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JAKAFI XR
ruxolitinib · Tablet, Extended Release
Prescription NDA RLD
Informational index, not medical advice. Content is reproduced from
public FDA and NLM data. Always confirm against the manufacturer's current
prescribing information. Report adverse events to FDA MedWatch.
Overview
Brand name
JAKAFI XR
Generic name
ruxolitinib
Dosage form
Tablet, Extended Release
Route
Oral
Marketing category
NDA · NDA
Labeler
Incyte Corporation
Product type
Human Prescription Drug
DEA schedule
Not scheduled
Active ingredients
5
NDC product codes
5
Packages
5
Data completeness
60%
of corroborating sources present
Active ingredients
Source: NDC DirectoryForms, strengths and routes
Source: NDC DirectoryDosage form
Tablet, Extended Release
Route of administration
Oral
Presentations
10
Pharmacologic classes are listed in the class section below.
Pharmacologic class
Source: NDC Directory| Class | Type | Browse |
|---|---|---|
| Janus Kinase Inhibitor [EPC] | EPC | All 15 members |
| Janus Kinase Inhibitors [MoA] | MoA | All 15 members |
| Kinase Inhibitor [EPC] | EPC | All 89 members |
Regulatory status
Source: Drugs@FDANDC DirectoryApplication number
217180
Application type
NDA · New Drug Application
Approval date
May 1, 2026
Sponsor
INCYTE CORP
Products on application
5
Submissions recorded
2
| Product | Trade name | Form | Strength | Ingredient | Status | TE | Flags |
|---|---|---|---|---|---|---|---|
| 217180-001 | JAKAFI XR | TABLET, EXTENDED RELEASE | RUXOLITINIB PHOSPHATE | Prescription | — | RLD | |
| 217180-002 | JAKAFI XR | TABLET, EXTENDED RELEASE | RUXOLITINIB PHOSPHATE | Prescription | — | RLD | |
| 217180-003 | JAKAFI XR | TABLET, EXTENDED RELEASE | RUXOLITINIB PHOSPHATE | Prescription | — | RLD | |
| 217180-004 | JAKAFI XR | TABLET, EXTENDED RELEASE | RUXOLITINIB PHOSPHATE | Prescription | — | RLD | |
| 217180-005 | JAKAFI XR | TABLET, EXTENDED RELEASE | RUXOLITINIB PHOSPHATE | Prescription | — | RLD RS |
Therapeutic equivalence
Source: Orange BookTE code
—
Reference Listed Drug
Yes
Reference Standard
Yes
Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.
Patents and exclusivity
Source: Orange Book| Patent | Expires | Product | Substance | Use code | Submitted |
|---|---|---|---|---|---|
| 9814722 | December 12, 2026 | 001 | No | U-3226 | May 28, 2026 |
| 9814722 | December 12, 2026 | 001 | No | U-3230 | May 28, 2026 |
| 9206187 | December 12, 2026 | 001 | No | U-3227 | May 28, 2026 |
| 9206187 | December 12, 2026 | 001 | No | U-3228 | May 28, 2026 |
| 9079912 | December 12, 2026 | 001 | No | U-3227 | May 28, 2026 |
| 9079912 | December 12, 2026 | 001 | No | U-3228 | May 28, 2026 |
| 9079912 | December 12, 2026 | 001 | No | U-3230 | May 28, 2026 |
| 9079912 | December 12, 2026 | 001 | No | U-3226 | May 28, 2026 |
| 11744832 | December 12, 2026 | 001 | No | U-3226 | May 28, 2026 |
| 11744832 | December 12, 2026 | 001 | No | U-3230 | May 28, 2026 |
| 8530485 | December 12, 2026 | 001 | No | May 28, 2026 | |
| 9814722 | December 12, 2026 | 002 | No | U-3226 | May 28, 2026 |
