XARELTO

Product NDC: 50458-584
11-digit product format: 504580584
Labeler code: 50458
Product ID: 50458-584_452610f0-5abb-448d-a1fc-9dd9be02bb66
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Rivaroxaban
Dosage form: KIT
Labeler: Janssen Pharmaceuticals, Inc.
Application: NDA022406
Marketing category: NDA
Marketing start: 2014-09-16
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-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…`

Additional Listing Data#

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

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 · 12 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1114198	Internal RxNorm lookup
1114202	Internal RxNorm lookup
1232082	Internal RxNorm lookup
1232084	Internal RxNorm lookup
1232086	Internal RxNorm lookup
1232088	Internal RxNorm lookup
1549682	Internal RxNorm lookup
1549683	Internal RxNorm lookup
2059015	Internal RxNorm lookup
2059017	Internal RxNorm lookup
2588062	Internal RxNorm lookup
2588066	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
10db92f9-2300-4a80-836b-673e1ae91610	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
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508
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
50458-584-51	XARELTO	1 in 1 CARTON	KIT	1		64
50458-584-52	XARELTO	1 in 1 CARTON	KIT	1		64

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50458-584-51	EA - Each	50458-584	9fc94268-047f-4d41-aa11-e0b610005164	1	2014-11-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
rivaroxaban	ACTIVE INGREDIENT	9NDF7JZ4M3	XARELTO (RIVAROXABAN) TABLET, FILM COATED XARELTO (RIVAROXABAN) KIT [JANSSEN PHARMACEUTICALS, INC.]	17
rivaroxaban	ACTIVE MOIETY	9NDF7JZ4M3	XARELTO (RIVAROXABAN) TABLET, FILM COATED XARELTO (RIVAROXABAN) KIT [JANSSEN PHARMACEUTICALS, INC.]	17
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	XARELTO (RIVAROXABAN) TABLET, FILM COATED XARELTO (RIVAROXABAN) KIT [JANSSEN PHARMACEUTICALS, INC.]	17
croscarmellose sodium	INACTIVE INGREDIENT	M28OL1HH48	XARELTO (RIVAROXABAN) TABLET, FILM COATED XARELTO (RIVAROXABAN) KIT [JANSSEN PHARMACEUTICALS, INC.]	17
ferric oxide red	INACTIVE INGREDIENT	1K09F3G675	XARELTO (RIVAROXABAN) TABLET, FILM COATED XARELTO (RIVAROXABAN) KIT [JANSSEN PHARMACEUTICALS, INC.]	17
hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	XARELTO (RIVAROXABAN) TABLET, FILM COATED XARELTO (RIVAROXABAN) KIT [JANSSEN PHARMACEUTICALS, INC.]	17
lactose monohydrate	INACTIVE INGREDIENT	EWQ57Q8I5X	XARELTO (RIVAROXABAN) TABLET, FILM COATED XARELTO (RIVAROXABAN) KIT [JANSSEN PHARMACEUTICALS, INC.]	17
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	XARELTO (RIVAROXABAN) TABLET, FILM COATED XARELTO (RIVAROXABAN) KIT [JANSSEN PHARMACEUTICALS, INC.]	17
polyethylene glycol 3350	INACTIVE INGREDIENT	G2M7P15E5P	XARELTO (RIVAROXABAN) TABLET, FILM COATED XARELTO (RIVAROXABAN) KIT [JANSSEN PHARMACEUTICALS, INC.]	17
polyvinyl alcohol	INACTIVE INGREDIENT	532B59J990	XARELTO (RIVAROXABAN) TABLET, FILM COATED XARELTO (RIVAROXABAN) KIT [JANSSEN PHARMACEUTICALS, INC.]	17
sodium lauryl sulfate	INACTIVE INGREDIENT	368GB5141J	XARELTO (RIVAROXABAN) TABLET, FILM COATED XARELTO (RIVAROXABAN) KIT [JANSSEN PHARMACEUTICALS, INC.]	17
talc	INACTIVE INGREDIENT	7SEV7J4R1U	XARELTO (RIVAROXABAN) TABLET, FILM COATED XARELTO (RIVAROXABAN) KIT [JANSSEN PHARMACEUTICALS, INC.]	17
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	XARELTO (RIVAROXABAN) TABLET, FILM COATED XARELTO (RIVAROXABAN) KIT [JANSSEN PHARMACEUTICALS, INC.]	17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50458-584	XARELTO (RIVAROXABAN) TABLET, FILM COATED XARELTO (RIVAROXABAN) TABLET, FILM COATED XARELTO (RIVAROXABAN) KIT XARELTO (RIVAROXABAN) GRANULE, FOR SUSPENSION [JANSSEN PHARMACEUTICALS, INC.]	59	Current NDC, Legacy NDC, 2 package rows	20250409_10db92f9-2300-4a80-836b-673e1ae91610.zip

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
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): 50458-584
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
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

