Jakafi Xr Tablet, Extended Release
NDC Package 50881-044-08
Package Information
Jakafi Xr (ruxolitinib) tablets is none. This formulation utilizes a tablet, extended release delivery system. Marketed by Incyte Corporation, this product is identified by NDC 50881-044 and is authorized under FDA application NDA217180.
Identification & Billing
- RxCUI: 1193331 - ruxolitinib 10 MG Oral Tablet
- RxCUI: 1193331 - ruxolitinib (as ruxolitinib phosphate) 10 MG Oral Tablet
- RxCUI: 1193337 - Jakafi 10 MG Oral Tablet
- RxCUI: 1193337 - ruxolitinib 10 MG Oral Tablet [Jakafi]
- RxCUI: 1193337 - Jakafi (as ruxolitinib phosphate) 10 MG Oral Tablet
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 50881 - Incyte Corporation
- 50881-044 - Jakafi Xr
- 50881-044-08 - 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC
- 50881-044 - Jakafi Xr
The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.
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Frequently Asked Questions
What is the distribution configuration for this product package?
The code 50881-044-08 identifies a specific commercial package of 30 tablet, extended release in 1 bottle, plastic of Jakafi Xr, a human prescription drug labeled by Incyte Corporation. This tablet, extended release is formulated for oral use and contains ruxolitinib as the active substance.
Is this product currently listed with the FDA?
Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Incyte Corporation on May 01, 2026. The current certification is valid through December 31, 2027.
How is this Incyte Corporation product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 50881004408. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.
11-Digit Code Conversion
Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:
Note: The zero is added to the Product segment to maintain the 5-4-2 structure.