FDA.reportPublic FDA data

JAKAFI XR

Product NDC
50881-011
11-digit product format
508810011
Labeler code
50881
Product ID
50881-011_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
11 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
IngredientStrength
RUXOLITINIB11 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii82S8X8XX8H
Rxcui1193331, 1193337, 1193339, 1193341, 1193343, 1193345, 1193347, 1193349, 1193351, 1193353, 2743012, 2743016, 2743019, 2743022, 2743025, 2743028, 2743032, 2743035, 2743041, 2743044

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
54477ffc-bf5d-4583-bcf6-d041bdba36f1Product name120220316
95a946d8-a784-4eb7-bff4-2194e4331c6fProduct name120190828

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50881-011-08JAKAFI XR30 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE3040

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1193337Jakafi 10 MG Oral TabletPSNf1c82580-87ae-11e0-bc84-0002a5d5c51b40
1193345Jakafi 15 MG Oral TabletPSNf1c82580-87ae-11e0-bc84-0002a5d5c51b40
1193349Jakafi 20 MG Oral TabletPSNf1c82580-87ae-11e0-bc84-0002a5d5c51b40
1193353Jakafi 25 MG Oral TabletPSNf1c82580-87ae-11e0-bc84-0002a5d5c51b40
1193341Jakafi 5 MG Oral TabletPSNf1c82580-87ae-11e0-bc84-0002a5d5c51b40
2743016Jakafi XR 11 MG 24HR Extended Release Oral TabletPSNf1c82580-87ae-11e0-bc84-0002a5d5c51b40
2743022Jakafi XR 22 MG 24HR Extended Release Oral TabletPSNf1c82580-87ae-11e0-bc84-0002a5d5c51b40
2743028Jakafi XR 33 MG 24HR Extended Release Oral TabletPSNf1c82580-87ae-11e0-bc84-0002a5d5c51b40
2743035Jakafi XR 44 MG 24HR Extended Release Oral TabletPSNf1c82580-87ae-11e0-bc84-0002a5d5c51b40
2743044Jakafi XR 55 MG 24HR Extended Release Oral TabletPSNf1c82580-87ae-11e0-bc84-0002a5d5c51b40
1193331ruxolitinib 10 MG Oral TabletPSNf1c82580-87ae-11e0-bc84-0002a5d5c51b40
2743012ruxolitinib 11 MG 24HR Extended Release Oral TabletPSNf1c82580-87ae-11e0-bc84-0002a5d5c51b40
1193343ruxolitinib 15 MG Oral TabletPSNf1c82580-87ae-11e0-bc84-0002a5d5c51b40
1193347ruxolitinib 20 MG Oral TabletPSNf1c82580-87ae-11e0-bc84-0002a5d5c51b40
2743019ruxolitinib 22 MG 24HR Extended Release Oral TabletPSNf1c82580-87ae-11e0-bc84-0002a5d5c51b40
1193351ruxolitinib 25 MG Oral TabletPSNf1c82580-87ae-11e0-bc84-0002a5d5c51b40
2743025ruxolitinib 33 MG 24HR Extended Release Oral TabletPSNf1c82580-87ae-11e0-bc84-0002a5d5c51b40
2743032ruxolitinib 44 MG 24HR Extended Release Oral TabletPSNf1c82580-87ae-11e0-bc84-0002a5d5c51b40
1193339ruxolitinib 5 MG Oral TabletPSNf1c82580-87ae-11e0-bc84-0002a5d5c51b40
2743041ruxolitinib 55 MG 24HR Extended Release Oral TabletPSNf1c82580-87ae-11e0-bc84-0002a5d5c51b40
274301624 HR ruxolitinib 11 MG Extended Release Oral Tablet [Jakafi]SBDf1c82580-87ae-11e0-bc84-0002a5d5c51b40
274302224 HR ruxolitinib 22 MG Extended Release Oral Tablet [Jakafi]SBDf1c82580-87ae-11e0-bc84-0002a5d5c51b40
274302824 HR ruxolitinib 33 MG Extended Release Oral Tablet [Jakafi]SBDf1c82580-87ae-11e0-bc84-0002a5d5c51b40
274303524 HR ruxolitinib 44 MG Extended Release Oral Tablet [Jakafi]SBDf1c82580-87ae-11e0-bc84-0002a5d5c51b40
274304424 HR ruxolitinib 55 MG Extended Release Oral Tablet [Jakafi]SBDf1c82580-87ae-11e0-bc84-0002a5d5c51b40
1193337ruxolitinib 10 MG Oral Tablet [Jakafi]SBDf1c82580-87ae-11e0-bc84-0002a5d5c51b40
1193345ruxolitinib 15 MG Oral Tablet [Jakafi]SBDf1c82580-87ae-11e0-bc84-0002a5d5c51b40
