NDC codes

FDA NDC Directory
Product NDC (as listed)50881-010Labeler and product segments. Claims need a package NDC.
Product NDC at billing width50881-0010Add 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 NDC11-digit (billing)PackageCopy
50881-010-015088100100128 TABLET in 1 BOTTLE, PLASTIC (50881-010-01)Marketed from Nov 16, 2011
50881-010-605088100106060 TABLET in 1 BOTTLE, PLASTIC (50881-010-60)Marketed from Nov 16, 2011

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
Generic name (nonproprietary)
ruxolitinib
Active ingredients
Ruxolitinib — 10 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Incyte CorporationNDC labeler code 50881
Product type
Prescription drug
Marketing category
NDA — New Drug ApplicationApplication NDA 202192
Marketing start
Listing expires
Other FDA classes
Janus Kinase Inhibitors (Mechanism)
Identifiers
Product ID 50881-010_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

N450881001001 followed by a unit qualifier and the quantity

Package 50881-0010-01. 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 .

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)

About NDC 50881-010

What is NDC 50881-010?
50881-010 is the product NDC for Jakafi (ruxolitinib), Ruxolitinib 10 mg/1 tablet, listed with the FDA by Incyte Corporation. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Jakafi (Ruxolitinib).
What is the active ingredient?
Ruxolitinib.
Who is the labeler?
Incyte Corporation, NDC labeler code 50881. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Jakafi?
4 other product NDCs are listed under this name. See all Jakafi NDCs.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Jakafi NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
JakafiruxolitinibRuxolitinib 5 mg/1TabletOralIncyte Corporation50881-00550881-0005-60
JakafiruxolitinibRuxolitinib 15 mg/1TabletOralIncyte Corporation50881-01550881-0015-60
JakafiruxolitinibRuxolitinib 20 mg/1TabletOralIncyte Corporation50881-02050881-0020-60
JakafiruxolitinibRuxolitinib 25 mg/1TabletOralIncyte Corporation50881-02550881-0025-60

Other NDCs under NDA 202192

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

FDA NDC Directory listings under NDA 202192
ProductStrengthForm · routeLabelerProduct NDC
JakafiruxolitinibRuxolitinib 5 mg/1TabletOralIncyte Corporation50881-005
JakafiruxolitinibRuxolitinib 20 mg/1TabletOralIncyte Corporation50881-020
JakafiruxolitinibRuxolitinib 15 mg/1TabletOralIncyte Corporation50881-015
JakafiruxolitinibRuxolitinib 25 mg/1TabletOralIncyte Corporation50881-025

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