| 9814722 | December 12, 2026 | 002 | No | U-3230 | May 28, 2026 |
| 9206187 | December 12, 2026 | 002 | No | U-3227 | May 28, 2026 |
| 9206187 | December 12, 2026 | 002 | No | U-3228 | May 28, 2026 |
| 9079912 | December 12, 2026 | 002 | No | U-3227 | May 28, 2026 |
| 9079912 | December 12, 2026 | 002 | No | U-3228 | May 28, 2026 |
| 9079912 | December 12, 2026 | 002 | No | U-3230 | May 28, 2026 |
| 9079912 | December 12, 2026 | 002 | No | U-3226 | May 28, 2026 |
| 11744832 | December 12, 2026 | 002 | No | U-3226 | May 28, 2026 |
| 11744832 | December 12, 2026 | 002 | No | U-3230 | May 28, 2026 |
| 8530485 | December 12, 2026 | 002 | No | May 28, 2026 | |
| 9814722 | December 12, 2026 | 003 | No | U-3226 | May 28, 2026 |
| 9814722 | December 12, 2026 | 003 | No | U-3230 | May 28, 2026 |
| 9206187 | December 12, 2026 | 003 | No | U-3227 | May 28, 2026 |
| 9206187 | December 12, 2026 | 003 | No | U-3228 | May 28, 2026 |
| 9079912 | December 12, 2026 | 003 | No | U-3227 | May 28, 2026 |
| 9079912 | December 12, 2026 | 003 | No | U-3228 | May 28, 2026 |
| 9079912 | December 12, 2026 | 003 | No | U-3230 | May 28, 2026 |
| 9079912 | December 12, 2026 | 003 | No | U-3226 | May 28, 2026 |
| 11744832 | December 12, 2026 | 003 | No | U-3226 | May 28, 2026 |
| 11744832 | December 12, 2026 | 003 | No | U-3230 | May 28, 2026 |
| 8530485 | December 12, 2026 | 003 | No | May 28, 2026 | |
| 9814722 | December 12, 2026 | 004 | No | U-3226 | May 28, 2026 |
| 9814722 | December 12, 2026 | 004 | No | U-3230 | May 28, 2026 |
| 9206187 | December 12, 2026 | 004 | No | U-3227 | May 28, 2026 |
| 9206187 | December 12, 2026 | 004 | No | U-3228 | May 28, 2026 |
| 9079912 | December 12, 2026 | 004 | No | U-3227 | May 28, 2026 |
| 9079912 | December 12, 2026 | 004 | No | U-3228 | May 28, 2026 |
| 9079912 | December 12, 2026 | 004 | No | U-3230 | May 28, 2026 |
| 9079912 | December 12, 2026 | 004 | No | U-3226 | May 28, 2026 |
| 11744832 | December 12, 2026 | 004 | No | U-3226 | May 28, 2026 |
| 11744832 | December 12, 2026 | 004 | No | U-3230 | May 28, 2026 |
| 8530485 | December 12, 2026 | 004 | No | May 28, 2026 | |
| 9814722 | December 12, 2026 | 005 | No | U-3226 | May 28, 2026 |
| 9814722 | December 12, 2026 | 005 | No | U-3230 | May 28, 2026 |
| 9206187 | December 12, 2026 | 005 | No | U-3227 | May 28, 2026 |
| 9206187 | December 12, 2026 | 005 | No | U-3228 | May 28, 2026 |
| 9079912 | December 12, 2026 | 005 | No | U-3227 | May 28, 2026 |
| 9079912 | December 12, 2026 | 005 | No | U-3228 | May 28, 2026 |
| 9079912 | December 12, 2026 | 005 | No | U-3230 | May 28, 2026 |
| 9079912 | December 12, 2026 | 005 | No | U-3226 | May 28, 2026 |
| 11744832 | December 12, 2026 | 005 | No | U-3226 | May 28, 2026 |
| 11744832 | December 12, 2026 | 005 | No | U-3230 | May 28, 2026 |
| 8530485 | December 12, 2026 | 005 | No | May 28, 2026 | |
| 7598257 | December 24, 2027 | 001 | Yes | U-3227 | May 28, 2026 |
| 7598257 | December 24, 2027 | 001 | Yes | U-3228 | May 28, 2026 |
| 8415362 | December 24, 2027 | 001 | Yes | May 28, 2026 | |
