JAKAFI

Product NDC: 50881-005
Requested package NDC: 50881-005-60
11-digit product format: 508810005
Labeler code: 50881
Product ID: 50881-005_baf91401-9bd0-4ce6-a5c4-7ca5c572f106
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ruxolitinib
Dosage form: TABLET
Route: ORAL
Labeler: Incyte Corporation
Application: NDA202192
Marketing category: NDA
Marketing start: 2011-11-16
Substance: RUXOLITINIB
Active strength: 5 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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N202192-001	JAKAFI	RUXOLITINIB PHOSPHATE	EQ 5MG BASE	TABLET / ORAL	RLD	2011-11-16
N202192-002	JAKAFI	RUXOLITINIB PHOSPHATE	EQ 10MG BASE	TABLET / ORAL	RLD	2011-11-16
N202192-003	JAKAFI	RUXOLITINIB PHOSPHATE	EQ 15MG BASE	TABLET / ORAL	RLD	2011-11-16
N202192-004	JAKAFI	RUXOLITINIB PHOSPHATE	EQ 20MG BASE	TABLET / ORAL	RLD	2011-11-16
N202192-005	JAKAFI	RUXOLITINIB PHOSPHATE	EQ 25MG BASE	TABLET / ORAL	RLD, RS	2011-11-16

Orange Book patents#

Current patent rows page 1 of 2 · 145 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N202192-001	9079912	2026-12-12	U-3226		2015-08-04
N202192-001	9079912	2026-12-12	U-3227		2015-08-04
N202192-001	9079912	2026-12-12	U-3228		2015-08-04
N202192-001	9079912	2026-12-12	U-3230		2015-08-04
N202192-001	9814722	2026-12-12	U-3226		2019-06-12
N202192-001	9814722	2026-12-12	U-3230		2019-06-12
N202192-001	9079912*PED	2027-06-12		Pediatric extension
N202192-001	9814722*PED	2027-06-12		Pediatric extension
N202192-001	7598257	2027-12-24	U-3227	Drug substance, Drug product	2011-12-01
N202192-001	7598257	2027-12-24	U-3228	Drug substance, Drug product	2011-12-01
N202192-001	8415362	2027-12-24		Drug substance, Drug product	2013-04-29
N202192-001	10016429	2028-06-12	U-3226		2019-06-12
N202192-001	10016429	2028-06-12	U-3230		2019-06-12
N202192-001	8722693	2028-06-12		Drug substance, Drug product	2014-06-03
N202192-001	8822481	2028-06-12	U-1573		2014-09-24
N202192-001	8822481	2028-06-12	U-3226		2014-09-24
N202192-001	8822481	2028-06-12	U-3227		2014-09-24
N202192-001	8822481	2028-06-12	U-3228		2014-09-24
N202192-001	8822481	2028-06-12	U-3230		2014-09-24
N202192-001	8829013	2028-06-12	U-1201		2014-09-24
N202192-001	8829013	2028-06-12	U-1622		2014-09-24
N202192-001	8829013	2028-06-12	U-3227		2014-09-24
N202192-001	8829013	2028-06-12	U-3228		2014-09-24
N202192-001	7598257*PED	2028-06-24		Pediatric extension
N202192-001	8415362*PED	2028-06-24		Pediatric extension
N202192-001	10016429*PED	2028-12-12		Pediatric extension
N202192-001	8722693*PED	2028-12-12		Pediatric extension
N202192-001	8822481*PED	2028-12-12		Pediatric extension
N202192-001	8829013*PED	2028-12-12		Pediatric extension
N202192-002	9079912	2026-12-12	U-3226		2015-08-04
N202192-002	9079912	2026-12-12	U-3227		2015-08-04
N202192-002	9079912	2026-12-12	U-3228		2015-08-04
N202192-002	9079912	2026-12-12	U-3230		2015-08-04
N202192-002	9814722	2026-12-12	U-3226		2019-06-12
N202192-002	9814722	2026-12-12	U-3230		2019-06-12
N202192-002	9079912*PED	2027-06-12		Pediatric extension
N202192-002	9814722*PED	2027-06-12		Pediatric extension
N202192-002	7598257	2027-12-24	U-3227	Drug substance, Drug product	2011-12-01
N202192-002	7598257	2027-12-24	U-3228	Drug substance, Drug product	2011-12-01
N202192-002	8415362	2027-12-24		Drug substance, Drug product
N202192-002	10016429	2028-06-12	U-3226		2019-06-12
N202192-002	10016429	2028-06-12	U-3230		2019-06-12
N202192-002	8722693	2028-06-12		Drug substance, Drug product	2014-06-03
N202192-002	8822481	2028-06-12	U-1573		2014-09-24
N202192-002	8822481	2028-06-12	U-3226		2014-09-24
N202192-002	8822481	2028-06-12	U-3227		2014-09-24
N202192-002	8822481	2028-06-12	U-3228		2014-09-24
N202192-002	8822481	2028-06-12	U-3230		2014-09-24
N202192-002	8829013	2028-06-12	U-1201		2014-09-24
N202192-002	8829013	2028-06-12	U-1622		2014-09-24
N202192-002	8829013	2028-06-12	U-3227		2014-09-24
N202192-002	8829013	2028-06-12	U-3228		2014-09-24
N202192-002	7598257*PED	2028-06-24		Pediatric extension
N202192-002	8415362*PED	2028-06-24		Pediatric extension
N202192-002	10016429*PED	2028-12-12		Pediatric extension
N202192-002	8722693*PED	2028-12-12		Pediatric extension
N202192-002	8822481*PED	2028-12-12		Pediatric extension
N202192-002	8829013*PED	2028-12-12		Pediatric extension
N202192-003	9079912	2026-12-12	U-3226		2015-08-04
N202192-003	9079912	2026-12-12	U-3227		2015-08-04
N202192-003	9079912	2026-12-12	U-3228		2015-08-04
N202192-003	9079912	2026-12-12	U-3230		2015-08-04
N202192-003	9814722	2026-12-12	U-3226		2019-06-12
N202192-003	9814722	2026-12-12	U-3230		2019-06-12
N202192-003	9079912*PED	2027-06-12		Pediatric extension
N202192-003	9814722*PED	2027-06-12		Pediatric extension
N202192-003	7598257	2027-12-24	U-3227	Drug substance, Drug product	2011-12-01
N202192-003	7598257	2027-12-24	U-3228	Drug substance, Drug product	2011-12-01
N202192-003	8415362	2027-12-24		Drug substance, Drug product
N202192-003	10016429	2028-06-12	U-3226		2019-06-12
N202192-003	10016429	2028-06-12	U-3230		2019-06-12
N202192-003	8722693	2028-06-12		Drug substance, Drug product	2014-06-03
N202192-003	8822481	2028-06-12	U-1573		2014-09-24
N202192-003	8822481	2028-06-12	U-3226		2014-09-24
N202192-003	8822481	2028-06-12	U-3227		2014-09-24
N202192-003	8822481	2028-06-12	U-3228		2014-09-24
N202192-003	8822481	2028-06-12	U-3230		2014-09-24
N202192-003	8829013	2028-06-12	U-1201		2014-09-24
N202192-003	8829013	2028-06-12	U-1622		2014-09-24
N202192-003	8829013	2028-06-12	U-3227		2014-09-24

