JAKAFI XR
- Product NDC
- 50881-055
- 11-digit product format
- 508810055
- Labeler code
- 50881
- Product ID
- 50881-055_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
- 55 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- JAKAFI XR
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| RUXOLITINIB | 55 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 82S8X8XX8H |
| Rxcui | 1193331, 1193337, 1193339, 1193341, 1193343, 1193345, 1193347, 1193349, 1193351, 1193353, 2743012, 2743016, 2743019, 2743022, 2743025, 2743028, 2743032, 2743035, 2743041, 2743044 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 50881-055-08 | 50881005508 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50881-055-08) | 2026-05-01 | No | No | Historical |