Jakafi XR (ruxolitinib) NDC 50881-044

NDC codes

FDA NDC Directory

Product NDC (as listed)50881-044Labeler and product segments. Claims need a package NDC.

Product NDC at billing width50881-0044Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
50881-044-08	50881004408	30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50881-044-08)Marketed from May 1, 2026

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): Jakafi XR
Generic name (nonproprietary): ruxolitinib
Active ingredients: Ruxolitinib — 44 mg/1
Dosage form: Tablet, Extended release
Route: Oral
Labeler: Incyte Corporation
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 217180
Marketing start: May 1, 2026
Listing expires: Dec 31, 2027
Other FDA classes: Janus Kinase Inhibitors (Mechanism)
Identifiers: Product ID 50881-044_1c261eb0-f426-47a1-8281-62282d207644SPL ID 1c261eb0-f426-47a1-8281-62282d207644SPL set ID f1c82580-87ae-11e0-bc84-0002a5d5c51bRxCUI 1193331, 1193337, 1193339, 1193341, 1193343, 1193345, 1193347, 1193349, 1193351, 1193353, 2743012, 2743016, 2743019, 2743022, 2743025, 2743028, 2743032, 2743035, 2743041, 2743044UNII 82S8X8XX8HUPC 0350881015601, 0350881055089, 0350881022081, 0350881010606, 0350881005602, 0350881025600, 0350881011085, 0350881033087, 0350881020605, 0350881044083
Pharmacologic class: Janus Kinase Inhibitor; Kinase Inhibitor

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N450881004408 followed by a unit qualifier and the quantity

Package 50881-0044-08. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective Jul 20, 2026.

Indications (excerpt from the label)

JAKAFI/JAKAFI XR is a kinase inhibitor indicated for treatment of: intermediate or high-risk myelofibrosis, including primary myelofibrosis, post-polycythemia vera myelofibrosis, and post-essential thrombocythemia myelofibrosis in adults. ( 1.1 ) polycythemia vera in adults who have had an inadequate response to or are intolerant of hydroxyurea. ( 1.2 ) steroid-refractory acute graft-versus-host disease in adult and pediatric patients 12 years and older. ( 1.3 ) chronic graft-versus-host disease after failure of one or two lines of systemic therapy in adult and pediatric patients 12 years and older. ( 1.4 ) 1.1 Myelofibrosis JAKAFI/JAKAFI XR is indicated for treatment of intermediate or high…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 217180

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 217180
Product	Strength	Form · route	Labeler	Product NDC
Jakafi XRruxolitinib	Ruxolitinib 11 mg/1	Tablet, Extended releaseOral	Incyte Corporation	50881-011
Jakafi XRruxolitinib	Ruxolitinib 22 mg/1	Tablet, Extended releaseOral	Incyte Corporation	50881-022
Jakafi XRruxolitinib	Ruxolitinib 33 mg/1	Tablet, Extended releaseOral	Incyte Corporation	50881-033
Jakafi XRruxolitinib	Ruxolitinib 55 mg/1	Tablet, Extended releaseOral	Incyte Corporation	50881-055