TOFACITINIB tablets, for oral use

Manufacturer: Zydus Lifesciences Limited
Effective date: 2026-05-29
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 5
Source: daily-update
Hydrated at: 2026-06-11 05:10:41

Label at a glance#

Producttofacitinib

Active ingredientTOFACITINIB CITRATE

Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Tofacitinib Tablets, 5 mg

NDC 70771-1821-6

60 Tablets

Rx only

Tofacitinib Tablets, 10 mg

NDC 70771-1967-6

60 Tablets

Rx only

Product Linked Resources#

Resource, Code type, Value table
Resource	Code type	Value	Equivalent identifiers	Source image
Barcode	EAN-13	0370710158965	GTIN-13: 0370710158965 EAN-13: 0370710158965 GTIN-12: 370710158965 UPC-A: 370710158965 GTIN storage (14 digits): 00370710158965	c8e7d473-1e2e-4e6b-b1b9-a9f2a8706665-02.jpg

DailyMed Product Concepts#

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

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

tofacitinib
TOFACITINIB CITRATE
LACTOSE MONOHYDRATE
CELLULOSE, MICROCRYSTALLINE
CROSCARMELLOSE SODIUM
POVIDONE K30
MAGNESIUM STEARATE
HYPROMELLOSE 2910 (6 MPA.S)
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL 8000
FD&C BLUE NO. 1 ALUMINUM LAKE
FERRIC OXIDE YELLOW

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
70771-1821	70771-1821-6, 70771-1821-8
70771-1967	70771-1967-7, 70771-1967-6, 70771-1967-8

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
TOFACITINIB CITRATE	O1FF4DIV0D	ACTIM
LACTOSE MONOHYDRATE	EWQ57Q8I5X	IACT
CELLULOSE, MICROCRYSTALLINE	OP1R32D61U	IACT
CROSCARMELLOSE SODIUM	M28OL1HH48	IACT
POVIDONE K30	U725QWY32X	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
HYPROMELLOSE 2910 (6 MPA.S)	0WZ8WG20P6	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
POLYETHYLENE GLYCOL 8000	Q662QK8M3B	IACT
TOFACITINIB CITRATE	O1FF4DIV0D	ACTIM
LACTOSE MONOHYDRATE	EWQ57Q8I5X	IACT
CELLULOSE, MICROCRYSTALLINE	OP1R32D61U	IACT
CROSCARMELLOSE SODIUM	M28OL1HH48	IACT
POVIDONE K30	U725QWY32X	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
HYPROMELLOSE 2910 (6 MPA.S)	0WZ8WG20P6	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
POLYETHYLENE GLYCOL 8000	Q662QK8M3B	IACT
FD&C BLUE NO. 1 ALUMINUM LAKE	J9EQA3S2JM	IACT
FERRIC OXIDE YELLOW	EX438O2MRT	IACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
Version	Effective date	Source	Hydrated
4	2026-05-05	full-release	2026-05-31 22:18:46

