XELJANZ

Product NDC: 63539-502
11-digit product format: 635390502
Labeler code: 63539
Product ID: 63539-502_3874b975-cdc0-46fe-8b73-5e0346e3a178
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: tofacitinib
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: U.S. Pharmaceuticals
Application: NDA208246
Marketing category: NDA
Marketing start: 2020-01-21
Substance: TOFACITINIB CITRATE
Active strength: 22 mg/1
Pharmacologic classes: Janus Kinase Inhibitor [EPC], Janus Kinase 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 44.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N208246-001	XELJANZ XR	TOFACITINIB CITRATE	EQ 11MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2016-02-23
N208246-002	XELJANZ XR	TOFACITINIB CITRATE	EQ 22MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2019-12-12

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
N208246-001	AB
N208246-002	AB

Orange Book patents#

Current patent rows page 1 of 1 · 18 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N208246-001	RE41783	2025-12-08		Drug substance	2016-03-18
N208246-001	RE41783*PED	2026-06-08		Pediatric extension
N208246-001	11253523	2034-03-14	U-3326		2022-03-23
N208246-001	11253523	2034-03-14	U-3327		2022-03-23
N208246-001	11253523	2034-03-14	U-3328		2022-03-23
N208246-001	11253523	2034-03-14	U-3329		2022-03-23
N208246-001	9937181	2034-03-14		Drug product	2018-05-09
N208246-001	11253523*PED	2034-09-14		Pediatric extension
N208246-001	9937181*PED	2034-09-14		Pediatric extension
N208246-002	RE41783	2025-12-08		Drug substance	2020-01-09
N208246-002	RE41783*PED	2026-06-08		Pediatric extension
N208246-002	10639309	2034-03-14		Drug product	2020-06-03
N208246-002	11253523	2034-03-14	U-3326		2022-03-23
N208246-002	11253523	2034-03-14	U-3327		2022-03-23
N208246-002	11253523	2034-03-14	U-3328		2022-03-23
N208246-002	11253523	2034-03-14	U-3329		2022-03-23
N208246-002	10639309*PED	2034-09-14		Pediatric extension
N208246-002	11253523*PED	2034-09-14		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 3 · 84 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
2026-10-15 13:18:30	2026-09	N208246-001	XELJANZ XR	EQ 11MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2016-02-23	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208246-002	XELJANZ XR	EQ 22MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2019-12-12	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N208246-001	XELJANZ XR	EQ 11MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2016-02-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208246-002	XELJANZ XR	EQ 22MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2019-12-12	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N208246-001	XELJANZ XR	EQ 11MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2016-02-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208246-002	XELJANZ XR	EQ 22MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2019-12-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N208246-001	XELJANZ XR	EQ 11MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2016-02-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208246-002	XELJANZ XR	EQ 22MG BASE	TABLET, EXTENDED RELEASE / ORAL		RLD, RS	2019-12-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208246-001	XELJANZ XR	EQ 11MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2016-02-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208246-002	XELJANZ XR	EQ 22MG BASE	TABLET, EXTENDED RELEASE / ORAL		RLD, RS	2019-12-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208246-001	XELJANZ XR	EQ 11MG BASE	TABLET, EXTENDED RELEASE / ORAL		RLD	2016-02-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208246-002	XELJANZ XR	EQ 22MG BASE	TABLET, EXTENDED RELEASE / ORAL		RLD, RS	2019-12-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208246-001	XELJANZ XR	EQ 11MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2016-02-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208246-002	XELJANZ XR	EQ 22MG BASE	TABLET, EXTENDED RELEASE / ORAL		RLD, RS	2019-12-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208246-001	XELJANZ XR	EQ 11MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2016-02-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208246-002	XELJANZ XR	EQ 22MG BASE	TABLET, EXTENDED RELEASE / ORAL		RLD, RS	2019-12-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208246-001	XELJANZ XR	EQ 11MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2016-02-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208246-002	XELJANZ XR	EQ 22MG BASE	TABLET, EXTENDED RELEASE / ORAL		RLD, RS	2019-12-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208246-001	XELJANZ XR	EQ 11MG BASE	TABLET, EXTENDED RELEASE / ORAL		RLD	2016-02-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208246-002	XELJANZ XR	EQ 22MG BASE	TABLET, EXTENDED RELEASE / ORAL		RLD, RS	2019-12-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208246-001	XELJANZ XR	EQ 11MG BASE	TABLET, EXTENDED RELEASE / ORAL		RLD	2016-02-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208246-002	XELJANZ XR	EQ 22MG BASE	TABLET, EXTENDED RELEASE / ORAL		RLD, RS	2019-12-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208246-001	XELJANZ XR	EQ 11MG BASE	TABLET, EXTENDED RELEASE / ORAL		RLD	2016-02-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208246-002	XELJANZ XR	EQ 22MG BASE	TABLET, EXTENDED RELEASE / ORAL		RLD, RS	2019-12-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208246-001	XELJANZ XR	EQ 11MG BASE	TABLET, EXTENDED RELEASE / ORAL		RLD	2016-02-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N208246-002	XELJANZ XR	EQ 22MG BASE	TABLET, EXTENDED RELEASE / ORAL		RLD, RS	2019-12-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208246-001	XELJANZ XR	EQ 11MG BASE	TABLET, EXTENDED RELEASE / ORAL		RLD	2016-02-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208246-002	XELJANZ XR	EQ 22MG BASE	TABLET, EXTENDED RELEASE / ORAL		RLD, RS	2019-12-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208246-001	XELJANZ XR	EQ 11MG BASE	TABLET, EXTENDED RELEASE / ORAL		RLD	2016-02-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208246-002	XELJANZ XR	EQ 22MG BASE	TABLET, EXTENDED RELEASE / ORAL		RLD, RS	2019-12-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208246-001	XELJANZ XR	EQ 11MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2016-02-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208246-002	XELJANZ XR	EQ 22MG BASE	TABLET, EXTENDED RELEASE / ORAL		RLD, RS	2019-12-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N208246-001	XELJANZ XR	EQ 11MG BASE	TABLET, EXTENDED RELEASE / ORAL		RLD	2016-02-23	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N208246-002	XELJANZ XR	EQ 22MG BASE	TABLET, EXTENDED RELEASE / ORAL		RLD, RS	2019-12-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208246-001	XELJANZ XR	EQ 11MG BASE	TABLET, EXTENDED RELEASE / ORAL		RLD	2016-02-23	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208246-002	XELJANZ XR	EQ 22MG BASE	TABLET, EXTENDED RELEASE / ORAL		RLD, RS	2019-12-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N208246-001	XELJANZ XR	EQ 11MG BASE	TABLET, EXTENDED RELEASE / ORAL		RLD	2016-02-23	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N208246-002	XELJANZ XR	EQ 22MG BASE	TABLET, EXTENDED RELEASE / ORAL		RLD, RS	2019-12-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N208246-001	XELJANZ XR	EQ 11MG BASE	TABLET, EXTENDED RELEASE / ORAL		RLD	2016-02-23	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N208246-002	XELJANZ XR	EQ 22MG BASE	TABLET, EXTENDED RELEASE / ORAL		RLD, RS	2019-12-12	`4b0b4de00fa7…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	N208246-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208246-002	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N208246-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208246-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N208246-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208246-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N208246-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208246-001	AB	1	`31067a03dcf5…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208246-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208246-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208246-001	AB	1	`03ed91905a0d…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208246-001	AB	1	`1e350fbaab3a…`