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 30 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N202192-001	M-285	2025-12-19
N202192-001	ODE-238	2026-05-24
N202192-001	PED	2026-06-19
N202192-001	PED	2026-11-24
N202192-001	ODE-373	2028-09-22
N202192-001	PED	2029-03-22
N202192-002	M-285	2025-12-19
N202192-002	ODE-238	2026-05-24
N202192-002	PED	2026-06-19
N202192-002	PED	2026-11-24
N202192-002	ODE-373	2028-09-22
N202192-002	PED	2029-03-22
N202192-003	M-285	2025-12-19
N202192-003	ODE-238	2026-05-24
N202192-003	PED	2026-06-19
N202192-003	PED	2026-11-24
N202192-003	ODE-373	2028-09-22
N202192-003	PED	2029-03-22
N202192-004	M-285	2025-12-19
N202192-004	ODE-238	2026-05-24
N202192-004	PED	2026-06-19
N202192-004	PED	2026-11-24
N202192-004	ODE-373	2028-09-22
N202192-004	PED	2029-03-22
N202192-005	M-285	2025-12-19
N202192-005	ODE-238	2026-05-24
N202192-005	PED	2026-06-19
N202192-005	PED	2026-11-24
N202192-005	ODE-373	2028-09-22
N202192-005	PED	2029-03-22