| 7598257 | December 24, 2027 | 002 | Yes | U-3227 | May 28, 2026 |
| 7598257 | December 24, 2027 | 002 | Yes | U-3228 | May 28, 2026 |
| 8415362 | December 24, 2027 | 002 | Yes | May 28, 2026 | |
| 7598257 | December 24, 2027 | 003 | Yes | U-3227 | May 28, 2026 |
| 7598257 | December 24, 2027 | 003 | Yes | U-3228 | May 28, 2026 |
| 8415362 | December 24, 2027 | 003 | Yes | May 28, 2026 | |
| 7598257 | December 24, 2027 | 004 | Yes | U-3227 | May 28, 2026 |
| 7598257 | December 24, 2027 | 004 | Yes | U-3228 | May 28, 2026 |
| 8415362 | December 24, 2027 | 004 | Yes | May 28, 2026 | |
| 7598257 | December 24, 2027 | 005 | Yes | U-3227 | May 28, 2026 |
| 7598257 | December 24, 2027 | 005 | Yes | U-3228 | May 28, 2026 |
| 8415362 | December 24, 2027 | 005 | Yes | May 28, 2026 | |
| 8829013 | June 12, 2028 | 001 | No | U-3227 | May 28, 2026 |
| 8829013 | June 12, 2028 | 001 | No | U-3228 | May 28, 2026 |
| 10016429 | June 12, 2028 | 001 | No | U-3226 | May 28, 2026 |
| 10016429 | June 12, 2028 | 001 | No | U-3230 | May 28, 2026 |
| 8822481 | June 12, 2028 | 001 | No | U-3227 | May 28, 2026 |
| 8822481 | June 12, 2028 | 001 | No | U-3228 | May 28, 2026 |
| 8822481 | June 12, 2028 | 001 | No | U-3230 | May 28, 2026 |
| 8822481 | June 12, 2028 | 001 | No | U-3226 | May 28, 2026 |
| 8722693 | June 12, 2028 | 001 | Yes | May 28, 2026 | |
| 11213528 | June 12, 2028 | 001 | No | May 28, 2026 | |
| 8829013 | June 12, 2028 | 002 | No | U-3227 | May 28, 2026 |
| 8829013 | June 12, 2028 | 002 | No | U-3228 | May 28, 2026 |
| 10016429 | June 12, 2028 | 002 | No | U-3226 | May 28, 2026 |
| 10016429 | June 12, 2028 | 002 | No | U-3230 | May 28, 2026 |
| 8822481 | June 12, 2028 | 002 | No | U-3227 | May 28, 2026 |
| 8822481 | June 12, 2028 | 002 | No | U-3228 | May 28, 2026 |
| 8822481 | June 12, 2028 | 002 | No | U-3230 | May 28, 2026 |
| 8822481 | June 12, 2028 | 002 | No | U-3226 | May 28, 2026 |
| 8722693 | June 12, 2028 | 002 | Yes | May 28, 2026 | |
| 11213528 | June 12, 2028 | 002 | No | May 28, 2026 | |
| 8829013 | June 12, 2028 | 003 | No | U-3227 | May 28, 2026 |
| 8829013 | June 12, 2028 | 003 | No | U-3228 | May 28, 2026 |
| 10016429 | June 12, 2028 | 003 | No | U-3226 | May 28, 2026 |
| 10016429 | June 12, 2028 | 003 | No | U-3230 | May 28, 2026 |
| 8822481 | June 12, 2028 | 003 | No | U-3227 | May 28, 2026 |
| 8822481 | June 12, 2028 | 003 | No | U-3228 | May 28, 2026 |
| 8822481 | June 12, 2028 | 003 | No | U-3230 | May 28, 2026 |
| 8822481 | June 12, 2028 | 003 | No | U-3226 | May 28, 2026 |
| 11213528 | June 12, 2028 | 003 | No | May 28, 2026 | |
| 8722693 | June 12, 2028 | 003 | Yes | May 28, 2026 | |
| 8829013 | June 12, 2028 | 004 | No | U-3227 | May 28, 2026 |
| 8829013 | June 12, 2028 | 004 | No | U-3228 | May 28, 2026 |
| 10016429 | June 12, 2028 | 004 | No | U-3226 | May 28, 2026 |
| 10016429 | June 12, 2028 | 004 | No | U-3230 | May 28, 2026 |
| 8822481 | June 12, 2028 | 004 | No | U-3227 | May 28, 2026 |
| 8822481 | June 12, 2028 | 004 | No | U-3228 | May 28, 2026 |
| 8822481 | June 12, 2028 | 004 | No | U-3230 | May 28, 2026 |
