XELJANZ

Product NDC: 0069-1002
11-digit product format: 000691002
Labeler code: 0069
Product ID: 0069-1002_23ff09f3-4af4-4232-a8b3-d84f8f16fb9c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: tofacitinib
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Pfizer Laboratories Div Pfizer Inc
Application: NDA203214
Marketing category: NDA
Marketing start: 2018-07-02
Substance: TOFACITINIB CITRATE
Active strength: 10 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
N203214-001	XELJANZ	TOFACITINIB CITRATE	EQ 5MG BASE	TABLET / ORAL	AB	RLD	2012-11-06
N203214-002	XELJANZ	TOFACITINIB CITRATE	EQ 10MG BASE	TABLET / ORAL	AB	RLD, RS	2018-05-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N203214-001	AB
N203214-002	AB

Orange Book patents#

Current patent rows page 1 of 1 · 4 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Coverage / status	Submission date
N203214-001	RE41783	2025-12-08	Drug substance	2012-11-30
N203214-001	RE41783*PED	2026-06-08	Pediatric extension
N203214-002	RE41783	2025-12-08	Drug substance	2018-06-28
N203214-002	RE41783*PED	2026-06-08	Pediatric extension

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N203214-001	M-14	2028-02-21
N203214-001	PED	2028-08-21

