tofacitinib
- Product NDC
- 70710-1353
- 11-digit product format
- 707101353
- Labeler code
- 70710
- Product ID
- 70710-1353_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
- 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- tofacitinib
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| TOFACITINIB CITRATE | 11 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | O1FF4DIV0D |
| Rxcui | 1741046, 2273113 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70710-1353-3 | tofacitinib | 30 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 30 | | 6 |
| 70710-1353-9 | tofacitinib | 90 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 90 | | 6 |
DailyMed RxNorm Mappings#
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 70710-1353-3 | 70710135303 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (70710-1353-3) | 2026-05-20 | No | No | Current |
| 70710-1353-9 | 70710135309 | 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (70710-1353-9) | 2026-05-20 | No | No | Current |