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 6 · 205 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N202192-001	JAKAFI	EQ 5MG BASE	TABLET / ORAL	RLD	2011-11-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202192-002	JAKAFI	EQ 10MG BASE	TABLET / ORAL	RLD	2011-11-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202192-003	JAKAFI	EQ 15MG BASE	TABLET / ORAL	RLD	2011-11-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202192-004	JAKAFI	EQ 20MG BASE	TABLET / ORAL	RLD	2011-11-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202192-005	JAKAFI	EQ 25MG BASE	TABLET / ORAL	RLD, RS	2011-11-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202192-001	JAKAFI	EQ 5MG BASE	TABLET / ORAL	RLD	2011-11-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202192-002	JAKAFI	EQ 10MG BASE	TABLET / ORAL	RLD	2011-11-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202192-003	JAKAFI	EQ 15MG BASE	TABLET / ORAL	RLD	2011-11-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202192-004	JAKAFI	EQ 20MG BASE	TABLET / ORAL	RLD	2011-11-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202192-005	JAKAFI	EQ 25MG BASE	TABLET / ORAL	RLD, RS	2011-11-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N202192-001	JAKAFI	EQ 5MG BASE	TABLET / ORAL	RLD	2011-11-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202192-002	JAKAFI	EQ 10MG BASE	TABLET / ORAL	RLD	2011-11-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202192-003	JAKAFI	EQ 15MG BASE	TABLET / ORAL	RLD	2011-11-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202192-004	JAKAFI	EQ 20MG BASE	TABLET / ORAL	RLD	2011-11-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202192-005	JAKAFI	EQ 25MG BASE	TABLET / ORAL	RLD, RS	2011-11-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202192-001	JAKAFI	EQ 5MG BASE	TABLET / ORAL	RLD	2011-11-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202192-002	JAKAFI	EQ 10MG BASE	TABLET / ORAL	RLD	2011-11-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202192-003	JAKAFI	EQ 15MG BASE	TABLET / ORAL	RLD	2011-11-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202192-004	JAKAFI	EQ 20MG BASE	TABLET / ORAL	RLD	2011-11-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202192-005	JAKAFI	EQ 25MG BASE	TABLET / ORAL	RLD, RS	2011-11-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202192-001	JAKAFI	EQ 5MG BASE	TABLET / ORAL	RLD	2011-11-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202192-002	JAKAFI	EQ 10MG BASE	TABLET / ORAL	RLD	2011-11-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202192-003	JAKAFI	EQ 15MG BASE	TABLET / ORAL	RLD	2011-11-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202192-004	JAKAFI	EQ 20MG BASE	TABLET / ORAL	RLD	2011-11-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202192-005	JAKAFI	EQ 25MG BASE	TABLET / ORAL	RLD, RS	2011-11-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202192-001	JAKAFI	EQ 5MG BASE	TABLET / ORAL	RLD	2011-11-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202192-002	JAKAFI	EQ 10MG BASE	TABLET / ORAL	RLD	2011-11-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202192-003	JAKAFI	EQ 15MG BASE	TABLET / ORAL	RLD	2011-11-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202192-004	JAKAFI	EQ 20MG BASE	TABLET / ORAL	RLD	2011-11-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202192-005	JAKAFI	EQ 25MG BASE	TABLET / ORAL	RLD, RS	2011-11-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202192-001	JAKAFI	EQ 5MG BASE	TABLET / ORAL	RLD	2011-11-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202192-002	JAKAFI	EQ 10MG BASE	TABLET / ORAL	RLD	2011-11-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202192-003	JAKAFI	EQ 15MG BASE	TABLET / ORAL	RLD	2011-11-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202192-004	JAKAFI	EQ 20MG BASE	TABLET / ORAL	RLD	2011-11-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202192-005	JAKAFI	EQ 25MG BASE	TABLET / ORAL	RLD, RS	2011-11-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202192-001	JAKAFI	EQ 5MG BASE	TABLET / ORAL	RLD	2011-11-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202192-002	JAKAFI	EQ 10MG BASE	TABLET / ORAL	RLD	2011-11-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202192-003	JAKAFI	EQ 15MG BASE	TABLET / ORAL	RLD	2011-11-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202192-004	JAKAFI	EQ 20MG BASE	TABLET / ORAL	RLD	2011-11-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202192-005	JAKAFI	EQ 25MG BASE	TABLET / ORAL	RLD, RS	2011-11-16	`5bbf6a4d5a75…`