| 8822481 | June 12, 2028 | 004 | No | U-3226 | May 28, 2026 |
| 11213528 | June 12, 2028 | 004 | No | May 28, 2026 | |
| 8722693 | June 12, 2028 | 004 | Yes | May 28, 2026 | |
| 8829013 | June 12, 2028 | 005 | No | U-3227 | May 28, 2026 |
| 8829013 | June 12, 2028 | 005 | No | U-3228 | May 28, 2026 |
| 10016429 | June 12, 2028 | 005 | No | U-3226 | May 28, 2026 |
| 10016429 | June 12, 2028 | 005 | No | U-3230 | May 28, 2026 |
| 8822481 | June 12, 2028 | 005 | No | U-3227 | May 28, 2026 |
| 8822481 | June 12, 2028 | 005 | No | U-3228 | May 28, 2026 |
| 8822481 | June 12, 2028 | 005 | No | U-3230 | May 28, 2026 |
| 8822481 | June 12, 2028 | 005 | No | U-3226 | May 28, 2026 |
| 8722693 | June 12, 2028 | 005 | Yes | May 28, 2026 | |
| 11213528 | June 12, 2028 | 005 | No | May 28, 2026 | |
| 8415362*PED | June 24, 2028 | 001 | No | — | |
| 7598257*PED | June 24, 2028 | 001 | No | — | |
| 8415362*PED | June 24, 2028 | 002 | No | — | |
| 7598257*PED | June 24, 2028 | 002 | No | — | |
| 8415362*PED | June 24, 2028 | 003 | No | — | |
| 7598257*PED | June 24, 2028 | 003 | No | — | |
| 8415362*PED | June 24, 2028 | 004 | No | — | |
| 7598257*PED | June 24, 2028 | 004 | No | — | |
| 8415362*PED | June 24, 2028 | 005 | No | — | |
| 7598257*PED | June 24, 2028 | 005 | No | — | |
| 8829013*PED | December 12, 2028 | 001 | No | — | |
| 10016429*PED | December 12, 2028 | 001 | No | — | |
| 8822481*PED | December 12, 2028 | 001 | No | — | |
| 11213528*PED | December 12, 2028 | 001 | No | — | |
| 8722693*PED | December 12, 2028 | 001 | No | — | |
| 8829013*PED | December 12, 2028 | 002 | No | — | |
| 10016429*PED | December 12, 2028 | 002 | No | — | |
| 8822481*PED | December 12, 2028 | 002 | No | — | |
| 11213528*PED | December 12, 2028 | 002 | No | — | |
| 8722693*PED | December 12, 2028 | 002 | No | — | |
| 8829013*PED | December 12, 2028 | 003 | No | — | |
| 10016429*PED | December 12, 2028 | 003 | No | — | |
| 8822481*PED | December 12, 2028 | 003 | No | — | |
| 11213528*PED | December 12, 2028 | 003 | No | — | |
| 8722693*PED | December 12, 2028 | 003 | No | — | |
| 8829013*PED | December 12, 2028 | 004 | No | — | |
| 10016429*PED | December 12, 2028 | 004 | No | — | |
| 8822481*PED | December 12, 2028 | 004 | No | — | |
| 11213528*PED | December 12, 2028 | 004 | No | — | |
| 8722693*PED | December 12, 2028 | 004 | No | — | |
| 8829013*PED | December 12, 2028 | 005 | No | — | |
| 10016429*PED | December 12, 2028 | 005 | No | — | |
| 8822481*PED | December 12, 2028 | 005 | No | — | |
| 11213528*PED | December 12, 2028 | 005 | No | — | |
| 8722693*PED | December 12, 2028 | 005 | No | — | |
| 11576864 | November 14, 2033 | 001 | No | U-3227 | May 28, 2026 |
| 11576864 | November 14, 2033 | 001 | No | U-3228 | May 28, 2026 |
| 11576864 | November 14, 2033 | 001 | No | U-3230 | May 28, 2026 |
| 11576864 | November 14, 2033 | 001 | No | U-3226 | May 28, 2026 |
| 11896717 | November 14, 2033 | 001 | No | U-3227 | May 28, 2026 |
| 11896717 | November 14, 2033 | 001 | No | U-3228 | May 28, 2026 |
| 11896717 | November 14, 2033 | 001 | No | U-3230 | May 28, 2026 |
