XELJANZ

Product NDC: 0069-1029
11-digit product format: 000691029
Labeler code: 0069
Product ID: 0069-1029_39aa36a4-7b51-43af-9bf0-d812b3f9bd1d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: tofacitinib
Dosage form: SOLUTION
Route: ORAL
Labeler: Pfizer Laboratories Div Pfizer Inc
Application: NDA213082
Marketing category: NDA
Marketing start: 2021-02-08
Substance: TOFACITINIB CITRATE
Active strength: 1 mg/mL
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N213082-001	XELJANZ	TOFACITINIB CITRATE	EQ 1MG BASE/ML	SOLUTION / ORAL	AA	RLD, RS	2020-09-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N213082-001	AA

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N213082-001	RE41783	2025-12-08		Drug substance	2020-10-22
N213082-001	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
N213082-001	M-14	2028-02-21
N213082-001	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.

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	N213082-001	XELJANZ	EQ 1MG BASE/ML	SOLUTION / ORAL		RLD, RS	2020-09-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213082-001	XELJANZ	EQ 1MG BASE/ML	SOLUTION / ORAL		RLD, RS	2020-09-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N213082-001	XELJANZ	EQ 1MG BASE/ML	SOLUTION / ORAL		RLD, RS	2020-09-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213082-001	XELJANZ	EQ 1MG BASE/ML	SOLUTION / ORAL		RLD, RS	2020-09-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213082-001	XELJANZ	EQ 1MG BASE/ML	SOLUTION / ORAL		RLD, RS	2020-09-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213082-001	XELJANZ	EQ 1MG BASE/ML	SOLUTION / ORAL		RLD, RS	2020-09-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213082-001	XELJANZ	EQ 1MG BASE/ML	SOLUTION / ORAL		RLD, RS	2020-09-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213082-001	XELJANZ	EQ 1MG BASE/ML	SOLUTION / ORAL	AA	RLD, RS	2020-09-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213082-001	XELJANZ	EQ 1MG BASE/ML	SOLUTION / ORAL		RLD, RS	2020-09-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N213082-001	XELJANZ	EQ 1MG BASE/ML	SOLUTION / ORAL	AA	RLD, RS	2020-09-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N213082-001	XELJANZ	EQ 1MG BASE/ML	SOLUTION / ORAL	AA	RLD, RS	2020-09-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N213082-001	XELJANZ	EQ 1MG BASE/ML	SOLUTION / ORAL	AA	RLD, RS	2020-09-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N213082-001	XELJANZ	EQ 1MG BASE/ML	SOLUTION / ORAL	AA	RLD, RS	2020-09-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N213082-001	XELJANZ	EQ 1MG BASE/ML	SOLUTION / ORAL	AA	RLD, RS	2020-09-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N213082-001	XELJANZ	EQ 1MG/ML BASE	SOLUTION / ORAL		RLD, RS	2020-09-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N213082-001	XELJANZ	EQ 1MG/ML BASE	SOLUTION / ORAL		RLD, RS	2020-09-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N213082-001	XELJANZ	EQ 1MG/ML BASE	SOLUTION / ORAL		RLD, RS	2020-09-25	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N213082-001	XELJANZ	EQ 1MG/ML BASE	SOLUTION / ORAL		RLD, RS	2020-09-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N213082-001	XELJANZ	EQ 1MG/ML BASE	SOLUTION / ORAL		RLD, RS	2020-09-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N213082-001	XELJANZ	EQ 1MG/ML BASE	SOLUTION / ORAL		RLD, RS	2020-09-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N213082-001	Xeljanz	EQ 1MG/ML BASE	SOLUTION / ORAL		RLD, RS	2020-09-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N213082-001	Xeljanz	EQ 1MG/ML BASE	SOLUTION / ORAL		RLD, RS	2020-09-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N213082-001	Xeljanz	EQ 1MG/ML BASE	SOLUTION / ORAL		RLD, RS	2020-09-25	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N213082-001	XELJANZ	EQ 1MG BASE/ML	SOLUTION / ORAL	AA	RLD, RS	2020-09-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N213082-001	XELJANZ	EQ 1MG BASE/ML	SOLUTION / ORAL	AA	RLD, RS	2020-09-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N213082-001	XELJANZ	EQ 1MG BASE/ML	SOLUTION / ORAL	AA	RLD, RS	2020-09-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N213082-001	XELJANZ	EQ 1MG BASE/ML	SOLUTION / ORAL	AA	RLD, RS	2020-09-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N213082-001	XELJANZ	EQ 1MG BASE/ML	SOLUTION / ORAL	AA	RLD, RS	2020-09-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N213082-001	XELJANZ	EQ 1MG/ML BASE	SOLUTION / ORAL		RLD, RS	2020-09-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N213082-001	XELJANZ	EQ 1MG/ML BASE	SOLUTION / ORAL		RLD, RS	2020-09-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N213082-001	XELJANZ	EQ 1MG/ML BASE	SOLUTION / ORAL		RLD, RS	