2021-12-28 21:50 UTC	2021-12	N208246-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N208246-002	AB	1	`782e0a99824c…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N208246-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N208246-002	AB	1	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 14 · 558 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-10-15 13:18:30	2026-09	N208246-001	RE41783	2025-12-08		Drug substance	2016-03-18	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208246-001	RE41783*PED	2026-06-08		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208246-001	11253523	2034-03-14	U-3326		2022-03-23	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208246-001	11253523	2034-03-14	U-3327		2022-03-23	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208246-001	11253523	2034-03-14	U-3328		2022-03-23	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208246-001	11253523	2034-03-14	U-3329		2022-03-23	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208246-001	9937181	2034-03-14		Drug product	2018-05-09	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208246-001	11253523*PED	2034-09-14		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208246-001	9937181*PED	2034-09-14		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208246-002	RE41783	2025-12-08		Drug substance	2020-01-09	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208246-002	RE41783*PED	2026-06-08		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208246-002	10639309	2034-03-14		Drug product	2020-06-03	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208246-002	11253523	2034-03-14	U-3326		2022-03-23	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208246-002	11253523	2034-03-14	U-3327		2022-03-23	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208246-002	11253523	2034-03-14	U-3328		2022-03-23	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208246-002	11253523	2034-03-14	U-3329		2022-03-23	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208246-002	10639309*PED	2034-09-14		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208246-002	11253523*PED	2034-09-14		Pediatric extension		`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N208246-001	RE41783	2025-12-08		Drug substance	2016-03-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208246-001	RE41783*PED	2026-06-08		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208246-001	11253523	2034-03-14	U-3326		2022-03-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208246-001	11253523	2034-03-14	U-3327		2022-03-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208246-001	11253523	2034-03-14	U-3328		2022-03-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208246-001	11253523	2034-03-14	U-3329		2022-03-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208246-001	9937181	2034-03-14		Drug product	2018-05-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208246-001	11253523*PED	2034-09-14		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208246-001	9937181*PED	2034-09-14		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208246-002	RE41783	2025-12-08		Drug substance	2020-01-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208246-002	RE41783*PED	2026-06-08		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208246-002	10639309	2034-03-14		Drug product	2020-06-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208246-002	11253523	2034-03-14	U-3326		2022-03-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208246-002	11253523	2034-03-14	U-3327		2022-03-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208246-002	11253523	2034-03-14	U-3328		2022-03-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208246-002	11253523	2034-03-14	U-3329		2022-03-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208246-002	10639309*PED	2034-09-14		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208246-002	11253523*PED	2034-09-14		Pediatric extension		`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N208246-001	RE41783	2025-12-08		Drug substance	2016-03-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208246-001	RE41783*PED	2026-06-08		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208246-001	11253523	2034-03-14	U-3326		2022-03-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208246-001	11253523	2034-03-14	U-3327		2022-03-23	`caaa826d4ba7…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208246-001	I-879	2024-12-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208246-001	I-879	2024-12-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208246-001	I-879	2024-12-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208246-001	I-879	2024-12-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208246-001	I-879	2024-12-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208246-001	I-879	2024-12-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208246-001	I-879	2024-12-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208246-001	I-879	2024-12-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N208246-001	I-879	2024-12-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208246-001	I-879	2024-12-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N208246-001	I-879	2024-12-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N208246-001	I-879	2024-12-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N208246-001	I-761	2020-12-14	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N208246-001	I-879	2024-12-14	`bb7c543d1eb4…`
