tofacitinib

Product NDC: 70710-1727
11-digit product format: 707101727
Labeler code: 70710
Product ID: 70710-1727_ad974169-bcc9-4043-9ed1-201f13d8fd22
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: tofacitinib
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: Zydus Pharmaceuticals USA Inc.
Application: ANDA214264
Marketing category: ANDA
Marketing start: 2026-05-20
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

Observed NDC auxiliary status history#

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

Historic NDC status page 1 of 1 · 6 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	70710-1727-9	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	70710-1727-3	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	70710-1727-9	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	70710-1727-3	`f5e01cc5f278…`	`a2eaf40c39c3…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A214264-001	TOFACITINIB CITRATE	TOFACITINIB CITRATE	EQ 11MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB		2021-08-19
A214264-002	TOFACITINIB CITRATE	TOFACITINIB CITRATE	EQ 22MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB		2021-08-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A214264-001	AB
A214264-002	AB

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 · 68 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A214264-001	TOFACITINIB CITRATE	EQ 11MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2021-08-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214264-002	TOFACITINIB CITRATE	EQ 22MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2021-08-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214264-001	TOFACITINIB CITRATE	EQ 11MG BASE	TABLET, EXTENDED RELEASE / ORAL		2021-08-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214264-002	TOFACITINIB CITRATE	EQ 22MG BASE	TABLET, EXTENDED RELEASE / ORAL		2021-08-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214264-001	TOFACITINIB CITRATE	EQ 11MG BASE	TABLET, EXTENDED RELEASE / ORAL		2021-08-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214264-002	TOFACITINIB CITRATE	EQ 22MG BASE	TABLET, EXTENDED RELEASE / ORAL		2021-08-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214264-001	TOFACITINIB	EQ 11MG BASE	TABLET, EXTENDED RELEASE / ORAL		2021-08-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214264-002	TOFACITINIB	EQ 22MG BASE	TABLET, EXTENDED RELEASE / ORAL		2021-08-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214264-001	TOFACITINIB	EQ 11MG BASE	TABLET, EXTENDED RELEASE / ORAL		2021-08-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214264-002	TOFACITINIB	EQ 22MG BASE	TABLET, EXTENDED RELEASE / ORAL		2021-08-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214264-001	TOFACITINIB	EQ 11MG BASE	TABLET, EXTENDED RELEASE / ORAL		2021-08-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214264-002	TOFACITINIB	EQ 22MG BASE	TABLET, EXTENDED RELEASE / ORAL		2021-08-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214264-001	TOFACITINIB	EQ 11MG BASE	TABLET, EXTENDED RELEASE / ORAL		2021-08-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214264-002	TOFACITINIB	EQ 22MG BASE	TABLET, EXTENDED RELEASE / ORAL		2021-08-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214264-001	TOFACITINIB	EQ 11MG BASE	TABLET, EXTENDED RELEASE / ORAL		2021-08-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214264-002	TOFACITINIB	EQ 22MG BASE	TABLET, EXTENDED RELEASE / ORAL		2021-08-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214264-001	TOFACITINIB	EQ 11MG BASE	TABLET, EXTENDED RELEASE / ORAL		2021-08-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214264-002	TOFACITINIB	EQ 22MG BASE	TABLET, EXTENDED RELEASE / ORAL		2021-08-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214264-001	TOFACITINIB	EQ 11MG BASE	TABLET, EXTENDED RELEASE / ORAL		2021-08-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214264-002	TOFACITINIB	EQ 22MG BASE	TABLET, EXTENDED RELEASE / ORAL		2021-08-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214264-001	TOFACITINIB	EQ 11MG BASE	TABLET, EXTENDED RELEASE / ORAL		2021-08-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214264-002	TOFACITINIB	EQ 22MG BASE	TABLET, EXTENDED RELEASE / ORAL		2021-08-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214264-001	TOFACITINIB	EQ 11MG BASE	TABLET, EXTENDED RELEASE / ORAL		2021-08-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214264-002	TOFACITINIB	EQ 22MG BASE	TABLET, EXTENDED RELEASE / ORAL		2021-08-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214264-001	TOFACITINIB	EQ 11MG BASE	TABLET, EXTENDED RELEASE / ORAL		2021-08-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214264-002	TOFACITINIB	EQ 22MG BASE	TABLET, EXTENDED RELEASE / ORAL		2021-08-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214264-001	TOFACITINIB	EQ 11MG BASE	TABLET, EXTENDED RELEASE / ORAL		2021-08-19	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214264-002	TOFACITINIB	EQ 22MG BASE	TABLET, EXTENDED RELEASE / ORAL		2021-08-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214264-001	TOFACITINIB	EQ 11MG BASE	TABLET, EXTENDED RELEASE / ORAL		2021-08-19	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A214264-002	TOFACITINIB	EQ 22MG BASE	TABLET, EXTENDED RELEASE / ORAL		2021-08-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214264-001	TOFACITINIB	EQ 11MG BASE	TABLET, EXTENDED RELEASE / ORAL		2021-08-19	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214264-002	TOFACITINIB	EQ 22MG BASE	TABLET, EXTENDED RELEASE / ORAL		2021-08-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A214264-001	TOFACITINIB	EQ 11MG BASE	TABLET, EXTENDED RELEASE / ORAL		2021-08-19	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A214264-002	TOFACITINIB	EQ 22MG BASE	TABLET, EXTENDED RELEASE / ORAL		2021-08-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A214264-001	TOFACITINIB	EQ 11MG BASE	TABLET, EXTENDED RELEASE / ORAL		2021-08-19	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A214264-002	TOFACITINIB	EQ 22MG BASE	TABLET, EXTENDED RELEASE / ORAL		2021-08-19	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A214264-001	TOFACITINIB	EQ 11MG BASE	TABLET, EXTENDED RELEASE / ORAL		2021-08-19	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A214264-002	TOFACITINIB	EQ 22MG BASE	TABLET, EXTENDED RELEASE / ORAL		2021-08-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A214264-001	TOFACITINIB	EQ 11MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2021-08-19	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A214264-002	TOFACITINIB	EQ 22MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2021-08-19	`782e0a99824c…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A214264-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214264-002	AB	1	`caaa826d4ba7…`
2021-12-28 21:50 UTC	2021-12	A214264-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A214264-002	AB	1	`782e0a99824c…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214264-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214264-002	AB	1	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: tofacitinib
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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1741046	Internal RxNorm lookup
2273113	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
179ffbb2-bedc-40e6-b77b-33d4f7832172	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
70710-1727-3	tofacitinib	30 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	30		6
70710-1727-9	tofacitinib	90 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	90		6