1193349ruxolitinib 20 MG Oral Tablet [Jakafi]SBDf1c82580-87ae-11e0-bc84-0002a5d5c51b40
1193353ruxolitinib 25 MG Oral Tablet [Jakafi]SBDf1c82580-87ae-11e0-bc84-0002a5d5c51b40
1193341ruxolitinib 5 MG Oral Tablet [Jakafi]SBDf1c82580-87ae-11e0-bc84-0002a5d5c51b40
274301224 HR ruxolitinib 11 MG Extended Release Oral TabletSCDf1c82580-87ae-11e0-bc84-0002a5d5c51b40
274301924 HR ruxolitinib 22 MG Extended Release Oral TabletSCDf1c82580-87ae-11e0-bc84-0002a5d5c51b40
274302524 HR ruxolitinib 33 MG Extended Release Oral TabletSCDf1c82580-87ae-11e0-bc84-0002a5d5c51b40
274303224 HR ruxolitinib 44 MG Extended Release Oral TabletSCDf1c82580-87ae-11e0-bc84-0002a5d5c51b40
274304124 HR ruxolitinib 55 MG Extended Release Oral TabletSCDf1c82580-87ae-11e0-bc84-0002a5d5c51b40
1193331ruxolitinib 10 MG Oral TabletSCDf1c82580-87ae-11e0-bc84-0002a5d5c51b40
1193343ruxolitinib 15 MG Oral TabletSCDf1c82580-87ae-11e0-bc84-0002a5d5c51b40
1193347ruxolitinib 20 MG Oral TabletSCDf1c82580-87ae-11e0-bc84-0002a5d5c51b40
1193351ruxolitinib 25 MG Oral TabletSCDf1c82580-87ae-11e0-bc84-0002a5d5c51b40
1193339ruxolitinib 5 MG Oral TabletSCDf1c82580-87ae-11e0-bc84-0002a5d5c51b40
1193337Jakafi (as ruxolitinib phosphate) 10 MG Oral TabletSYf1c82580-87ae-11e0-bc84-0002a5d5c51b40
1193337Jakafi 10 MG Oral TabletSYf1c82580-87ae-11e0-bc84-0002a5d5c51b40
1193345Jakafi 15 MG Oral TabletSYf1c82580-87ae-11e0-bc84-0002a5d5c51b40
1193349Jakafi 20 MG Oral TabletSYf1c82580-87ae-11e0-bc84-0002a5d5c51b40
1193353Jakafi 25 MG Oral TabletSYf1c82580-87ae-11e0-bc84-0002a5d5c51b40
1193341Jakafi 5 MG Oral TabletSYf1c82580-87ae-11e0-bc84-0002a5d5c51b40
2743016Jakafi XR 11 MG 24 HR Extended Release Oral TabletSYf1c82580-87ae-11e0-bc84-0002a5d5c51b40
2743022Jakafi XR 22 MG 24 HR Extended Release Oral TabletSYf1c82580-87ae-11e0-bc84-0002a5d5c51b40
2743028Jakafi XR 33 MG 24 HR Extended Release Oral TabletSYf1c82580-87ae-11e0-bc84-0002a5d5c51b40
2743035Jakafi XR 44 MG 24 HR Extended Release Oral TabletSYf1c82580-87ae-11e0-bc84-0002a5d5c51b40
2743044Jakafi XR 55 MG 24 HR Extended Release Oral TabletSYf1c82580-87ae-11e0-bc84-0002a5d5c51b40
1193331ruxolitinib (as ruxolitinib phosphate) 10 MG Oral TabletSYf1c82580-87ae-11e0-bc84-0002a5d5c51b40
1193343ruxolitinib (as ruxolitinib phosphate) 15 MG Oral TabletSYf1c82580-87ae-11e0-bc84-0002a5d5c51b40
1193347ruxolitinib (as ruxolitinib phosphate) 20 MG Oral TabletSYf1c82580-87ae-11e0-bc84-0002a5d5c51b40
1193351ruxolitinib (as ruxolitinib phosphate) 25 MG Oral TabletSYf1c82580-87ae-11e0-bc84-0002a5d5c51b40
1193339ruxolitinib (as ruxolitinib phosphate) 5 MG Oral TabletSYf1c82580-87ae-11e0-bc84-0002a5d5c51b40
2743012ruxolitinib 11 MG 24 HR Extended Release Oral TabletSYf1c82580-87ae-11e0-bc84-0002a5d5c51b40
2743019ruxolitinib 22 MG 24 HR Extended Release Oral TabletSYf1c82580-87ae-11e0-bc84-0002a5d5c51b40
2743025ruxolitinib 33 MG 24 HR Extended Release Oral TabletSYf1c82580-87ae-11e0-bc84-0002a5d5c51b40
2743032ruxolitinib 44 MG 24 HR Extended Release Oral TabletSYf1c82580-87ae-11e0-bc84-0002a5d5c51b40
2743041ruxolitinib 55 MG 24 HR Extended Release Oral TabletSYf1c82580-87ae-11e0-bc84-0002a5d5c51b40

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50881-011-085088100110830 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50881-011-08) 2026-05-01NoNoCurrent