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#
Label contents#
Full prescribing information#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1741046 | tofacitinib 11 MG 24HR Extended Release Oral Tablet | PSN | 5 |
| 2273113 | tofacitinib 22 MG 24HR Extended Release Oral Tablet | PSN | 5 |
| 1741046 | 24 HR tofacitinib 11 MG Extended Release Oral Tablet | SCD | 5 |
| 2273113 | 24 HR tofacitinib 22 MG Extended Release Oral Tablet | SCD | 5 |
| 1741046 | tofacitinib 11 MG (as tofacitinib citrate 17.77 MG) 24 HR Extended Release Oral Tablet | SY | 5 |
| 1741046 | tofacitinib 11 MG 24 HR Extended Release Oral Tablet | SY | 5 |
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| TOFACITINIB Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
Product Linked Resources#
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | EAN-13 | 0370710172732 | GTIN-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 | Effective |
|---|---|---|---|
| 10e4c2fb-ffa2-728d-14d9-1c6c2f2b27b6 | Product name | 4 | 20250623 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 70771-1627-3 | tofacitinib | 30 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 30 | 5 | |
| 70771-1627-9 | tofacitinib | 90 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 90 | 5 | |
| 70771-1628-3 | tofacitinib | 30 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 30 | 5 | |
| 70771-1628-9 | tofacitinib | 90 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 90 | 5 |
Products#
Every source-derived product name is available through these pages.
- tofacitinib
- TOFACITINIB CITRATE
- D&C RED NO. 27 ALUMINUM LAKE
- ETHYLCELLULOSE (7 MPA.S)
- FD&C BLUE NO. 2--ALUMINUM LAKE
- FERRIC OXIDE RED
- FERROSOFERRIC OXIDE
- HYPROMELLOSE 2208 (100 MPA.S)
- HYPROMELLOSE 2208 (4000 MPA.S)
- HYPROMELLOSE 2910 (6 MPA.S)
- LACTOSE MONOHYDRATE
- MAGNESIUM STEARATE
- POLYETHYLENE GLYCOL 4000
- PROPYLENE GLYCOL
- SHELLAC
- SODIUM LAURYL SULFATE
- TITANIUM DIOXIDE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 70771-1627 | 70771-1627-3, 70771-1627-9 |
| 70771-1628 | 70771-1628-3, 70771-1628-9 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
Orange Book application contexts#
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book products#
| 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#
| 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.
| 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 | A214264-001 | TOFACITINIB CITRATE | EQ 11MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2021-08-19 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | A214264-002 | TOFACITINIB CITRATE | EQ 22MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2021-08-19 | c2088c7a36db… | |
| 2026-09-14 22:38:34 | 2026-08 | A214264-001 | TOFACITINIB CITRATE | EQ 11MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2021-08-19 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A214264-002 | TOFACITINIB CITRATE | EQ 22MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2021-08-19 | 84e616aacf4f… | |
| 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… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A214264-001 | AB | 1 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | A214264-002 | AB | 1 | c2088c7a36db… |
| 2026-09-14 22:38:34 | 2026-08 | A214264-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A214264-002 | AB | 1 | 84e616aacf4f… |
| 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… |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| tofacitinib | TOFACITINIB | Zydus Lifesciences Limited | ac0b26d5-1352-42ff-b5ea-3eb02d8508a4 | 2026-05-12 | 70771-1627-9 70771-1628-3 70771-1628-9 70771-1627-3 70771-1627 70771-1628 70771162703 70771162709 70771162809 70771162803 8997ddda-2a43-45c8-98b0-f1ac03fa3d09 ac0b26d5-1352-42ff-b5ea-3eb02d8508a4 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.