Observed Orange Book patent history#

Patent history page 1 of 122 · 4,865 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N202192-001	9079912	2026-12-12	U-3226		2015-08-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202192-001	9079912	2026-12-12	U-3228		2015-08-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202192-001	9079912	2026-12-12	U-3227		2015-08-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202192-001	9079912	2026-12-12	U-3230		2015-08-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202192-001	9814722	2026-12-12	U-3226		2019-06-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202192-001	9814722	2026-12-12	U-3230		2019-06-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202192-001	9079912*PED	2027-06-12		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202192-001	9814722*PED	2027-06-12		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202192-001	7598257	2027-12-24	U-3228	Drug substance, Drug product	2011-12-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202192-001	7598257	2027-12-24	U-3227	Drug substance, Drug product	2011-12-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202192-001	8415362	2027-12-24		Drug substance, Drug product	2013-04-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202192-001	10016429	2028-06-12	U-3226		2019-06-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202192-001	10016429	2028-06-12	U-3230		2019-06-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202192-001	8722693	2028-06-12		Drug substance, Drug product	2014-06-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202192-001	8822481	2028-06-12	U-1573		2014-09-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202192-001	8822481	2028-06-12	U-3226		2014-09-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202192-001	8822481	2028-06-12	U-3228		2014-09-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202192-001	8822481	2028-06-12	U-3227		2014-09-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202192-001	8822481	2028-06-12	U-3230		2014-09-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202192-001	8829013	2028-06-12	U-1622		2014-09-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202192-001	8829013	2028-06-12	U-1201		2014-09-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202192-001	8829013	2028-06-12	U-3227		2014-09-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202192-001	8829013	2028-06-12	U-3228		2014-09-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202192-001	7598257*PED	2028-06-24		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202192-001	8415362*PED	2028-06-24		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202192-001	10016429*PED	2028-12-12		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202192-001	8722693*PED	2028-12-12		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202192-001	8822481*PED	2028-12-12		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202192-001	8829013*PED	2028-12-12		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202192-002	9079912	2026-12-12	U-3227		2015-08-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202192-002	9079912	2026-12-12	U-3226		2015-08-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202192-002	9079912	2026-12-12	U-3228		2015-08-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202192-002	9079912	2026-12-12	U-3230		2015-08-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202192-002	9814722	2026-12-12	U-3226		2019-06-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202192-002	9814722	2026-12-12	U-3230		2019-06-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202192-002	9079912*PED	2027-06-12		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202192-002	9814722*PED	2027-06-12		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202192-002	7598257	2027-12-24	U-3228	Drug substance, Drug product	2011-12-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202192-002	7598257	2027-12-24	U-3227	Drug substance, Drug product	2011-12-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202192-002	8415362	2027-12-24		Drug substance, Drug product		`011fe1cb6892…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 27 · 1,076 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N202192-001	M-285	2025-12-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202192-001	ODE-238	2026-05-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202192-001	PED	2026-06-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202192-001	PED	2026-11-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202192-001	ODE-373	2028-09-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202192-001	PED	2029-03-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202192-002	M-285	2025-12-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202192-002	ODE-238	2026-05-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202192-002	PED	2026-06-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202192-002	PED	2026-11-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202192-002	ODE-373	2028-09-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202192-002	PED	2029-03-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202192-003	M-285	2025-12-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202192-003	ODE-238	2026-05-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202192-003	PED	2026-06-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202192-003	PED	2026-11-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202192-003	ODE-373	2028-09-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202192-003	PED	2029-03-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202192-004	M-285	2025-12-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202192-004	ODE-238	2026-05-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202192-004	PED	2026-06-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202192-004	PED	2026-11-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202192-004	ODE-373	2028-09-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202192-004	PED	2029-03-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202192-005	M-285	2025-12-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202192-005	ODE-238	2026-05-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202192-005	PED	2026-06-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202192-005	PED	2026-11-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202192-005	ODE-373	2028-09-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202192-005	PED	2029-03-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202192-001	I-872	2024-09-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202192-001	PED	2025-03-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202192-001	M-285	2025-12-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202192-001	ODE-238	2026-05-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202192-001	PED	2026-06-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202192-001	PED	2026-11-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202192-001	ODE-373	2028-09-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202192-001	PED	2029-03-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202192-002	I-872	2024-09-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202192-002	PED	2025-03-22	`31067a03dcf5…`