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
1549683	{42 (rivaroxaban 15 MG Oral Tablet [Xarelto]) / 9 (rivaroxaban 20 MG Oral Tablet [Xarelto]) } Pack [Xarelto Kit]	BPCK	10db92f9-2300-4a80-836b-673e1ae91610	64
1549682	{42 (rivaroxaban 15 MG Oral Tablet) / 9 (rivaroxaban 20 MG Oral Tablet) } Pack	GPCK	10db92f9-2300-4a80-836b-673e1ae91610	64
2588062	rivaroxaban 1 MG/mL Oral Suspension	PSN	10db92f9-2300-4a80-836b-673e1ae91610	64
1114198	rivaroxaban 10 MG Oral Tablet	PSN	10db92f9-2300-4a80-836b-673e1ae91610	64
1232082	rivaroxaban 15 MG Oral Tablet	PSN	10db92f9-2300-4a80-836b-673e1ae91610	64
2059015	rivaroxaban 2.5 MG Oral Tablet	PSN	10db92f9-2300-4a80-836b-673e1ae91610	64
1232086	rivaroxaban 20 MG Oral Tablet	PSN	10db92f9-2300-4a80-836b-673e1ae91610	64
1549682	rivaroxaban 30-Day Starter Pack (42-15 MG Oral Tablets & 9-20 MG Oral Tablets)	PSN	10db92f9-2300-4a80-836b-673e1ae91610	64
2588066	Xarelto 1 MG/mL Oral Suspension	PSN	10db92f9-2300-4a80-836b-673e1ae91610	64
1114202	Xarelto 10 MG Oral Tablet	PSN	10db92f9-2300-4a80-836b-673e1ae91610	64
1232084	Xarelto 15 MG Oral Tablet	PSN	10db92f9-2300-4a80-836b-673e1ae91610	64
2059017	Xarelto 2.5 MG Oral Tablet	PSN	10db92f9-2300-4a80-836b-673e1ae91610	64
1232088	Xarelto 20 MG Oral Tablet	PSN	10db92f9-2300-4a80-836b-673e1ae91610	64
1549683	Xarelto Starter Pack, 30-Day	PSN	10db92f9-2300-4a80-836b-673e1ae91610	64
2588066	rivaroxaban 1 MG/ML Oral Suspension [Xarelto]	SBD	10db92f9-2300-4a80-836b-673e1ae91610	64
1114202	rivaroxaban 10 MG Oral Tablet [Xarelto]	SBD	10db92f9-2300-4a80-836b-673e1ae91610	64
1232084	rivaroxaban 15 MG Oral Tablet [Xarelto]	SBD	10db92f9-2300-4a80-836b-673e1ae91610	64
2059017	rivaroxaban 2.5 MG Oral Tablet [Xarelto]	SBD	10db92f9-2300-4a80-836b-673e1ae91610	64
1232088	rivaroxaban 20 MG Oral Tablet [Xarelto]	SBD	10db92f9-2300-4a80-836b-673e1ae91610	64
2588062	rivaroxaban 1 MG/ML Oral Suspension	SCD	10db92f9-2300-4a80-836b-673e1ae91610	64
1114198	rivaroxaban 10 MG Oral Tablet	SCD	10db92f9-2300-4a80-836b-673e1ae91610	64
1232082	rivaroxaban 15 MG Oral Tablet	SCD	10db92f9-2300-4a80-836b-673e1ae91610	64
2059015	rivaroxaban 2.5 MG Oral Tablet	SCD	10db92f9-2300-4a80-836b-673e1ae91610	64
1232086	rivaroxaban 20 MG Oral Tablet	SCD	10db92f9-2300-4a80-836b-673e1ae91610	64
1549682	rivaroxaban 30-Day Starter Pack (42-15 MG Oral Tablets & 9-20 MG Oral Tablets)	SY	10db92f9-2300-4a80-836b-673e1ae91610	64
2588066	Xarelto 1 MG/ML Oral Suspension	SY	10db92f9-2300-4a80-836b-673e1ae91610	64
1114202	Xarelto 10 MG Oral Tablet	SY	10db92f9-2300-4a80-836b-673e1ae91610	64
1232084	Xarelto 15 MG Oral Tablet	SY	10db92f9-2300-4a80-836b-673e1ae91610	64
2059017	Xarelto 2.5 MG Oral Tablet	SY	10db92f9-2300-4a80-836b-673e1ae91610	64
1232088	Xarelto 20 MG Oral Tablet	SY	10db92f9-2300-4a80-836b-673e1ae91610	64
1549683	Xarelto 30-Day Starter Pack Kit	SY	10db92f9-2300-4a80-836b-673e1ae91610	64

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50458-584-51	50458058451	1 KIT in 1 CARTON (50458-584-51) * 42 TABLET, FILM COATED in 1 BLISTER PACK * 9 TABLET, FILM COATED in 1 BLISTER PACK	1 kit	2014-09-16	0000-00-00	No	No	Current
50458-584-52	50458058452	1 KIT in 1 CARTON (50458-584-52) * 42 TABLET, FILM COATED in 1 BLISTER PACK * 9 TABLET, FILM COATED in 1 BLISTER PACK	1 kit	2016-11-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
XARELTO	Janssen Pharmaceuticals, Inc. \| AndersonBrecon Inc. \| Patheon, Inc. \| Bayer AG \| Bayer Aktiengesellschaft \| LUSOMEDICAMENTA - SOCIEDADE TÉCNICA FARMACÊUTICA, S.A. \| Johnson & Johnson Private Limited \| Janssen Ortho LLC	2026-01-16	HUMAN PRESCRIPTION DRUG LABEL	64