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 · 88 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	N203214-001	XELJANZ	EQ 5MG BASE	TABLET / ORAL	AB	RLD	2012-11-06	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N203214-002	XELJANZ	EQ 10MG BASE	TABLET / ORAL	AB	RLD, RS	2018-05-30	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N203214-001	XELJANZ	EQ 5MG BASE	TABLET / ORAL	AB	RLD	2012-11-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203214-002	XELJANZ	EQ 10MG BASE	TABLET / ORAL	AB	RLD, RS	2018-05-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N203214-001	XELJANZ	EQ 5MG BASE	TABLET / ORAL	AB	RLD	2012-11-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203214-002	XELJANZ	EQ 10MG BASE	TABLET / ORAL	AB	RLD, RS	2018-05-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N203214-001	XELJANZ	EQ 5MG BASE	TABLET / ORAL		RLD	2012-11-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203214-002	XELJANZ	EQ 10MG BASE	TABLET / ORAL		RLD, RS	2018-05-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203214-001	XELJANZ	EQ 5MG BASE	TABLET / ORAL		RLD	2012-11-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203214-002	XELJANZ	EQ 10MG BASE	TABLET / ORAL		RLD, RS	2018-05-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N203214-001	XELJANZ	EQ 5MG BASE	TABLET / ORAL		RLD	2012-11-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203214-002	XELJANZ	EQ 10MG BASE	TABLET / ORAL		RLD, RS	2018-05-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203214-001	XELJANZ	EQ 5MG BASE	TABLET / ORAL		RLD	2012-11-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203214-002	XELJANZ	EQ 10MG BASE	TABLET / ORAL		RLD, RS	2018-05-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203214-001	XELJANZ	EQ 5MG BASE	TABLET / ORAL		RLD	2012-11-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203214-002	XELJANZ	EQ 10MG BASE	TABLET / ORAL		RLD, RS	2018-05-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203214-001	XELJANZ	EQ 5MG BASE	TABLET / ORAL		RLD	2012-11-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203214-002	XELJANZ	EQ 10MG BASE	TABLET / ORAL		RLD, RS	2018-05-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203214-001	XELJANZ	EQ 5MG BASE	TABLET / ORAL		RLD	2012-11-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203214-002	XELJANZ	EQ 10MG BASE	TABLET / ORAL		RLD, RS	2018-05-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203214-001	XELJANZ	EQ 5MG BASE	TABLET / ORAL		RLD	2012-11-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203214-002	XELJANZ	EQ 10MG BASE	TABLET / ORAL		RLD, RS	2018-05-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203214-001	XELJANZ	EQ 5MG BASE	TABLET / ORAL		RLD	2012-11-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203214-002	XELJANZ	EQ 10MG BASE	TABLET / ORAL		RLD, RS	2018-05-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N203214-001	XELJANZ	EQ 5MG BASE	TABLET / ORAL		RLD	2012-11-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N203214-002	XELJANZ	EQ 10MG BASE	TABLET / ORAL		RLD, RS	2018-05-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N203214-001	XELJANZ	EQ 5MG BASE	TABLET / ORAL		RLD	2012-11-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N203214-002	XELJANZ	EQ 10MG BASE	TABLET / ORAL		RLD, RS	2018-05-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N203214-001	XELJANZ	EQ 5MG BASE	TABLET / ORAL		RLD	2012-11-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N203214-002	XELJANZ	EQ 10MG BASE	TABLET / ORAL		RLD, RS	2018-05-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N203214-001	XELJANZ	EQ 5MG BASE	TABLET / ORAL		RLD	2012-11-06	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N203214-002	XELJANZ	EQ 10MG BASE	TABLET / ORAL		RLD, RS	2018-05-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N203214-001	XELJANZ	EQ 5MG BASE	TABLET / ORAL		RLD	2012-11-06	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N203214-002	XELJANZ	EQ 10MG BASE	TABLET / ORAL		RLD, RS	2018-05-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N203214-001	XELJANZ	EQ 5MG BASE	TABLET / ORAL		RLD	2012-11-06	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N203214-002	XELJANZ	EQ 10MG BASE	TABLET / ORAL		RLD, RS	2018-05-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N203214-001	XELJANZ	EQ 5MG BASE	TABLET / ORAL		RLD	2012-11-06	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N203214-002	XELJANZ	EQ 10MG BASE	TABLET / ORAL		RLD, RS	2018-05-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N203214-001	XELJANZ	EQ 5MG BASE	TABLET / ORAL		RLD	2012-11-06	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N203214-002	XELJANZ	EQ 10MG BASE	TABLET / ORAL		RLD, RS	2018-05-30	`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	N203214-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N203214-002	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N203214-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203214-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N203214-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203214-002	AB	1	`caaa826d4ba7…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N203214-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N203214-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N203214-001	AB	1	`053a50430f4f…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N203214-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N203214-002	AB	1	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 6 · 206 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-10-15 13:18:30	2026-09	N203214-001	RE41783	2025-12-08	Drug substance	2012-11-30	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N203214-001	RE41783*PED	2026-06-08	Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N203214-002	RE41783	2025-12-08	Drug substance	2018-06-28	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N203214-002	RE41783*PED	2026-06-08	Pediatric extension		`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N203214-001	RE41783	2025-12-08	Drug substance	2012-11-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203214-001	RE41783*PED	2026-06-08	Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203214-002	RE41783	2025-12-08	Drug substance	2018-06-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203214-002	RE41783*PED	2026-06-08	Pediatric extension		`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N203214-001	RE41783	2025-12-08	Drug substance	2012-11-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203214-001	RE41783*PED	2026-06-08	Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203214-002	RE41783	2025-12-08	Drug substance	2018-06-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203214-002	RE41783*PED	2026-06-08	Pediatric extension		`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N203214-001	RE41783	2025-12-08	Drug substance	2012-11-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203214-001	RE41783*PED	2026-06-08	Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203214-002	RE41783	2025-12-08	Drug substance	2018-06-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203214-002	RE41783*PED	2026-06-08	Pediatric extension		`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203214-001	RE41783	2025-12-08	Drug substance	2012-11-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203214-001	RE41783*PED	2026-06-08	Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203214-002	RE41783	2025-12-08	Drug substance	2018-06-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203214-002	RE41783*PED	2026-06-08	Pediatric extension		`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N203214-001	RE41783	2025-12-08	Drug substance	2012-11-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203214-001	RE41783*PED	2026-06-08	Pediatric extension		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203214-002	RE41783	2025-12-08	Drug substance	2018-06-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203214-002	RE41783*PED	2026-06-08	Pediatric extension		`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203214-001	RE41783	2025-12-08	Drug substance	2012-11-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203214-001	RE41783*PED	2026-06-08	Pediatric extension		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203214-002	RE41783	2025-12-08	Drug substance	2018-06-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203214-002	RE41783*PED	2026-06-08	Pediatric extension		`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203214-001	RE41783	2025-12-08	Drug substance	2012-11-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203214-002	RE41783	2025-12-08	Drug substance	2018-06-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203214-001	RE41783	2025-12-08	Drug substance	2012-11-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203214-002	RE41783	2025-12-08	Drug substance	2018-06-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203214-001	RE41783	2025-12-08	Drug substance	2012-11-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203214-002	RE41783	2025-12-08	Drug substance	2018-06-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203214-001	RE41783	2025-12-08	Drug substance	2012-11-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203214-002	RE41783	2025-12-08	Drug substance	2018-06-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203214-001	RE41783	2025-12-08	Drug substance	2012-11-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203214-002	RE41783	2025-12-08	Drug substance	2018-06-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N203214-001	RE41783	2025-12-08	Drug substance	2012-11-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N203214-002	RE41783	2025-12-08	Drug substance	2018-06-28	`d06236e962d9…`