Additional Listing Data#

Finished product: Yes
Brand name base: JAKAFI
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
RUXOLITINIB	5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
82S8X8XX8H	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 20 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1193331	Internal RxNorm lookup
1193337	Internal RxNorm lookup
1193339	Internal RxNorm lookup
1193341	Internal RxNorm lookup
1193343	Internal RxNorm lookup
1193345	Internal RxNorm lookup
1193347	Internal RxNorm lookup
1193349	Internal RxNorm lookup
1193351	Internal RxNorm lookup
1193353	Internal RxNorm lookup
2743012	Internal RxNorm lookup
2743016	Internal RxNorm lookup
2743019	Internal RxNorm lookup
2743022	Internal RxNorm lookup
2743025	Internal RxNorm lookup
2743028	Internal RxNorm lookup
2743032	Internal RxNorm lookup
2743035	Internal RxNorm lookup
2743041	Internal RxNorm lookup
2743044	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
f1c82580-87ae-11e0-bc84-0002a5d5c51b	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
54477ffc-bf5d-4583-bcf6-d041bdba36f1	Product name	1	20220316
95a946d8-a784-4eb7-bff4-2194e4331c6f	Product name	1	20190828

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50881-005-60	JAKAFI	60 in 1 BOTTLE, PLASTIC	TABLET	60		40

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50881-005-60	EA - Each	50881-005	089027b8-a5f3-4227-8f4a-14f3a9cf83ae	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
RUXOLITINIB	ACTIVE INGREDIENT	82S8X8XX8H	JAKAFI (RUXOLITINIB) TABLET [INCYTE CORPORATION]	13
RUXOLITINIB	ACTIVE MOIETY	82S8X8XX8H	JAKAFI (RUXOLITINIB) TABLET [INCYTE CORPORATION]	13
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	JAKAFI (RUXOLITINIB) TABLET [INCYTE CORPORATION]	13
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	JAKAFI (RUXOLITINIB) TABLET [INCYTE CORPORATION]	13
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	JAKAFI (RUXOLITINIB) TABLET [INCYTE CORPORATION]	13
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	JAKAFI (RUXOLITINIB) TABLET [INCYTE CORPORATION]	13
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	JAKAFI (RUXOLITINIB) TABLET [INCYTE CORPORATION]	13
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	JAKAFI (RUXOLITINIB) TABLET [INCYTE CORPORATION]	13
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	JAKAFI (RUXOLITINIB) TABLET [INCYTE CORPORATION]	13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50881-005	JAKAFI (RUXOLITINIB) TABLET [INCYTE CORPORATION]	38	Current NDC, Legacy NDC, 1 package rows	20250120_f1c82580-87ae-11e0-bc84-0002a5d5c51b.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
JAKAFI	RUXOLITINIB	Incyte Corporation	f1c82580-87ae-11e0-bc84-0002a5d5c51b	2026-07-20	Warnings, Adverse reactions	Exact identifier application applno (NDA): 202192 application number: NDA202192 ndc (package): 50881-005-60 ndc (product): 50881-005 ndc11 (package): 50881000560

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
82S8X8XX8H	RUXOLITINIB	941678-49-5	RUXOLITINIB