2020-12-22 03:56 UTC	2020-12	N208246-001	I-761	2020-12-14	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N208246-001	I-761	2020-12-14	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N208246-001	I-761	2020-12-14	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N208246-001	I-761	2020-12-14	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N208246-001	I-761	2020-12-14	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N208246-001	I-879	2024-12-14	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N208246-001	I-879	2024-12-14	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N208246-001	I-879	2024-12-14	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N208246-001	I-879	2024-12-14	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N208246-001	I-879	2024-12-14	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N208246-001	I-879	2024-12-14	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N208246-001	I-879	2024-12-14	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N208246-001	I-879	2024-12-14	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N208246-001	I-879	2024-12-14	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N208246-001	I-879	2024-12-14	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N208246-001	I-879	2024-12-14	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N208246-001	I-879	2024-12-14	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N208246-001	I-879	2024-12-14	`cb3db0bc1861…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: XELJANZ
Brand name suffix: XR
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TOFACITINIB CITRATE	22 mg/1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
10e4c2fb-ffa2-728d-14d9-1c6c2f2b27b6	Product name	4	20250623
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#

Effective, Related label table
Effective	Related label
2021-08-14	These highlights do not include all the information needed to use XELJANZ/XELJANZ XR/XELJANZ Oral Solution safely and effectively. See full prescribing information for XELJANZ/XELJANZ XR/XELJANZ Oral Solution. XELJANZ ® (tofacitinib) tablets, for oral use XELJANZ ® XR (tofacitinib) extended-release tablets, for oral use XELJANZ ® (tofacitinib) Oral Solution Initial U.S. Approval: 2012
2021-08-14	These highlights do not include all the information needed to use XELJANZ/XELJANZ XR safely and effectively. See full prescribing information for XELJANZ/XELJANZ XR. XELJANZ ® (tofacitinib) tablets, for oral use XELJANZ ® (tofacitinib) oral solution XELJANZ ® XR (tofacitinib) extended-release tablets, for oral use Initial U.S. Approval: 2012
2021-08-14	These highlights do not include all the information needed to use XELJANZ/XELJANZ XR safely and effectively. See full prescribing information for XELJANZ/XELJANZ XR. XELJANZ ® (tofacitinib) tablets, for oral use XELJANZ ® (tofacitinib) oral solution XELJANZ ® XR (tofacitinib) extended-release tablets, for oral use Initial U.S. Approval: 2012
2021-08-14	These highlights do not include all the information needed to use XELJANZ/XELJANZ XR safely and effectively. See full prescribing information for XELJANZ/XELJANZ XR. XELJANZ ® (tofacitinib) tablets, for oral use XELJANZ ® (tofacitinib) oral solution XELJANZ ® XR (tofacitinib) extended-release tablets, for oral use Initial U.S. Approval: 2012
2021-08-14	These highlights do not include all the information needed to use XELJANZ/XELJANZ XR safely and effectively. See full prescribing information for XELJANZ/XELJANZ XR. XELJANZ ® (tofacitinib) tablets, for oral use XELJANZ ® (tofacitinib) oral solution XELJANZ ® XR (tofacitinib) extended-release tablets, for oral use Initial U.S. Approval: 2012