Observed Orange Book exclusivity history#

Exclusivity history page 3 of 3 · 109 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N203214-001	NPP	2023-09-25	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N203214-001	I-879	2024-12-14	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N203214-002	I-879	2024-12-14	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N203214-001	NPP	2023-09-25	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N203214-001	I-879	2024-12-14	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N203214-002	I-879	2024-12-14	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N203214-001	NPP	2023-09-25	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N203214-001	I-879	2024-12-14	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N203214-002	I-879	2024-12-14	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N203214-001	NPP	2023-09-25	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N203214-001	I-879	2024-12-14	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N203214-002	I-879	2024-12-14	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N203214-001	NPP	2023-09-25	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N203214-001	I-879	2024-12-14	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N203214-002	I-879	2024-12-14	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N203214-001	NPP	2023-09-25	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N203214-001	I-879	2024-12-14	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N203214-002	I-879	2024-12-14	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N203214-001	NPP	2023-09-25	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N203214-001	I-879	2024-12-14	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N203214-002	I-879	2024-12-14	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N203214-001	NPP	2023-09-25	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N203214-001	I-879	2024-12-14	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N203214-002	I-879	2024-12-14	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N203214-001	NPP	2023-09-25	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N203214-001	I-879	2024-12-14	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N203214-002	I-879	2024-12-14	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N203214-001	M-14	2028-02-21	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N203214-001	PED	2028-08-21	`a50c72e98297…`

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
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TOFACITINIB CITRATE	10 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0069-1002-01	XELJANZ	60 in 1 BOTTLE	TABLET, FILM COATED	60		53

