LEQSELVI

Product NDC: 47335-108
Requested package NDC: 47335-108-86
11-digit product format: 473350108
Labeler code: 47335
Product ID: 47335-108_4f69c6c1-ae0d-4119-9d3a-53986983f840
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: deuruxolitinib phosphate
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Sun Pharmaceutical Industries, Inc.
Application: NDA217900
Marketing category: NDA
Marketing start: 2025-06-25
Substance: DEURUXOLITINIB PHOSPHATE
Active strength: 8 mg/1
Pharmacologic classes: Bile Salt Export Pump Inhibitors [MoA], Breast Cancer Resistance Protein Inhibitors [MoA], Janus Kinase Inhibitor [EPC], Janus Kinase Inhibitors [MoA], Multidrug and Toxin Extrusion Transporter 2 K Inhibitors [MoA], Organic Anion Transporter 3 Inhibitors [MoA]
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 43.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N217900-001	LEQSELVI	DEURUXOLITINIB PHOSPHATE	EQ 8MG BASE	TABLET / ORAL		RLD, RS	2024-07-25

Orange Book patents#

Current patent rows page 1 of 1 · 6 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N217900-001	10561659	2037-05-04	U-3976		2024-08-23
N217900-001	12076323	2037-05-04	U-3976		2024-10-01
N217900-001	11919907	2041-05-21	U-3976	Drug product	2024-08-23
N217900-001	12285432	2042-08-11	U-3976		2025-05-29
N217900-001	12247034	2044-05-10		Drug substance, Drug product	2025-04-08
N217900-001	12364699	2044-10-10	U-3976		2025-08-21