| 11896717 | November 14, 2033 | 001 | No | U-3226 | May 28, 2026 |
| 11576865 | November 14, 2033 | 001 | No | U-3227 | May 28, 2026 |
| 11576865 | November 14, 2033 | 001 | No | U-3228 | May 28, 2026 |
| 11576865 | November 14, 2033 | 001 | No | U-3230 | May 28, 2026 |
| 11576865 | November 14, 2033 | 001 | No | U-3226 | May 28, 2026 |
| 10874616 | November 14, 2033 | 001 | No | May 28, 2026 | |
| 11576864 | November 14, 2033 | 002 | No | U-3227 | May 28, 2026 |
| 11576864 | November 14, 2033 | 002 | No | U-3228 | May 28, 2026 |
| 11576864 | November 14, 2033 | 002 | No | U-3230 | May 28, 2026 |
| 11576864 | November 14, 2033 | 002 | No | U-3226 | May 28, 2026 |
| 11896717 | November 14, 2033 | 002 | No | U-3227 | May 28, 2026 |
| 11896717 | November 14, 2033 | 002 | No | U-3228 | May 28, 2026 |
| 11896717 | November 14, 2033 | 002 | No | U-3230 | May 28, 2026 |
| 11896717 | November 14, 2033 | 002 | No | U-3226 | May 28, 2026 |
| 11576865 | November 14, 2033 | 002 | No | U-3227 | May 28, 2026 |
| 11576865 | November 14, 2033 | 002 | No | U-3228 | May 28, 2026 |
| 11576865 | November 14, 2033 | 002 | No | U-3230 | May 28, 2026 |
| 11576865 | November 14, 2033 | 002 | No | U-3226 | May 28, 2026 |
| 10874616 | November 14, 2033 | 002 | No | May 28, 2026 | |
| 11576864 | November 14, 2033 | 003 | No | U-3227 | May 28, 2026 |
| 11576864 | November 14, 2033 | 003 | No | U-3228 | May 28, 2026 |
| 11576864 | November 14, 2033 | 003 | No | U-3230 | May 28, 2026 |
| 11576864 | November 14, 2033 | 003 | No | U-3226 | May 28, 2026 |
| 11896717 | November 14, 2033 | 003 | No | U-3227 | May 28, 2026 |
| 11896717 | November 14, 2033 | 003 | No | U-3228 | May 28, 2026 |
| 11896717 | November 14, 2033 | 003 | No | U-3230 | May 28, 2026 |
| 11896717 | November 14, 2033 | 003 | No | U-3226 | May 28, 2026 |
| 11576865 | November 14, 2033 | 003 | No | U-3227 | May 28, 2026 |
| 11576865 | November 14, 2033 | 003 | No | U-3228 | May 28, 2026 |
| 11576865 | November 14, 2033 | 003 | No | U-3230 | May 28, 2026 |
| 11576865 | November 14, 2033 | 003 | No | U-3226 | May 28, 2026 |
| 10874616 | November 14, 2033 | 003 | No | May 28, 2026 | |
| 11576864 | November 14, 2033 | 004 | No | U-3227 | May 28, 2026 |
| 11576864 | November 14, 2033 | 004 | No | U-3228 | May 28, 2026 |
| 11576864 | November 14, 2033 | 004 | No | U-3230 | May 28, 2026 |
| 11576864 | November 14, 2033 | 004 | No | U-3226 | May 28, 2026 |
| 11896717 | November 14, 2033 | 004 | No | U-3227 | May 28, 2026 |
| 11896717 | November 14, 2033 | 004 | No | U-3228 | May 28, 2026 |
| 11896717 | November 14, 2033 | 004 | No | U-3230 | May 28, 2026 |
| 11896717 | November 14, 2033 | 004 | No | U-3226 | May 28, 2026 |
| 11576865 | November 14, 2033 | 004 | No | U-3227 | May 28, 2026 |
| 11576865 | November 14, 2033 | 004 | No | U-3228 | May 28, 2026 |
| 11576865 | November 14, 2033 | 004 | No | U-3230 | May 28, 2026 |
| 11576865 | November 14, 2033 | 004 | No | U-3226 | May 28, 2026 |
| 10874616 | November 14, 2033 | 004 | No | May 28, 2026 | |
| 11576864 | November 14, 2033 | 005 | No | U-3227 | May 28, 2026 |