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1193337	Jakafi 10 MG Oral Tablet	PSN	f1c82580-87ae-11e0-bc84-0002a5d5c51b	40
1193345	Jakafi 15 MG Oral Tablet	PSN	f1c82580-87ae-11e0-bc84-0002a5d5c51b	40
1193349	Jakafi 20 MG Oral Tablet	PSN	f1c82580-87ae-11e0-bc84-0002a5d5c51b	40
1193353	Jakafi 25 MG Oral Tablet	PSN	f1c82580-87ae-11e0-bc84-0002a5d5c51b	40
1193341	Jakafi 5 MG Oral Tablet	PSN	f1c82580-87ae-11e0-bc84-0002a5d5c51b	40
2743016	Jakafi XR 11 MG 24HR Extended Release Oral Tablet	PSN	f1c82580-87ae-11e0-bc84-0002a5d5c51b	40
2743022	Jakafi XR 22 MG 24HR Extended Release Oral Tablet	PSN	f1c82580-87ae-11e0-bc84-0002a5d5c51b	40
2743028	Jakafi XR 33 MG 24HR Extended Release Oral Tablet	PSN	f1c82580-87ae-11e0-bc84-0002a5d5c51b	40
2743035	Jakafi XR 44 MG 24HR Extended Release Oral Tablet	PSN	f1c82580-87ae-11e0-bc84-0002a5d5c51b	40
2743044	Jakafi XR 55 MG 24HR Extended Release Oral Tablet	PSN	f1c82580-87ae-11e0-bc84-0002a5d5c51b	40
1193331	ruxolitinib 10 MG Oral Tablet	PSN	f1c82580-87ae-11e0-bc84-0002a5d5c51b	40
2743012	ruxolitinib 11 MG 24HR Extended Release Oral Tablet	PSN	f1c82580-87ae-11e0-bc84-0002a5d5c51b	40
1193343	ruxolitinib 15 MG Oral Tablet	PSN	f1c82580-87ae-11e0-bc84-0002a5d5c51b	40
1193347	ruxolitinib 20 MG Oral Tablet	PSN	f1c82580-87ae-11e0-bc84-0002a5d5c51b	40
2743019	ruxolitinib 22 MG 24HR Extended Release Oral Tablet	PSN	f1c82580-87ae-11e0-bc84-0002a5d5c51b	40
1193351	ruxolitinib 25 MG Oral Tablet	PSN	f1c82580-87ae-11e0-bc84-0002a5d5c51b	40
2743025	ruxolitinib 33 MG 24HR Extended Release Oral Tablet	PSN	f1c82580-87ae-11e0-bc84-0002a5d5c51b	40
2743032	ruxolitinib 44 MG 24HR Extended Release Oral Tablet	PSN	f1c82580-87ae-11e0-bc84-0002a5d5c51b	40
1193339	ruxolitinib 5 MG Oral Tablet	PSN	f1c82580-87ae-11e0-bc84-0002a5d5c51b	40
2743041	ruxolitinib 55 MG 24HR Extended Release Oral Tablet	PSN	f1c82580-87ae-11e0-bc84-0002a5d5c51b	40
2743016	24 HR ruxolitinib 11 MG Extended Release Oral Tablet [Jakafi]	SBD	f1c82580-87ae-11e0-bc84-0002a5d5c51b	40
2743022	24 HR ruxolitinib 22 MG Extended Release Oral Tablet [Jakafi]	SBD	f1c82580-87ae-11e0-bc84-0002a5d5c51b	40
2743028	24 HR ruxolitinib 33 MG Extended Release Oral Tablet [Jakafi]	SBD	f1c82580-87ae-11e0-bc84-0002a5d5c51b	40
2743035	24 HR ruxolitinib 44 MG Extended Release Oral Tablet [Jakafi]	SBD	f1c82580-87ae-11e0-bc84-0002a5d5c51b	40
2743044	24 HR ruxolitinib 55 MG Extended Release Oral Tablet [Jakafi]	SBD	f1c82580-87ae-11e0-bc84-0002a5d5c51b	40
1193337	ruxolitinib 10 MG Oral Tablet [Jakafi]	SBD	f1c82580-87ae-11e0-bc84-0002a5d5c51b	40
1193345	ruxolitinib 15 MG Oral Tablet [Jakafi]	SBD	f1c82580-87ae-11e0-bc84-0002a5d5c51b	40
1193349	ruxolitinib 20 MG Oral Tablet [Jakafi]	SBD	f1c82580-87ae-11e0-bc84-0002a5d5c51b	40
1193353	ruxolitinib 25 MG Oral Tablet [Jakafi]	SBD	f1c82580-87ae-11e0-bc84-0002a5d5c51b	40
1193341	ruxolitinib 5 MG Oral Tablet [Jakafi]	SBD	f1c82580-87ae-11e0-bc84-0002a5d5c51b	40
2743012	24 HR ruxolitinib 11 MG Extended Release Oral Tablet	SCD	f1c82580-87ae-11e0-bc84-0002a5d5c51b	40