2020-09-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N213082-001	XELJANZ	EQ 1MG/ML BASE	SOLUTION / ORAL		RLD, RS	2020-09-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N213082-001	XELJANZ	EQ 1MG/ML BASE	SOLUTION / ORAL		RLD, RS	2020-09-25	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N213082-001	XELJANZ	EQ 1MG/ML BASE	SOLUTION / ORAL		RLD, RS	2020-09-25	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N213082-001	XELJANZ	EQ 1MG/ML BASE	SOLUTION / ORAL		RLD, RS	2020-09-25	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N213082-001	XELJANZ	EQ 1MG/ML BASE	SOLUTION / ORAL		RLD, RS	2020-09-25	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N213082-001	XELJANZ	EQ 1MG BASE/ML	SOLUTION / ORAL	AA	RLD, RS	2020-09-25	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213082-001	AA	1	`5bbf6a4d5a75…`
2024-10-29 15:01 UTC	2024-10	N213082-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N213082-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N213082-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N213082-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N213082-001	AA	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N213082-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N213082-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N213082-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N213082-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N213082-001	AA	1	`9b2671bbb829…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N213082-001	AA	1	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 48 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N213082-001	RE41783	2025-12-08	Drug substance	2020-10-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213082-001	RE41783*PED	2026-06-08	Pediatric extension		`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213082-001	RE41783	2025-12-08	Drug substance	2020-10-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213082-001	RE41783*PED	2026-06-08	Pediatric extension		`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N213082-001	RE41783	2025-12-08	Drug substance	2020-10-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213082-001	RE41783*PED	2026-06-08	Pediatric extension		`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213082-001	RE41783	2025-12-08	Drug substance	2020-10-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213082-001	RE41783*PED	2026-06-08	Pediatric extension		`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213082-001	RE41783	2025-12-08	Drug substance	2020-10-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213082-001	RE41783	2025-12-08	Drug substance	2020-10-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213082-001	RE41783	2025-12-08	Drug substance	2020-10-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213082-001	RE41783	2025-12-08	Drug substance	2020-10-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213082-001	RE41783	2025-12-08	Drug substance	2020-10-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N213082-001	RE41783	2025-12-08	Drug substance	2020-10-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N213082-001	RE41783	2025-12-08	Drug substance	2020-10-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N213082-001	RE41783	2025-12-08	Drug substance	2020-10-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N213082-001	RE41783	2025-12-08	Drug substance	2020-10-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N213082-001	RE41783	2025-12-08	Drug substance	2020-10-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N213082-001	RE41783	2025-12-08	Drug substance	2020-10-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N213082-001	RE41783	2025-12-08	Drug substance	2020-10-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N213082-001	RE41783	2025-12-08	Drug substance	2020-10-22	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N213082-001	RE41783	2025-12-08	Drug substance	2020-10-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N213082-001	RE41783	2025-12-08	Drug substance	2020-10-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N213082-001	RE41783	2025-12-08	Drug substance	2020-10-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N213082-001	RE41783	2025-12-08	Drug substance	2020-10-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N213082-001	6956041	2020-12-08	Drug product	2020-10-22	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N213082-001	7265221	2020-12-08	Drug substance	2020-10-22	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N213082-001	7301023	2020-12-08	Drug substance	2020-10-22	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N213082-001	RE41783	2025-12-08	Drug substance	2020-10-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N213082-001	