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

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
A209829-001	TOFACITINIB CITRATE	TOFACITINIB CITRATE	EQ 5MG BASE	TABLET / ORAL	AB		2023-03-13
A209829-002	TOFACITINIB CITRATE	TOFACITINIB CITRATE	EQ 10MG BASE	TABLET / ORAL	AB		2026-06-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A209829-001	AB
A209829-002	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A209829-001	TOFACITINIB CITRATE	EQ 5MG BASE	TABLET / ORAL	AB	2023-03-13	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A209829-002	TOFACITINIB CITRATE	EQ 10MG BASE	TABLET / ORAL	AB	2026-06-05	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A209829-001	TOFACITINIB CITRATE	EQ 5MG BASE	TABLET / ORAL	AB	2023-03-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209829-002	TOFACITINIB CITRATE	EQ 10MG BASE	TABLET / ORAL	AB	2026-06-05	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A209829-001	TOFACITINIB CITRATE	EQ 5MG BASE	TABLET / ORAL	AB	2023-03-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209829-002	TOFACITINIB CITRATE	EQ 10MG BASE	TABLET / ORAL	AB	2026-06-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209829-001	TOFACITINIB CITRATE	EQ 5MG BASE	TABLET / ORAL		2023-03-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209829-001	TOFACITINIB CITRATE	EQ 5MG BASE	TABLET / ORAL		2023-03-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209829-001	TOFACITINIB CITRATE	EQ 5MG BASE	TABLET / ORAL		2023-03-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209829-001	TOFACITINIB CITRATE	EQ 5MG BASE	TABLET / ORAL		2023-03-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209829-001	TOFACITINIB CITRATE	EQ 5MG BASE	TABLET / ORAL		2023-03-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209829-001	TOFACITINIB CITRATE	EQ 5MG BASE	TABLET / ORAL		2023-03-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209829-001	TOFACITINIB CITRATE	EQ 5MG BASE	TABLET / ORAL		2023-03-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209829-001	TOFACITINIB CITRATE	EQ 5MG BASE	TABLET / ORAL		2023-03-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209829-001	TOFACITINIB CITRATE	EQ 5MG BASE	TABLET / ORAL		2023-03-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209829-001	TOFACITINIB CITRATE	EQ 5MG BASE	TABLET / ORAL		2023-03-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209829-001	TOFACITINIB CITRATE	EQ 5MG BASE	TABLET / ORAL		2023-03-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209829-001	TOFACITINIB CITRATE	EQ 5MG BASE	TABLET / ORAL		2023-03-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209829-001	TOFACITINIB CITRATE	EQ 5MG BASE	TABLET / ORAL		2023-03-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209829-001	TOFACITINIB CITRATE	EQ 5MG BASE	TABLET / ORAL		2023-03-13	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209829-001	TOFACITINIB CITRATE	EQ 5MG BASE	TABLET / ORAL		2023-03-13	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209829-001	TOFACITINIB CITRATE	EQ 5MG BASE	TABLET / ORAL		2023-03-13	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209829-001	TOFACITINIB CITRATE	EQ 5MG BASE	TABLET / ORAL		2023-03-13	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209829-001	TOFACITINIB CITRATE	EQ 5MG BASE	TABLET / ORAL		2023-03-13	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209829-001	TOFACITINIB CITRATE	EQ 5MG BASE	TABLET / ORAL		2023-03-13	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209829-001	TOFACITINIB CITRATE	EQ 5MG BASE	TABLET / ORAL	AB	2023-03-13	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209829-001	TOFACITINIB CITRATE	EQ 5MG BASE	TABLET / ORAL	AB	2023-03-13	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209829-001	TOFACITINIB CITRATE	EQ 5MG BASE	TABLET / ORAL	AB	2023-03-13	`053a50430f4f…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A209829-001	TOFACITINIB CITRATE	EQ 5MG BASE	TABLET / ORAL	AB	2023-03-13	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A209829-002	TOFACITINIB CITRATE	EQ 10MG BASE	TABLET / ORAL	AB	2026-06-05	`a50c72e98297…`

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	A209829-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A209829-002	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A209829-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209829-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A209829-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209829-002	AB	1	`caaa826d4ba7…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209829-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209829-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209829-001	AB	1	`053a50430f4f…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A209829-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A209829-002	AB	1	`a50c72e98297…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
tofacitinib	TOFACITINIB	Zydus Lifesciences Limited	f4d0e580-74a8-496e-89a2-d74478c946bf	2026-05-29		Exact identifier ndc (package): 70771-1967-7 ndc (package): 70771-1967-6 ndc (package): 70771-1821-6 ndc (package): 70771-1821-8 ndc (package): 70771-1967-8 ndc (product): 70771-1967 ndc (product): 70771-1821 ndc11 (package): 70771182108 ndc11 (package): 70771182106 ndc11 (package): 70771196707 ndc11 (package): 70771196708 ndc11 (package): 70771196706 spl id: c8e7d473-1e2e-4e6b-b1b9-a9f2a8706665 spl set id: f4d0e580-74a8-496e-89a2-d74478c946bf

Reported adverse events (FAERS/openFDA)#

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