XARELTO

Product NDC: 50090-3639
11-digit product format: 500903639
Labeler code: 50090
Product ID: 50090-3639_e5d5aa2f-de19-4bad-a5c4-1136fe148975
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: rivaroxaban
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: A-S Medication Solutions
Application: NDA022406
Marketing category: NDA
Marketing start: 2011-11-05
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

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 8 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	50090-3639-0	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	50090-3639-0	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	50090-3639-0	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	50090-3639-0	`1332a3947898…`	`d4bfe170f9cd…`

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: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
RIVAROXABAN	20 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
1232086	Internal RxNorm lookup
1232088	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
3e95389b-0a93-4560-98c5-02637fb2600f	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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50090-3639-0	2024-07-12	C162847	48780-1	f386c649-d6b3-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use XARELTO safely and effectively. See full prescribing information for XARELTO. XARELTO ® (rivaroxaban) tablets, for oral use XARELTO ® (rivaroxaban) for oral suspension Initial U.S. Approval: 2011
50090-3639-0	2023-01-30	C162847	48780-1	f386c649-d6b3-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use XARELTO safely and effectively. See full prescribing information for XARELTO. XARELTO ® (rivaroxaban) tablets, for oral use XARELTO ® (rivaroxaban) for oral suspension Initial U.S. Approval: 2011

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50090-3639-0	XARELTO	90 in 1 BOTTLE	TABLET, FILM COATED	90		11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-3639-0	EA - Each	50090-3639	87697cb5-79e6-4d89-8521-19375bbc5782	1	2021-10-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-3639	XARELTO (RIVAROXABAN) TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]	11	Current NDC, Legacy NDC, 1 package rows	20240712_3e95389b-0a93-4560-98c5-02637fb2600f.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
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 ndc (product): 50090-3639
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
1232086	rivaroxaban 20 MG Oral Tablet	PSN	3e95389b-0a93-4560-98c5-02637fb2600f	11
1232088	Xarelto 20 MG Oral Tablet	PSN	3e95389b-0a93-4560-98c5-02637fb2600f	11
1232088	rivaroxaban 20 MG Oral Tablet [Xarelto]	SBD	3e95389b-0a93-4560-98c5-02637fb2600f	11
1232086	rivaroxaban 20 MG Oral Tablet	SCD	3e95389b-0a93-4560-98c5-02637fb2600f	11
1232088	Xarelto 20 MG Oral Tablet	SY	3e95389b-0a93-4560-98c5-02637fb2600f	11

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-3639-0	50090363900	90 TABLET, FILM COATED in 1 BOTTLE (50090-3639-0)	2018-10-08	0000-00-00	No	No	Current