	2016-08-25
45095	SUPPL	2016-08-22
45048	SUPPL	2016-08-17
17549	SUPPL	2015-01-20
7338	SUPPL	2015-01-20
17550	SUPPL	2015-01-09
7339	SUPPL	2014-12-24
38667	SUPPL	2014-09-19
17547	SUPPL	2014-03-07
7337	SUPPL	2014-03-07
29696	SUPPL	2014-02-14
17548	SUPPL	2014-02-14
17332	SUPPL	2014-01-10
29695	SUPPL	2014-01-09
22013	ORIG	2013-09-05
17331	SUPPL	2013-03-05
7336	SUPPL	2013-03-04
38666	SUPPL	2012-11-06
29694	SUPPL	2012-11-06
29693	SUPPL	2012-11-06
17330	SUPPL	2012-11-06
17329	SUPPL	2012-11-06
7335	SUPPL	2012-11-06
17328	ORIG	2011-07-07
7334	ORIG	2011-07-07