Tofacitinib
- Product NDC
- 60505-4858
- 11-digit product format
- 605054858
- Labeler code
- 60505
- Product ID
- 60505-4858_7fee4b25-0b5f-096e-4f0f-de19577e29b1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- tofacitinib
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Apotex Corp.
- Application
- ANDA220458
- Marketing category
- ANDA
- Marketing start
- 2026-06-03
- Substance
- TOFACITINIB CITRATE
- Active strength
- 11 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
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A220458-001 | TOFACITINIB CITRATE | TOFACITINIB CITRATE | EQ 11MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2026-06-03 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A220458-001 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A220458-001 | TOFACITINIB CITRATE | EQ 11MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2026-06-03 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A220458-001 | TOFACITINIB CITRATE | EQ 11MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2026-06-03 | caaa826d4ba7… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A220458-001 | TOFACITINIB CITRATE | EQ 11MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2026-06-03 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A220458-001 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A220458-001 | AB | 1 | caaa826d4ba7… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A220458-001 | AB | 1 | a50c72e98297… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Tofacitinib
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| TOFACITINIB CITRATE | 11 mg/1 |
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 | Apotex Corp. | dd62a2b8-300b-d92b-7b27-a30eaa68fdd3 | 2026-07-27 | Boxed warning, Warnings, Adverse reactions | 220458 ANDA220458 60505-4858 |
| Tofacitinib | TOFACITINIB | AvKARE | 5502f252-2b39-2cfd-e063-6394a90a8a48 | 2026-06-24 | Boxed warning, Warnings, Adverse reactions | 220458 ANDA220458 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 60505-4858-3 | 60505485803 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (60505-4858-3) | 2026-06-09 | No | No | Current |