TOFACITINIB Extended-Release Tablets

Manufacturer
Zydus Lifesciences Limited
Effective date
2026-05-12
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-05-31 22:20:28

Label at a glance#

Producttofacitinib
Active ingredientTOFACITINIB CITRATE
Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Tofacitinib extended-release tablets, 11 mg

NDC 70771-1627-3

30 Tablets

Rx only

11 mg
11 mg

Tofacitinib extended-release tablets, 22 mg

NDC 70771-1628-3

30 Tablets

Rx only

22 mg
22 mg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1741046tofacitinib 11 MG 24HR Extended Release Oral TabletPSN5
2273113tofacitinib 22 MG 24HR Extended Release Oral TabletPSN5
174104624 HR tofacitinib 11 MG Extended Release Oral TabletSCD5
227311324 HR tofacitinib 22 MG Extended Release Oral TabletSCD5
1741046tofacitinib 11 MG (as tofacitinib citrate 17.77 MG) 24 HR Extended Release Oral TabletSY5
1741046tofacitinib 11 MG 24 HR Extended Release Oral TabletSY5

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
TOFACITINIB Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130370710172732GTIN-13: 0370710172732
EAN-13: 0370710172732
GTIN-12: 370710172732
UPC-A: 370710172732
GTIN storage (14 digits): 00370710172732
8997ddda-2a43-45c8-98b0-f1ac03fa3d09-02.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
10e4c2fb-ffa2-728d-14d9-1c6c2f2b27b6Product name420250623

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70771-1627-3tofacitinib30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE305
70771-1627-9tofacitinib90 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE905
70771-1628-3tofacitinib30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE305
70771-1628-9tofacitinib90 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE905

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70771-162770771-1627-3, 70771-1627-9
70771-162870771-1628-3, 70771-1628-9

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 29 matching rows.

Source Document#

Source XML

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A214264-001TOFACITINIB CITRATETOFACITINIB CITRATEEQ 11MG BASETABLET, EXTENDED RELEASE / ORALAB2021-08-19
A214264-002TOFACITINIB CITRATETOFACITINIB CITRATEEQ 22MG BASETABLET, EXTENDED RELEASE / ORALAB2021-08-19