| 11576864 | November 14, 2033 | 005 | No | U-3228 | May 28, 2026 |
| 11576864 | November 14, 2033 | 005 | No | U-3230 | May 28, 2026 |
| 11576864 | November 14, 2033 | 005 | No | U-3226 | May 28, 2026 |
| 11896717 | November 14, 2033 | 005 | No | U-3227 | May 28, 2026 |
| 11896717 | November 14, 2033 | 005 | No | U-3228 | May 28, 2026 |
| 11896717 | November 14, 2033 | 005 | No | U-3230 | May 28, 2026 |
| 11896717 | November 14, 2033 | 005 | No | U-3226 | May 28, 2026 |
| 11576865 | November 14, 2033 | 005 | No | U-3227 | May 28, 2026 |
| 11576865 | November 14, 2033 | 005 | No | U-3228 | May 28, 2026 |
| 11576865 | November 14, 2033 | 005 | No | U-3230 | May 28, 2026 |
| 11576865 | November 14, 2033 | 005 | No | U-3226 | May 28, 2026 |
| 10874616 | November 14, 2033 | 005 | No | May 28, 2026 | |
| 11337927 | January 17, 2034 | 001 | No | U-3227 | May 28, 2026 |
| 11337927 | January 17, 2034 | 001 | No | U-3228 | May 28, 2026 |
| 11337927 | January 17, 2034 | 001 | No | U-3230 | May 28, 2026 |
| 11337927 | January 17, 2034 | 001 | No | U-3226 | May 28, 2026 |
| 11337927 | January 17, 2034 | 002 | No | U-3227 | May 28, 2026 |
| 11337927 | January 17, 2034 | 002 | No | U-3228 | May 28, 2026 |
| 11337927 | January 17, 2034 | 002 | No | U-3230 | May 28, 2026 |
| 11337927 | January 17, 2034 | 002 | No | U-3226 | May 28, 2026 |
| 11337927 | January 17, 2034 | 003 | No | U-3227 | May 28, 2026 |
| 11337927 | January 17, 2034 | 003 | No | U-3228 | May 28, 2026 |
| 11337927 | January 17, 2034 | 003 | No | U-3230 | May 28, 2026 |
| 11337927 | January 17, 2034 | 003 | No | U-3226 | May 28, 2026 |
| 11337927 | January 17, 2034 | 004 | No | U-3227 | May 28, 2026 |
| 11337927 | January 17, 2034 | 004 | No | U-3228 | May 28, 2026 |
| 11337927 | January 17, 2034 | 004 | No | U-3230 | May 28, 2026 |
| 11337927 | January 17, 2034 | 004 | No | U-3226 | May 28, 2026 |
| 11337927 | January 17, 2034 | 005 | No | U-3227 | May 28, 2026 |
| 11337927 | January 17, 2034 | 005 | No | U-3228 | May 28, 2026 |
| 11337927 | January 17, 2034 | 005 | No | U-3230 | May 28, 2026 |
| 11337927 | January 17, 2034 | 005 | No | U-3226 | May 28, 2026 |
| 10874616*PED | May 14, 2034 | 001 | No | — | |
| 11576864*PED | May 14, 2034 | 001 | No | — | |
| 11896717*PED | May 14, 2034 | 001 | No | — | |
| 11576865*PED | May 14, 2034 | 001 | No | — | |
| 10874616*PED | May 14, 2034 | 002 | No | — | |
| 11576864*PED | May 14, 2034 | 002 | No | — | |
| 11896717*PED | May 14, 2034 | 002 | No | — | |
| 11576865*PED | May 14, 2034 | 002 | No | — | |
| 10874616*PED | May 14, 2034 | 003 | No | — | |
| 11576864*PED | May 14, 2034 | 003 | No | — | |
| 11896717*PED | May 14, 2034 | 003 | No | — | |
| 11576865*PED | May 14, 2034 | 003 | No | — | |
| 10874616*PED | May 14, 2034 | 004 | No | — | |
| 11576864*PED | May 14, 2034 | 004 | No | — | |
| 11896717*PED | May 14, 2034 | 004 | No | — | |
| 11576865*PED | May 14, 2034 | 004 | No | — | |
| 10874616*PED | May 14, 2034 | 005 | No | — | |
| 11576864*PED | May 14, 2034 | 005 | No | — | |
| 11896717*PED | May 14, 2034 | 005 | No | — | |
