tofacitinib
- Product NDC
- 70710-1243
- 11-digit product format
- 707101243
- Labeler code
- 70710
- Product ID
- 70710-1243_ac4bee46-e55b-46c7-a365-0cc6147f0b79
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- tofacitinib
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Zydus Pharmaceuticals USA Inc.
- Application
- ANDA209829
- Marketing category
- ANDA
- Marketing start
- 2026-05-11
- Substance
- TOFACITINIB CITRATE
- Active strength
- 5 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 | 5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | O1FF4DIV0D |
| Rxcui | 1357541 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70710-1243-6 | tofacitinib | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 6 |
| 70710-1243-8 | tofacitinib | 180 in 1 BOTTLE | TABLET, FILM COATED | 180 | | 6 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 70710-1243-6 | 70710124306 | 60 TABLET, FILM COATED in 1 BOTTLE (70710-1243-6) | 2026-05-11 | No | No | Current |
| 70710-1243-8 | 70710124308 | 180 TABLET, FILM COATED in 1 BOTTLE (70710-1243-8) | 2026-05-11 | No | No | Current |