2021-08-14	These highlights do not include all the information needed to use XELJANZ/XELJANZ XR safely and effectively. See full prescribing information for XELJANZ/XELJANZ XR. XELJANZ ® (tofacitinib) tablets, for oral use XELJANZ ® (tofacitinib) oral solution XELJANZ ® XR (tofacitinib) extended-release tablets, for oral use Initial U.S. Approval: 2012
2021-08-14	These highlights do not include all the information needed to use XELJANZ/XELJANZ XR safely and effectively. See full prescribing information for XELJANZ/XELJANZ XR. XELJANZ ® (tofacitinib) tablets, for oral use XELJANZ ® (tofacitinib) oral solution XELJANZ ® XR (tofacitinib) extended-release tablets, for oral use Initial U.S. Approval: 2012
2021-07-23	These highlights do not include all the information needed to use XELJANZ/XELJANZ XR/XELJANZ Oral Solution safely and effectively. See full prescribing information for XELJANZ/XELJANZ XR/XELJANZ Oral Solution. XELJANZ ® (tofacitinib) tablets, for oral use XELJANZ ® XR (tofacitinib) extended-release tablets, for oral use XELJANZ ® (tofacitinib) Oral Solution Initial U.S. Approval: 2012
2021-07-23	These highlights do not include all the information needed to use XELJANZ/XELJANZ XR safely and effectively. See full prescribing information for XELJANZ/XELJANZ XR. XELJANZ ® (tofacitinib) tablets, for oral use XELJANZ ® (tofacitinib) oral solution XELJANZ ® XR (tofacitinib) extended-release tablets, for oral use Initial U.S. Approval: 2012
2021-07-23	These highlights do not include all the information needed to use XELJANZ/XELJANZ XR safely and effectively. See full prescribing information for XELJANZ/XELJANZ XR. XELJANZ ® (tofacitinib) tablets, for oral use XELJANZ ® (tofacitinib) oral solution XELJANZ ® XR (tofacitinib) extended-release tablets, for oral use Initial U.S. Approval: 2012
2021-07-23	These highlights do not include all the information needed to use XELJANZ/XELJANZ XR safely and effectively. See full prescribing information for XELJANZ/XELJANZ XR. XELJANZ ® (tofacitinib) tablets, for oral use XELJANZ ® (tofacitinib) oral solution XELJANZ ® XR (tofacitinib) extended-release tablets, for oral use Initial U.S. Approval: 2012
2021-07-23	These highlights do not include all the information needed to use XELJANZ/XELJANZ XR safely and effectively. See full prescribing information for XELJANZ/XELJANZ XR. XELJANZ ® (tofacitinib) tablets, for oral use XELJANZ ® (tofacitinib) oral solution XELJANZ ® XR (tofacitinib) extended-release tablets, for oral use Initial U.S. Approval: 2012
2021-07-23	These highlights do not include all the information needed to use XELJANZ/XELJANZ XR safely and effectively. See full prescribing information for XELJANZ/XELJANZ XR. XELJANZ ® (tofacitinib) tablets, for oral use XELJANZ ® (tofacitinib) oral solution XELJANZ ® XR (tofacitinib) extended-release tablets, for oral use Initial U.S. Approval: 2012
2021-07-23	These highlights do not include all the information needed to use XELJANZ/XELJANZ XR safely and effectively. See full prescribing information for XELJANZ/XELJANZ XR. XELJANZ ® (tofacitinib) tablets, for oral use XELJANZ ® (tofacitinib) oral solution XELJANZ ® XR (tofacitinib) extended-release tablets, for oral use Initial U.S. Approval: 2012

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63539-502-30	XELJANZXR	30 in 1 BOTTLE	TABLET, EXTENDED RELEASE	30		17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63539-502-30	EA - Each	63539-502	75697eec-67db-4b4c-8146-041ef070b608	1	2026-04-20

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
TOFACITINIB CITRATE	ACTIVE INGREDIENT	O1FF4DIV0D	XELJANZ (TOFACITINIB CITRATE) TABLET, FILM COATED [U.S. PHARMACEUTICALS]	1
TOFACITINIB	ACTIVE MOIETY	87LA6FU830	XELJANZ (TOFACITINIB CITRATE) TABLET, FILM COATED [U.S. PHARMACEUTICALS]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	XELJANZ (TOFACITINIB CITRATE) TABLET, FILM COATED [U.S. PHARMACEUTICALS]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	XELJANZ (TOFACITINIB CITRATE) TABLET, FILM COATED [U.S. PHARMACEUTICALS]	1
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	XELJANZ (TOFACITINIB CITRATE) TABLET, FILM COATED [U.S. PHARMACEUTICALS]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	XELJANZ (TOFACITINIB CITRATE) TABLET, FILM COATED [U.S. PHARMACEUTICALS]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	XELJANZ (TOFACITINIB CITRATE) TABLET, FILM COATED [U.S. PHARMACEUTICALS]	1