| 11576865*PED | May 14, 2034 | 005 | No | — | |
| 11337927*PED | July 17, 2034 | 001 | No | — | |
| 11337927*PED | July 17, 2034 | 002 | No | — | |
| 11337927*PED | July 17, 2034 | 003 | No | — | |
| 11337927*PED | July 17, 2034 | 004 | No | — | |
| 11337927*PED | July 17, 2034 | 005 | No | — |
| Code | Expires | Product |
|---|---|---|
| ODE* | September 22, 2028 | 001 |
| ODE* | September 22, 2028 | 002 |
| ODE* | September 22, 2028 | 003 |
| ODE* | September 22, 2028 | 004 |
| ODE* | September 22, 2028 | 005 |
| PED | March 22, 2029 | 001 |
| PED | March 22, 2029 | 002 |
| PED | March 22, 2029 | 003 |
| PED | March 22, 2029 | 004 |
| PED | March 22, 2029 | 005 |
Approval history
Source: Drugs@FDA| Type | No. | Action | Status | Date | Review |
|---|---|---|---|---|---|
| Supplement | 1 | Labeling | Approved | July 20, 2026 | Standard |
| Original application | 1 | Type 5 - New Formulation or New Manufacturer | Approved | May 1, 2026 | Standard |
Adverse event reports
Source: openFDA FAERS71,241
FAERS reports mentioning this drug
A report count is not a risk measure. FAERS accepts voluntary and
mandatory reports without establishing causation, and reporting is influenced by how
widely a drug is used, how long it has been marketed, and media attention. FDA states
that reports “do not prove that the drug caused the event”. Compare rates, not totals.
Attributed to this product's most-reported active ingredient: RUXOLITINIB. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.
Packaging and NDCs
Source: NDC Directory| Package NDC | Product NDC | Labeler | Description | Marketing start |
|---|---|---|---|---|
| 50881-011-08 | 50881-011 | Incyte Corporation | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50881-011-08) | May 1, 2026 |
| 50881-022-08 | 50881-022 | Incyte Corporation | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50881-022-08) | May 1, 2026 |
| 50881-033-08 | 50881-033 | Incyte Corporation | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50881-033-08) | May 1, 2026 |
| 50881-044-08 | 50881-044 | Incyte Corporation | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50881-044-08) | May 1, 2026 |
| 50881-055-08 | 50881-055 | Incyte Corporation | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50881-055-08) | May 1, 2026 |
| 50881-011 | 50881-011 | Incyte Corporation | — | May 1, 2026 |
| 50881-022 | 50881-022 | Incyte Corporation | — | May 1, 2026 |
| 50881-033 | 50881-033 | Incyte Corporation | — | May 1, 2026 |
| 50881-044 | 50881-044 | Incyte Corporation | — | May 1, 2026 |
| 50881-055 | 50881-055 | Incyte Corporation | — | May 1, 2026 |
Sources for this page
| Dataset | Agency | Used for |
|---|---|---|
| NDC Directory | FDA | Identity, ingredients, strengths, forms, routes, labelers, packages |
| Drugs@FDA | FDA | Application, sponsor, submissions, review documents, marketing status |
| Orange Book | FDA | Therapeutic equivalence codes, reference drug flags, patents, exclusivity |
| FAERS | FDA | Adverse event report counts |
Generated September 25, 2026 · 11 sections on this page.