Therapeutic equivalence codes#

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

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

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 · 72 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A214264-001TOFACITINIB CITRATEEQ 11MG BASETABLET, EXTENDED RELEASE / ORALAB2021-08-19c2088c7a36db…
2026-10-15 13:18:302026-09A214264-002TOFACITINIB CITRATEEQ 22MG BASETABLET, EXTENDED RELEASE / ORALAB2021-08-19c2088c7a36db…
2026-09-14 22:38:342026-08A214264-001TOFACITINIB CITRATEEQ 11MG BASETABLET, EXTENDED RELEASE / ORALAB2021-08-1984e616aacf4f…
2026-09-14 22:38:342026-08A214264-002TOFACITINIB CITRATEEQ 22MG BASETABLET, EXTENDED RELEASE / ORALAB2021-08-1984e616aacf4f…
2026-08-18 06:07:402026-07A214264-001TOFACITINIB CITRATEEQ 11MG BASETABLET, EXTENDED RELEASE / ORALAB2021-08-19caaa826d4ba7…
2026-08-18 06:07:402026-07A214264-002TOFACITINIB CITRATEEQ 22MG BASETABLET, EXTENDED RELEASE / ORALAB2021-08-19caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A214264-001TOFACITINIB CITRATEEQ 11MG BASETABLET, EXTENDED RELEASE / ORAL2021-08-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214264-002TOFACITINIB CITRATEEQ 22MG BASETABLET, EXTENDED RELEASE / ORAL2021-08-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214264-001TOFACITINIB CITRATEEQ 11MG BASETABLET, EXTENDED RELEASE / ORAL2021-08-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214264-002TOFACITINIB CITRATEEQ 22MG BASETABLET, EXTENDED RELEASE / ORAL2021-08-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08A214264-001TOFACITINIBEQ 11MG BASETABLET, EXTENDED RELEASE / ORAL2021-08-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214264-002TOFACITINIBEQ 22MG BASETABLET, EXTENDED RELEASE / ORAL2021-08-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214264-001TOFACITINIBEQ 11MG BASETABLET, EXTENDED RELEASE / ORAL2021-08-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214264-002TOFACITINIBEQ 22MG BASETABLET, EXTENDED RELEASE / ORAL2021-08-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214264-001TOFACITINIBEQ 11MG BASETABLET, EXTENDED RELEASE / ORAL2021-08-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214264-002TOFACITINIBEQ 22MG BASETABLET, EXTENDED RELEASE / ORAL2021-08-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214264-001TOFACITINIBEQ 11MG BASETABLET, EXTENDED RELEASE / ORAL2021-08-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214264-002TOFACITINIBEQ 22MG BASETABLET, EXTENDED RELEASE / ORAL2021-08-1903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214264-001TOFACITINIBEQ 11MG BASETABLET, EXTENDED RELEASE / ORAL2021-08-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214264-002TOFACITINIBEQ 22MG BASETABLET, EXTENDED RELEASE / ORAL2021-08-192680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214264-001TOFACITINIBEQ 11MG BASETABLET, EXTENDED RELEASE / ORAL2021-08-195bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214264-002TOFACITINIBEQ 22MG BASETABLET, EXTENDED RELEASE / ORAL2021-08-195bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214264-001TOFACITINIBEQ 11MG BASETABLET, EXTENDED RELEASE / ORAL2021-08-19d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214264-002TOFACITINIBEQ 22MG BASETABLET, EXTENDED RELEASE / ORAL2021-08-19d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A214264-001TOFACITINIBEQ 11MG BASETABLET, EXTENDED RELEASE / ORAL2021-08-19d06236e962d9…
2024-10-29 15:01 UTC2024-10A214264-002TOFACITINIBEQ 22MG BASETABLET, EXTENDED RELEASE / ORAL2021-08-19d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214264-001TOFACITINIBEQ 11MG BASETABLET, EXTENDED RELEASE / ORAL2021-08-1979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214264-002TOFACITINIBEQ 22MG BASETABLET, EXTENDED RELEASE / ORAL2021-08-1979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214264-001TOFACITINIBEQ 11MG BASETABLET, EXTENDED RELEASE / ORAL2021-08-19301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214264-002TOFACITINIBEQ 22MG BASETABLET, EXTENDED RELEASE / ORAL2021-08-19301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214264-001TOFACITINIBEQ 11MG BASETABLET, EXTENDED RELEASE / ORAL2021-08-191e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214264-002TOFACITINIBEQ 22MG BASETABLET, EXTENDED RELEASE / ORAL2021-08-191e350fbaab3a…
2024-05-31 18:47 UTC2024-05A214264-001TOFACITINIBEQ 11MG BASETABLET, EXTENDED RELEASE / ORAL2021-08-198072bd15b7f6…
2024-05-31 18:47 UTC2024-05A214264-002TOFACITINIBEQ 22MG BASETABLET, EXTENDED RELEASE / ORAL2021-08-198072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A214264-001TOFACITINIBEQ 11MG BASETABLET, EXTENDED RELEASE / ORAL2021-08-195c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A214264-002TOFACITINIBEQ 22MG BASETABLET, EXTENDED RELEASE / ORAL2021-08-195c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A214264-001TOFACITINIBEQ 11MG BASETABLET, EXTENDED RELEASE / ORAL2021-08-195d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A214264-002TOFACITINIBEQ 22MG BASETABLET, EXTENDED RELEASE / ORAL2021-08-195d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A214264-001TOFACITINIBEQ 11MG BASETABLET, EXTENDED RELEASE / ORAL2021-08-194b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A214264-002TOFACITINIBEQ 22MG BASETABLET, EXTENDED RELEASE / ORAL2021-08-194b0b4de00fa7…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-10-15 13:18:302026-09A214264-001AB1c2088c7a36db…
2026-10-15 13:18:302026-09A214264-002AB1c2088c7a36db…
2026-09-14 22:38:342026-08A214264-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A214264-002AB184e616aacf4f…
2026-08-18 06:07:402026-07A214264-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A214264-002AB1caaa826d4ba7…
2021-12-28 21:50 UTC2021-12A214264-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A214264-002AB1782e0a99824c…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A214264-001AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A214264-002AB1a50c72e98297…

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
tofacitinibTOFACITINIBZydus Lifesciences Limitedac0b26d5-1352-42ff-b5ea-3eb02d8508a42026-05-12Exact identifier
ndc (package): 70771-1627-9
ndc (package): 70771-1628-3
ndc (package): 70771-1628-9
ndc (package): 70771-1627-3
ndc (product): 70771-1627
ndc (product): 70771-1628
ndc11 (package): 70771162703
ndc11 (package): 70771162709
ndc11 (package): 70771162809
ndc11 (package): 70771162803
spl id: 8997ddda-2a43-45c8-98b0-f1ac03fa3d09
spl set id: ac0b26d5-1352-42ff-b5ea-3eb02d8508a4

Reported adverse events (FAERS/openFDA)#

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