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0069-1002-01	EA - Each	0069-1002	a24cf820-06d7-4e3d-a7ee-a1d88526cb53	1	2018-07-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
TOFACITINIB CITRATE	ACTIVE INGREDIENT	O1FF4DIV0D	XELJANZ (TOFACITINIB) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC]	12
TOFACITINIB	ACTIVE MOIETY	87LA6FU830	XELJANZ (TOFACITINIB) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC]	12
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	XELJANZ (TOFACITINIB) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC]	12
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	XELJANZ (TOFACITINIB) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC]	12
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	XELJANZ (TOFACITINIB) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC]	12
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	XELJANZ (TOFACITINIB) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC]	12
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	XELJANZ (TOFACITINIB) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC]	12
POLYETHYLENE GLYCOL 3350	INACTIVE INGREDIENT	G2M7P15E5P	XELJANZ (TOFACITINIB) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC]	12
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	XELJANZ (TOFACITINIB) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC]	12
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	XELJANZ (TOFACITINIB) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC]	12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0069-1002	XELJANZ (TOFACITINIB) TABLET, FILM COATED XELJANZ XR (TOFACITINIB) TABLET, FILM COATED, EXTENDED RELEASE XELJANZ (TOFACITINIB) SOLUTION [PFIZER LABORATORIES DIV PFIZER INC]	49	Current NDC, Legacy NDC, 1 package rows	20241222_cf74ba2f-afc5-4baa-8594-979c889a5831.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	cf74ba2f-afc5-4baa-8594-979c889a5831	53
2048566	tofacitinib 10 MG Oral Tablet	PSN	cf74ba2f-afc5-4baa-8594-979c889a5831	53
1741046	tofacitinib 11 MG 24HR Extended Release Oral Tablet	PSN	cf74ba2f-afc5-4baa-8594-979c889a5831	53
2273113	tofacitinib 22 MG 24HR Extended Release Oral Tablet	PSN	cf74ba2f-afc5-4baa-8594-979c889a5831	53
1357541	tofacitinib 5 MG Oral Tablet	PSN	cf74ba2f-afc5-4baa-8594-979c889a5831	53
2478437	Xeljanz 1 MG/mL Oral Solution	PSN	cf74ba2f-afc5-4baa-8594-979c889a5831	53
2048568	Xeljanz 10 MG Oral Tablet	PSN	cf74ba2f-afc5-4baa-8594-979c889a5831	53
1357547	Xeljanz 5 MG Oral Tablet	PSN	cf74ba2f-afc5-4baa-8594-979c889a5831	53
1741049	Xeljanz XR 11 MG 24HR Extended Release Oral Tablet	PSN	cf74ba2f-afc5-4baa-8594-979c889a5831	53
2273115	Xeljanz XR 22 MG 24HR Extended Release Oral Tablet	PSN	cf74ba2f-afc5-4baa-8594-979c889a5831	53
1741049	24 HR tofacitinib 11 MG Extended Release Oral Tablet [Xeljanz]	SBD	cf74ba2f-afc5-4baa-8594-979c889a5831	53
2273115	24 HR tofacitinib 22 MG Extended Release Oral Tablet [Xeljanz]	SBD	cf74ba2f-afc5-4baa-8594-979c889a5831	53
2478437	tofacitinib 1 MG/ML Oral Solution [Xeljanz]	SBD	cf74ba2f-afc5-4baa-8594-979c889a5831	53
2048568	tofacitinib 10 MG Oral Tablet [Xeljanz]	SBD	cf74ba2f-afc5-4baa-8594-979c889a5831	53
1357547	tofacitinib 5 MG Oral Tablet [Xeljanz]	SBD	cf74ba2f-afc5-4baa-8594-979c889a5831	53
1741046	24 HR tofacitinib 11 MG Extended Release Oral Tablet	SCD	cf74ba2f-afc5-4baa-8594-979c889a5831	53
2273113	24 HR tofacitinib 22 MG Extended Release Oral Tablet	SCD	cf74ba2f-afc5-4baa-8594-979c889a5831	53
2478433	tofacitinib 1 MG/ML Oral Solution	SCD	cf74ba2f-afc5-4baa-8594-979c889a5831	53
2048566	tofacitinib 10 MG Oral Tablet	SCD	cf74ba2f-afc5-4baa-8594-979c889a5831	53
1357541	tofacitinib 5 MG Oral Tablet	SCD	cf74ba2f-afc5-4baa-8594-979c889a5831	53
2048566	tofacitinib 10 MG (as tofacitinib citrate 16 MG) Oral Tablet	SY	cf74ba2f-afc5-4baa-8594-979c889a5831	53
1741046	tofacitinib 11 MG (as tofacitinib citrate 17.77 MG) 24 HR Extended Release Oral Tablet	SY	cf74ba2f-afc5-4baa-8594-979c889a5831	53
1741046	tofacitinib 11 MG 24 HR Extended Release Oral Tablet	SY	cf74ba2f-afc5-4baa-8594-979c889a5831	53
1357541	tofacitinib 5 MG (as tofacitinib citrate 8 MG) Oral Tablet	SY	cf74ba2f-afc5-4baa-8594-979c889a5831	53
2478437	Xeljanz 1 MG/ML Oral Solution	SY	cf74ba2f-afc5-4baa-8594-979c889a5831	53
2048568	Xeljanz 10 MG (as tofacitinib citrate 16 MG) Oral Tablet	SY	cf74ba2f-afc5-4baa-8594-979c889a5831	53
2048568	Xeljanz 10 MG Oral Tablet	SY	cf74ba2f-afc5-4baa-8594-979c889a5831	53
1357547	Xeljanz 5 MG (as tofacitinib citrate 8 MG) Oral Tablet	SY	cf74ba2f-afc5-4baa-8594-979c889a5831	53
1357547	Xeljanz 5 MG Oral Tablet	SY	cf74ba2f-afc5-4baa-8594-979c889a5831	53
1741049	Xeljanz XR 11 MG (as tofacitinib citrate 17.77 MG) 24 HR Extended Release Oral Tablet	SY	cf74ba2f-afc5-4baa-8594-979c889a5831	53
1741049	Xeljanz XR 11 MG 24 HR Extended Release Oral Tablet	SY	cf74ba2f-afc5-4baa-8594-979c889a5831	53
2273115	Xeljanz XR 22 MG (as tofacitinib citrate 35.54 MG) 24 HR Extended Release Oral Tablet	SY	cf74ba2f-afc5-4baa-8594-979c889a5831	53

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0069-1002-01	00069100201	60 TABLET, FILM COATED in 1 BOTTLE (0069-1002-01)	2018-07-02	0000-00-00	No	No	Current
0069-1002-02	00069100202	180 TABLET, FILM COATED in 1 BOTTLE (0069-1002-02)	2018-07-02	0000-00-00	No	No	Current
0069-1002-03	00069100203	28 TABLET, FILM COATED in 1 BOTTLE (0069-1002-03)	2018-07-02	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
XELJANZ	Pfizer Laboratories Div Pfizer Inc \| Viatris Pharmaceuticals LLC \| Pfizer Ireland Pharmaceuticals Unlimited Company \| Pfizer Manufacturing Deutschland GmbH \| Pharmacia & Upjohn Company LLC \| Pfizer Asia Manufacturing Pte Ltd	2026-09-25	HUMAN PRESCRIPTION DRUG LABEL	55