JAKAFI XR
- Product NDC
- 50881-044
- 11-digit product format
- 508810044
- Labeler code
- 50881
- Product ID
- 50881-044_baf91401-9bd0-4ce6-a5c4-7ca5c572f106
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ruxolitinib
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Incyte Corporation
- Application
- NDA217180
- Marketing category
- NDA
- Marketing start
- 2026-05-01
- Substance
- RUXOLITINIB
- Active strength
- 44 mg/1
- Pharmacologic classes
- Janus Kinase Inhibitor [EPC], Janus Kinase Inhibitors [MoA], Kinase Inhibitor [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 82S8X8XX8H | RUXOLITINIB | 941678-49-5 | RUXOLITINIB |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 50881-044-08 | 50881004408 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50881-044-08) | 2026-05-01 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| JAKAFI | Incyte Corporation | 2026-05-01 | HUMAN PRESCRIPTION DRUG LABEL | 40 |