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
tofacitinib	TOFACITINIB	Zydus Pharmaceuticals USA Inc.	179ffbb2-bedc-40e6-b77b-33d4f7832172	2026-08-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214264 application number: ANDA214264 ndc (product): 70710-1727
tofacitinib	TOFACITINIB	Zydus Lifesciences Limited	ac0b26d5-1352-42ff-b5ea-3eb02d8508a4	2026-05-12		Exact identifier application applno (ANDA): 214264 application number: ANDA214264

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

RxCUI, Display, Full name table
RxCUI	Display	Full name	Type	Form / route
1358492	tofacitinib citrate	tofacitinib citrate	PIN Active

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1741046	tofacitinib 11 MG 24HR Extended Release Oral Tablet	PSN	179ffbb2-bedc-40e6-b77b-33d4f7832172	6
2273113	tofacitinib 22 MG 24HR Extended Release Oral Tablet	PSN	179ffbb2-bedc-40e6-b77b-33d4f7832172	6
1741046	24 HR tofacitinib 11 MG Extended Release Oral Tablet	SCD	179ffbb2-bedc-40e6-b77b-33d4f7832172	6
2273113	24 HR tofacitinib 22 MG Extended Release Oral Tablet	SCD	179ffbb2-bedc-40e6-b77b-33d4f7832172	6
1741046	tofacitinib 11 MG (as tofacitinib citrate 17.77 MG) 24 HR Extended Release Oral Tablet	SY	179ffbb2-bedc-40e6-b77b-33d4f7832172	6
1741046	tofacitinib 11 MG 24 HR Extended Release Oral Tablet	SY	179ffbb2-bedc-40e6-b77b-33d4f7832172	6

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1741046	tofacitinib 11 MG 24HR Extended Release Oral Tablet	PSN	179ffbb2-bedc-40e6-b77b-33d4f7832172	6
2273113	tofacitinib 22 MG 24HR Extended Release Oral Tablet	PSN	179ffbb2-bedc-40e6-b77b-33d4f7832172	6
1741046	24 HR tofacitinib 11 MG Extended Release Oral Tablet	SCD	179ffbb2-bedc-40e6-b77b-33d4f7832172	6
2273113	24 HR tofacitinib 22 MG Extended Release Oral Tablet	SCD	179ffbb2-bedc-40e6-b77b-33d4f7832172	6
1741046	tofacitinib 11 MG (as tofacitinib citrate 17.77 MG) 24 HR Extended Release Oral Tablet	SY	179ffbb2-bedc-40e6-b77b-33d4f7832172	6
1741046	tofacitinib 11 MG 24 HR Extended Release Oral Tablet	SY	179ffbb2-bedc-40e6-b77b-33d4f7832172	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
70710-1727-3	70710172703	30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (70710-1727-3)	2026-05-20	No	No	Current
70710-1727-9	70710172709	90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (70710-1727-9)	2026-05-20	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
tofacitinib	Zydus Pharmaceuticals USA Inc. \| Zydus Lifesciences Limited	2026-08-07	HUMAN PRESCRIPTION DRUG LABEL	7

tofacitinib

Observed NDC auxiliary status history#

Orange Book products#

Therapeutic equivalence codes#

Observed Orange Book product history#

Observed Orange Book normalized TE history#

Additional Listing Data#

Active Ingredients#

Harmonized UNII identifiers#

Harmonized RxCUI identifiers#

Harmonized SPL set identifiers#

DailyMed Product Concepts#

DailyMed Package Descriptions#

openFDA label cross-check#

Related Records#

Related UNII Ingredients#

Related RxNorm Concepts#

DailyMed RxNorm Mappings#

DailyMed RxNorm Mappings#

Packages#

Related DailyMed Labels#