6956041	2020-12-08	Drug product	2020-10-22	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N213082-001	7265221	2020-12-08	Drug substance	2020-10-22	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N213082-001	7301023	2020-12-08	Drug substance	2020-10-22	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N213082-001	RE41783	2025-12-08	Drug substance	2020-10-22	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N213082-001	RE41783	2025-12-08	Drug substance	2020-10-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N213082-001	RE41783	2025-12-08	Drug substance	2020-10-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N213082-001	RE41783	2025-12-08	Drug substance	2020-10-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N213082-001	RE41783	2025-12-08	Drug substance	2020-10-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N213082-001	RE41783	2025-12-08	Drug substance	2020-10-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N213082-001	RE41783	2025-12-08	Drug substance	2020-10-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N213082-001	RE41783	2025-12-08	Drug substance	2020-10-22	`3f0d92c62455…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N213082-001	M-14	2028-02-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213082-001	PED	2028-08-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213082-001	M-14	2028-02-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213082-001	PED	2028-08-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N213082-001	M-14	2028-02-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213082-001	PED	2028-08-21	`6a471c1ec25d…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N213082-001	NP	2023-09-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N213082-001	NP	2023-09-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N213082-001	NP	2023-09-25	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N213082-001	NP	2023-09-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N213082-001	NP	2023-09-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N213082-001	NP	2023-09-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N213082-001	NP	2023-09-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N213082-001	NP	2023-09-25	`8869cabd3fbd…`
2023-12-20 04:57 UTC	2023-12	N213082-001	NP	2023-09-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N213082-001	NP	2023-09-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N213082-001	NP	2023-09-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N213082-001	NP	2023-09-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N213082-001	NP	2023-09-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N213082-001	NP	2023-09-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N213082-001	NP	2023-09-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N213082-001	NP	2023-09-25	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N213082-001	NP	2023-09-25	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N213082-001	NP	2023-09-25	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N213082-001	NP	2023-09-25	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N213082-001	M-14	2028-02-21	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N213082-001	PED	2028-08-21	`a50c72e98297…`

Additional Listing Data#

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

Active Ingredients#

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

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
cf74ba2f-afc5-4baa-8594-979c889a5831	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0069-1029-01	XELJANZ	240 mL in 1 BOTTLE	SOLUTION	240		53
0069-1029-02	XELJANZ	1 in 1 CARTON	SOLUTION	1		53

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0069-1029-01	ML - Milliliter	0069-1029	e8f5459b-9e04-49e2-9207-b8563b645f0a	1	2021-03-02
0069-1029-02	ML - Milliliter	0069-1029	ab3afb2e-c7a8-4c8c-b7d7-2c29d2947f52	1	2021-03-02

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
0069-1029	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, 2 package rows	20241222_cf74ba2f-afc5-4baa-8594-979c889a5831.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): 213082 application number: NDA213082
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): 213082 application number: NDA213082 ndc (product): 0069-1029

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	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0069-1029-01	00069102901	240 mL in 1 BOTTLE	240 ml					Historical
0069-1029-02	00069102902	1 BOTTLE in 1 CARTON (0069-1029-02) / 240 mL in 1 BOTTLE (0069-1029-01)	1 bottle	2021-02-08	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	2026-07-12	HUMAN PRESCRIPTION DRUG LABEL	54