2743019	24 HR ruxolitinib 22 MG Extended Release Oral Tablet	SCD	f1c82580-87ae-11e0-bc84-0002a5d5c51b	40
2743025	24 HR ruxolitinib 33 MG Extended Release Oral Tablet	SCD	f1c82580-87ae-11e0-bc84-0002a5d5c51b	40
2743032	24 HR ruxolitinib 44 MG Extended Release Oral Tablet	SCD	f1c82580-87ae-11e0-bc84-0002a5d5c51b	40
2743041	24 HR ruxolitinib 55 MG Extended Release Oral Tablet	SCD	f1c82580-87ae-11e0-bc84-0002a5d5c51b	40
1193331	ruxolitinib 10 MG Oral Tablet	SCD	f1c82580-87ae-11e0-bc84-0002a5d5c51b	40
1193343	ruxolitinib 15 MG Oral Tablet	SCD	f1c82580-87ae-11e0-bc84-0002a5d5c51b	40
1193347	ruxolitinib 20 MG Oral Tablet	SCD	f1c82580-87ae-11e0-bc84-0002a5d5c51b	40
1193351	ruxolitinib 25 MG Oral Tablet	SCD	f1c82580-87ae-11e0-bc84-0002a5d5c51b	40
1193339	ruxolitinib 5 MG Oral Tablet	SCD	f1c82580-87ae-11e0-bc84-0002a5d5c51b	40
1193337	Jakafi (as ruxolitinib phosphate) 10 MG Oral Tablet	SY	f1c82580-87ae-11e0-bc84-0002a5d5c51b	40
1193337	Jakafi 10 MG Oral Tablet	SY	f1c82580-87ae-11e0-bc84-0002a5d5c51b	40
1193345	Jakafi 15 MG Oral Tablet	SY	f1c82580-87ae-11e0-bc84-0002a5d5c51b	40
1193349	Jakafi 20 MG Oral Tablet	SY	f1c82580-87ae-11e0-bc84-0002a5d5c51b	40
1193353	Jakafi 25 MG Oral Tablet	SY	f1c82580-87ae-11e0-bc84-0002a5d5c51b	40
1193341	Jakafi 5 MG Oral Tablet	SY	f1c82580-87ae-11e0-bc84-0002a5d5c51b	40
2743016	Jakafi XR 11 MG 24 HR Extended Release Oral Tablet	SY	f1c82580-87ae-11e0-bc84-0002a5d5c51b	40
2743022	Jakafi XR 22 MG 24 HR Extended Release Oral Tablet	SY	f1c82580-87ae-11e0-bc84-0002a5d5c51b	40
2743028	Jakafi XR 33 MG 24 HR Extended Release Oral Tablet	SY	f1c82580-87ae-11e0-bc84-0002a5d5c51b	40
2743035	Jakafi XR 44 MG 24 HR Extended Release Oral Tablet	SY	f1c82580-87ae-11e0-bc84-0002a5d5c51b	40
2743044	Jakafi XR 55 MG 24 HR Extended Release Oral Tablet	SY	f1c82580-87ae-11e0-bc84-0002a5d5c51b	40
1193331	ruxolitinib (as ruxolitinib phosphate) 10 MG Oral Tablet	SY	f1c82580-87ae-11e0-bc84-0002a5d5c51b	40
1193343	ruxolitinib (as ruxolitinib phosphate) 15 MG Oral Tablet	SY	f1c82580-87ae-11e0-bc84-0002a5d5c51b	40
1193347	ruxolitinib (as ruxolitinib phosphate) 20 MG Oral Tablet	SY	f1c82580-87ae-11e0-bc84-0002a5d5c51b	40
1193351	ruxolitinib (as ruxolitinib phosphate) 25 MG Oral Tablet	SY	f1c82580-87ae-11e0-bc84-0002a5d5c51b	40
1193339	ruxolitinib (as ruxolitinib phosphate) 5 MG Oral Tablet	SY	f1c82580-87ae-11e0-bc84-0002a5d5c51b	40
2743012	ruxolitinib 11 MG 24 HR Extended Release Oral Tablet	SY	f1c82580-87ae-11e0-bc84-0002a5d5c51b	40
2743019	ruxolitinib 22 MG 24 HR Extended Release Oral Tablet	SY	f1c82580-87ae-11e0-bc84-0002a5d5c51b	40
2743025	ruxolitinib 33 MG 24 HR Extended Release Oral Tablet	SY	f1c82580-87ae-11e0-bc84-0002a5d5c51b	40
2743032	ruxolitinib 44 MG 24 HR Extended Release Oral Tablet	SY	f1c82580-87ae-11e0-bc84-0002a5d5c51b	40
2743041	ruxolitinib 55 MG 24 HR Extended Release Oral Tablet	SY	f1c82580-87ae-11e0-bc84-0002a5d5c51b	40

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50881-005-60	50881000560	60 TABLET in 1 BOTTLE, PLASTIC (50881-005-60)	60 tablet	2011-11-16	0000-00-00	No	No	Current