XELJANZ

Product NDC: 63539-502
11-digit product format: 635390502
Labeler code: 63539
Product ID: 63539-502_184c6caf-b874-4b42-9a0d-30219f3fd2ef
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 1.

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 2 · 78 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	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…`
2019-12-13 00:20 UTC	2019-12	N208246-001	XELJANZ XR	EQ 11MG BASE	TABLET, EXTENDED RELEASE / ORAL		RLD, RS	2016-02-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N208246-001	XELJANZ XR	EQ 11MG BASE	TABLET, EXTENDED RELEASE / ORAL		RLD	2016-02-23	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N208246-002	XELJANZ XR	EQ 22MG BASE	TABLET, EXTENDED RELEASE / ORAL		RLD, RS	2019-12-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N208246-001	XELJANZ XR	EQ 11MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2016-02-23	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N208246-002	XELJANZ XR	EQ 22MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2019-12-12	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208246-001	XELJANZ XR	EQ 11MG BASE	TABLET, EXTENDED RELEASE / ORAL		RLD	2016-02-23	`87673890dc5c…`

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	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 13 · 504 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	N208246-001	RE41783	2025-12-08		Drug substance	2016-03-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208246-001	RE41783*PED	2026-06-08		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208246-001	11253523	2034-03-14	U-3326		2022-03-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208246-001	11253523	2034-03-14	U-3327		2022-03-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208246-001	11253523	2034-03-14	U-3328		2022-03-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208246-001	11253523	2034-03-14	U-3329		2022-03-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208246-001	9937181	2034-03-14		Drug product	2018-05-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208246-001	11253523*PED	2034-09-14		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208246-001	9937181*PED	2034-09-14		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208246-002	RE41783	2025-12-08		Drug substance	2020-01-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208246-002	RE41783*PED	2026-06-08		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208246-002	10639309	2034-03-14		Drug product	2020-06-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208246-002	11253523	2034-03-14	U-3326		2022-03-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208246-002	11253523	2034-03-14	U-3327		2022-03-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208246-002	11253523	2034-03-14	U-3328		2022-03-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208246-002	11253523	2034-03-14	U-3329		2022-03-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208246-002	10639309*PED	2034-09-14		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208246-002	11253523*PED	2034-09-14		Pediatric extension		`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208246-001	RE41783	2025-12-08		Drug substance	2016-03-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208246-001	RE41783*PED	2026-06-08		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208246-001	11253523	2034-03-14	U-3326		2022-03-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208246-001	11253523	2034-03-14	U-3327		2022-03-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208246-001	11253523	2034-03-14	U-3328		2022-03-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208246-001	11253523	2034-03-14	U-3329		2022-03-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208246-001	9937181	2034-03-14		Drug product	2018-05-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208246-001	11253523*PED	2034-09-14		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208246-001	9937181*PED	2034-09-14		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208246-002	RE41783	2025-12-08		Drug substance	2020-01-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208246-002	RE41783*PED	2026-06-08		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208246-002	10639309	2034-03-14		Drug product	2020-06-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208246-002	11253523	2034-03-14	U-3326		2022-03-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208246-002	11253523	2034-03-14	U-3327		2022-03-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208246-002	11253523	2034-03-14	U-3328		2022-03-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208246-002	11253523	2034-03-14	U-3329		2022-03-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208246-002	10639309*PED	2034-09-14		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208246-002	11253523*PED	2034-09-14		Pediatric extension		`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208246-001	RE41783	2025-12-08		Drug substance	2016-03-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208246-001	RE41783*PED	2026-06-08		Pediatric extension		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208246-001	11253523	2034-03-14	U-3326		2022-03-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208246-001	11253523	2034-03-14	U-3327		2022-03-23	`6a471c1ec25d…`

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…`

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
O1FF4DIV0D	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 10 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1357541	Internal RxNorm lookup
1357547	Internal RxNorm lookup
1741046	Internal RxNorm lookup
1741049	Internal RxNorm lookup
2048566	Internal RxNorm lookup
2048568	Internal RxNorm lookup
2273113	Internal RxNorm lookup
2273115	Internal RxNorm lookup
2478433	Internal RxNorm lookup
2478437	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
68e3d6b2-7838-4d2d-a417-09d919b43e13	Available on FDA.report

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
2021-07-23	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

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

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
XELJANZ	TOFACITINIB	U.S. Pharmaceuticals	68e3d6b2-7838-4d2d-a417-09d919b43e13	2026-07-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 208246 application number: NDA208246 ndc (product): 63539-502
XELJANZ XR	TOFACITINIB	Pfizer Laboratories Div Pfizer Inc	cf74ba2f-afc5-4baa-8594-979c889a5831	2026-07-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 208246 application number: NDA208246

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	2026-07-13	HUMAN PRESCRIPTION DRUG LABEL	18