JAKAFI

Product NDC: 50881-015
11-digit product format: 508810015
Labeler code: 50881
Product ID: 50881-015_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: 15 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

Orange Book products#

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#

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

Orange Book exclusivity#

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

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

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

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings and cautions

5 WARNINGS AND PRECAUTIONS Thrombocytopenia, Anemia, and Neutropenia: Manage by dose reduction or interruption, or transfusion. ( 5.1 ) Risk of Infection: Assess patients for signs and symptoms of infection and initiate appropriate treatment promptly. Serious infections should have resolved before starting therapy with JAKAFI/JAKAFI XR. ( 5.2 ) Symptom Exacerbation Following Interruption or Discontinuation: Manage with supportive care and consider resuming treatment with JAKAFI/JAKAFI XR. ( 5.3 ) Risk of Non-Melanoma Skin Cancer: Perform periodic skin examinations. ( 5.4 ) Lipid Elevations: Assess lipid levels 8 to 12 weeks from start of therapy and treat as needed. ( 5.5 ) Major Adverse Cardiovascular Events (MACE): Monitor for development of MACE. ( 5.6 ) Thrombosis: Evaluate and treat symptoms of thrombosis promptly. ( 5.7 ) Secondary Malignancies: Monitor for development of secondary malignancies, particularly in patients who are current or past smokers. ( 5.8 ) 5.1 Thrombocytopenia, Anemia, and Neutropenia Treatment with JAKAFI/JAKAFI XR can cause thrombocytopenia, anemia, and neutropenia [ see Adverse Reactions ( 6.1 )] . Manage thrombocytopenia by reducing the dose or temporarily interrupting JAKAFI/JAKAFI XR. Platelet transfusions may be necessary [ see Dosage and Administration ( 2 ) ] . Patients developing anemia may require blood transfusions and/or dose modifications of JAKAFI/JAKAFI XR. Severe neutropenia (ANC less than 0.5 × 10 9 /L) was generally reversible by withholding JAKAFI/JAKAFI XR until recovery. Perform a pre-treatment CBC and monitor CBCs every 2 to 4 weeks until doses are stabilized, and then as clinically indicated [ see Dosage and Administration ( 2 )] . 5.2 Risk of Infection Serious bacterial, mycobacterial, fungal, and viral infections have occurred [ see Adverse Reactions ( 6.1 )] . Delay starting therapy with JAKAFI/JAKAFI XR until active serious infections have resolved. Observe patients receiving JAKAFI/JAKAFI XR for signs and symptoms of infection and manage promptly. Use active surveillance and prophylactic antibiotics according to clinical guidelines. Tuberculosis Tuberculosis infection has been reported in patients receiving JAKAFI. Observe patients receiving JAKAFI/JAKAFI XR for signs and symptoms of active tuberculosis and manage promptly. Prior to initiating JAKAFI/JAKAFI XR, patients should be evaluated for tuberc...

Adverse reactions cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

adverse reactions

6 ADVERSE REACTIONS The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling: Thrombocytopenia, Anemia and Neutropenia [see Warnings and Precautions ( 5.1 )] Risk of Infection [see Warnings and Precautions ( 5.2 )] Symptom Exacerbation Following Interruption or Discontinuation of Treatment [see Warnings and Precautions ( 5.3 )] Non-Melanoma Skin Cancer [see Warnings and Precautions ( 5.4 )] Lipid Elevations [ see Warnings and Precautions ( 5.5 )] Major Adverse Cardiovascular Events (MACE) [ see Warnings and Precautions ( 5.6 )] Thrombosis [ see Warnings and Precautions ( 5.7 )] Secondary Malignancies [ see Warnings and Precautions ( 5.8 )] In myelofibrosis and polycythemia vera, the most common hematologic adverse reactions (incidence > 20%) are thrombocytopenia and anemia. The most common nonhematologic adverse reactions (incidence ≥ 15%) are bruising, dizziness, headache, and diarrhea. ( 6.1 ) In acute graft-versus-host disease, the most common hematologic adverse reactions (incidence > 50%) are anemia, thrombocytopenia, and neutropenia. The most common nonhematologic adverse reactions (incidence > 50%) are infections (pathogen not specified) and edema. ( 6.1 ) In chronic graft-versus-host disease, the most common hematologic adverse reactions (incidence > 35%) are anemia and thrombocytopenia. The most common nonhematologic adverse reactions (incidence ≥ 20%) are infections (pathogen not specified) and viral infections. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Incyte Corporation at 1-855-463-3463 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of JAKAFI XR has been established from adequate and well-controlled studies of JAKAFI in adult patients with myelofibrosis, polycythemia vera, and adult and pediatric patients with acute and chronic graft-versus-host-disease [see Clinical Studies ( 14 )] . Below is a display of the adverse reactions of JAKAFI in these adequate and well-controlled studies. Myelofibrosis The safety of JAKAFI was assessed in 617 patients in 6 clinical stud...

adverse reactions table

Table 15: Myelofibrosis: Nonhematologic Adverse Reactions Occurring in Patients on JAKAFI in the Double-Blind, Placebo-Controlled Study During Randomized Treatment JAKAFI (N = 155)Placebo (N = 151) Adverse ReactionsAll GradesNational Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 3.0. (%)Grade 3 (%)Grade 4 (%)All Grades (%)Grade 3 (%)Grade 4 (%) BruisingIncludes contusion, ecchymosis, hematoma, injection site hematoma, periorbital hematoma, vessel puncture site hematoma, increased tendency to bruise, petechiae, purpura. 23< 101500 DizzinessIncludes dizziness, postural dizziness, vertigo, balance disorder, Meniere’s Disease, labyrinthitis. 18< 10700 Headache1500500 Urinary Tract InfectionsIncludes urinary tract infection, cystitis, urosepsis, urinary tract infection bacterial, kidney infection, pyuria, bacteria urine, bacteria urine identified, nitrite urine present. 9005< 1< 1 Weight GainIncludes weight increased, abnormal weight gain. 7< 101< 10 Flatulence500< 100 Herpes ZosterIncludes herpes zoster and post-herpetic neuralgia. 200< 100

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
RUXOLITINIB	15 mg/1

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
50881-015-60	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
50881-015-60	EA - Each	50881-015	58d5d3ab-9d0e-47b9-a46e-0f842f32a0f3	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
50881-015	JAKAFI (RUXOLITINIB) TABLET [INCYTE CORPORATION]	38	Current NDC, Legacy NDC, 1 package rows	20250120_f1c82580-87ae-11e0-bc84-0002a5d5c51b.zip

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
50881-015-60	50881001560	60 TABLET in 1 BOTTLE, PLASTIC (50881-015-60)	60 tablet	2011-11-16	0000-00-00	No	No	Current