POLYETHYLENE GLYCOL 3350	INACTIVE INGREDIENT	G2M7P15E5P	XELJANZ (TOFACITINIB CITRATE) TABLET, FILM COATED [U.S. PHARMACEUTICALS]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	XELJANZ (TOFACITINIB CITRATE) TABLET, FILM COATED [U.S. PHARMACEUTICALS]	1
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	XELJANZ (TOFACITINIB CITRATE) TABLET, FILM COATED [U.S. PHARMACEUTICALS]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63539-502	XELJANZ (TOFACITINIB) TABLET, FILM COATED XELJANZ XR (TOFACITINIB) TABLET, EXTENDED RELEASE [U.S. PHARMACEUTICALS]	13	Current NDC, Legacy NDC, 1 package rows	20250306_68e3d6b2-7838-4d2d-a417-09d919b43e13.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
O1FF4DIV0D	TOFACITINIB CITRATE	540737-29-9	TOFACITINIB CITRATE
87LA6FU830	TOFACITINIB	477600-75-2	tofacitinib

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2478433	tofacitinib 1 MG/mL Oral Solution	PSN	68e3d6b2-7838-4d2d-a417-09d919b43e13	17
2048566	tofacitinib 10 MG Oral Tablet	PSN	68e3d6b2-7838-4d2d-a417-09d919b43e13	17
1741046	tofacitinib 11 MG 24HR Extended Release Oral Tablet	PSN	68e3d6b2-7838-4d2d-a417-09d919b43e13	17
2273113	tofacitinib 22 MG 24HR Extended Release Oral Tablet	PSN	68e3d6b2-7838-4d2d-a417-09d919b43e13	17
1357541	tofacitinib 5 MG Oral Tablet	PSN	68e3d6b2-7838-4d2d-a417-09d919b43e13	17
2478437	Xeljanz 1 MG/mL Oral Solution	PSN	68e3d6b2-7838-4d2d-a417-09d919b43e13	17
2048568	Xeljanz 10 MG Oral Tablet	PSN	68e3d6b2-7838-4d2d-a417-09d919b43e13	17
1357547	Xeljanz 5 MG Oral Tablet	PSN	68e3d6b2-7838-4d2d-a417-09d919b43e13	17
1741049	Xeljanz XR 11 MG 24HR Extended Release Oral Tablet	PSN	68e3d6b2-7838-4d2d-a417-09d919b43e13	17
2273115	Xeljanz XR 22 MG 24HR Extended Release Oral Tablet	PSN	68e3d6b2-7838-4d2d-a417-09d919b43e13	17
1741049	24 HR tofacitinib 11 MG Extended Release Oral Tablet [Xeljanz]	SBD	68e3d6b2-7838-4d2d-a417-09d919b43e13	17
2273115	24 HR tofacitinib 22 MG Extended Release Oral Tablet [Xeljanz]	SBD	68e3d6b2-7838-4d2d-a417-09d919b43e13	17
2478437	tofacitinib 1 MG/ML Oral Solution [Xeljanz]	SBD	68e3d6b2-7838-4d2d-a417-09d919b43e13	17
2048568	tofacitinib 10 MG Oral Tablet [Xeljanz]	SBD	68e3d6b2-7838-4d2d-a417-09d919b43e13	17
1357547	tofacitinib 5 MG Oral Tablet [Xeljanz]	SBD	68e3d6b2-7838-4d2d-a417-09d919b43e13	17
1741046	24 HR tofacitinib 11 MG Extended Release Oral Tablet	SCD	68e3d6b2-7838-4d2d-a417-09d919b43e13	17
2273113	24 HR tofacitinib 22 MG Extended Release Oral Tablet	SCD	68e3d6b2-7838-4d2d-a417-09d919b43e13	17
2478433	tofacitinib 1 MG/ML Oral Solution	SCD	68e3d6b2-7838-4d2d-a417-09d919b43e13	17
2048566	tofacitinib 10 MG Oral Tablet	SCD	68e3d6b2-7838-4d2d-a417-09d919b43e13	17
1357541	tofacitinib 5 MG Oral Tablet	SCD	68e3d6b2-7838-4d2d-a417-09d919b43e13	17
2048566	tofacitinib 10 MG (as tofacitinib citrate 16 MG) Oral Tablet	SY	68e3d6b2-7838-4d2d-a417-09d919b43e13	17
1741046	tofacitinib 11 MG (as tofacitinib citrate 17.77 MG) 24 HR Extended Release Oral Tablet	SY	68e3d6b2-7838-4d2d-a417-09d919b43e13	17
1741046	tofacitinib 11 MG 24 HR Extended Release Oral Tablet	SY	68e3d6b2-7838-4d2d-a417-09d919b43e13	17
1357541	tofacitinib 5 MG (as tofacitinib citrate 8 MG) Oral Tablet	SY	68e3d6b2-7838-4d2d-a417-09d919b43e13	17
2478437	Xeljanz 1 MG/ML Oral Solution	SY	68e3d6b2-7838-4d2d-a417-09d919b43e13	17
2048568	Xeljanz 10 MG (as tofacitinib citrate 16 MG) Oral Tablet	SY	68e3d6b2-7838-4d2d-a417-09d919b43e13	17
2048568	Xeljanz 10 MG Oral Tablet	SY	68e3d6b2-7838-4d2d-a417-09d919b43e13	17
1357547	Xeljanz 5 MG (as tofacitinib citrate 8 MG) Oral Tablet	SY	68e3d6b2-7838-4d2d-a417-09d919b43e13	17
1357547	Xeljanz 5 MG Oral Tablet	SY	68e3d6b2-7838-4d2d-a417-09d919b43e13	17
1741049	Xeljanz XR 11 MG (as tofacitinib citrate 17.77 MG) 24 HR Extended Release Oral Tablet	SY	68e3d6b2-7838-4d2d-a417-09d919b43e13	17
1741049	Xeljanz XR 11 MG 24 HR Extended Release Oral Tablet	SY	68e3d6b2-7838-4d2d-a417-09d919b43e13	17
2273115	Xeljanz XR 22 MG (as tofacitinib citrate 35.54 MG) 24 HR Extended Release Oral Tablet	SY	68e3d6b2-7838-4d2d-a417-09d919b43e13	17

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
63539-502-30	63539050230	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (63539-502-30)	2020-01-21	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
XELJANZ	U.S. Pharmaceuticals \| Pfizer Inc \| Viatris Pharmaceuticals LLC \| Pfizer Ireland Pharmaceuticals Unlimited Company \| Pfizer Manufacturing Deutschland GmbH \| Pfizer Asia Manufacturing Pte Ltd \| Pharmacia & Upjohn Company LLC	2026-10-06	HUMAN PRESCRIPTION DRUG LABEL	19