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N217900-001	NCE	2029-07-25

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N217900-001	LEQSELVI	EQ 8MG BASE	TABLET / ORAL	RLD, RS	2024-07-25	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N217900-001	LEQSELVI	EQ 8MG BASE	TABLET / ORAL	RLD, RS	2024-07-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N217900-001	LEQSELVI	EQ 8MG BASE	TABLET / ORAL	RLD, RS	2024-07-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217900-001	LEQSELVI	EQ 8MG BASE	TABLET / ORAL	RLD, RS	2024-07-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N217900-001	LEQSELVI	EQ 8MG BASE	TABLET / ORAL	RLD, RS	2024-07-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217900-001	LEQSELVI	EQ 8MG BASE	TABLET / ORAL	RLD, RS	2024-07-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N217900-001	LEQSELVI	EQ 8MG BASE	TABLET / ORAL	RLD, RS	2024-07-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N217900-001	LEQSELVI	EQ 8MG BASE	TABLET / ORAL	RLD, RS	2024-07-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N217900-001	LEQSELVI	EQ 8MG BASE	TABLET / ORAL	RLD, RS	2024-07-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N217900-001	LEQSELVI	EQ 8MG BASE	TABLET / ORAL	RLD, RS	2024-07-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N217900-001	LEQSELVI	EQ 8MG BASE	TABLET / ORAL	RLD, RS	2024-07-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N217900-001	LEQSELVI	EQ 8MG BASE	TABLET / ORAL	RLD, RS	2024-07-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N217900-001	LEQSELVI	EQ 8MG BASE	TABLET / ORAL	RLD, RS	2024-07-25	`79d66fd596c7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N217900-001	LEQSELVI	EQ 8MG BASE	TABLET / ORAL	RLD, RS	2024-07-25	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 55 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N217900-001	10561659	2037-05-04	U-3976		2024-08-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217900-001	12076323	2037-05-04	U-3976		2024-10-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217900-001	11919907	2041-05-21	U-3976	Drug product	2024-08-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217900-001	12285432	2042-08-11	U-3976		2025-05-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217900-001	12247034	2044-05-10		Drug substance, Drug product	2025-04-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217900-001	12364699	2044-10-10	U-3976		2025-08-21	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N217900-001	10561659	2037-05-04	U-3976		2024-08-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217900-001	12076323	2037-05-04	U-3976		2024-10-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217900-001	11919907	2041-05-21	U-3976	Drug product	2024-08-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217900-001	12285432	2042-08-11	U-3976		2025-05-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217900-001	12247034	2044-05-10		Drug substance, Drug product	2025-04-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217900-001	12364699	2044-10-10	U-3976		2025-08-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N217900-001	10561659	2037-05-04	U-3976		2024-08-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217900-001	12076323	2037-05-04	U-3976		2024-10-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217900-001	11919907	2041-05-21	U-3976	Drug product	2024-08-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217900-001	12285432	2042-08-11	U-3976		2025-05-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217900-001	12247034	2044-05-10		Drug substance, Drug product	2025-04-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217900-001	12364699	2044-10-10	U-3976		2025-08-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217900-001	10561659	2037-05-04	U-3976		2024-08-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217900-001	12076323	2037-05-04	U-3976		2024-10-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217900-001	11919907	2041-05-21	U-3976	Drug product	2024-08-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217900-001	12285432	2042-08-11	U-3976		2025-05-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217900-001	12247034	2044-05-10		Drug substance, Drug product	2025-04-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217900-001	12364699	2044-10-10	U-3976		2025-08-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N217900-001	10561659	2037-05-04	U-3976		2024-08-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N217900-001	12076323	2037-05-04	U-3976		2024-10-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N217900-001	11919907	2041-05-21	U-3976	Drug product	2024-08-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N217900-001	12285432	2042-08-11	U-3976		2025-05-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N217900-001	12247034	2044-05-10		Drug substance, Drug product	2025-04-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217900-001	10561659	2037-05-04	U-3976		2024-08-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217900-001	12076323	2037-05-04	U-3976		2024-10-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217900-001	11919907	2041-05-21	U-3976	Drug product	2024-08-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N217900-001	10561659	2037-05-04	U-3976		2024-08-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N217900-001	12076323	2037-05-04	U-3976		2024-10-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N217900-001	11919907	2041-05-21	U-3976	Drug product	2024-08-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N217900-001	10561659	2037-05-04	U-3976		2024-08-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N217900-001	12076323	2037-05-04	U-3976		2024-10-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N217900-001	11919907	2041-05-21	U-3976	Drug product	2024-08-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N217900-001	10561659	2037-05-04	U-3976		2024-08-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N217900-001	12076323	2037-05-04	U-3976		2024-10-01	`2680178bc6a6…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-09-14 22:38:34	2026-08	N217900-001	NCE	2029-07-25	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N217900-001	NCE	2029-07-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N217900-001	NCE	2029-07-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217900-001	NCE	2029-07-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N217900-001	NCE	2029-07-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217900-001	NCE	2029-07-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N217900-001	NCE	2029-07-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N217900-001	NCE	2029-07-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N217900-001	NCE	2029-07-25	`2680178bc6a6…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N217900-001	NCE	2029-07-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N217900-001	NCE	2029-07-25	`d06236e962d9…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N217900-001	NCE	2029-07-25	`a50c72e98297…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DEURUXOLITINIB PHOSPHATE	8 mg/1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
fdf2b747-6482-45b8-968f-e0b7c1f8652b	Product name	1	20250307

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
47335-108-86	LEQSELVI	60 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	60		11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
47335-108-86	EA - Each	47335-108	23a530f5-6270-4574-a24c-e916a5831a73	1	2025-06-13

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
LEQSELVI	DEURUXOLITINIB PHOSPHATE	Sun Pharmaceutical Industries, Inc.	a603f231-d09e-4bad-ad5e-b55f865da095	2026-07-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 217900 application number: NDA217900 ndc (package): 47335-108-86 ndc (product): 47335-108 ndc11 (package): 47335010886

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2716563	deuruxolitinib 8 MG Oral Tablet	PSN	a603f231-d09e-4bad-ad5e-b55f865da095	11
2716569	LEQSELVI 8 MG Oral Tablet	PSN	a603f231-d09e-4bad-ad5e-b55f865da095	11
2716569	deuruxolitinib 8 MG Oral Tablet [Leqselvi]	SBD	a603f231-d09e-4bad-ad5e-b55f865da095	11
2716563	deuruxolitinib 8 MG Oral Tablet	SCD	a603f231-d09e-4bad-ad5e-b55f865da095	11
2716569	Leqselvi 8 MG Oral Tablet	SY	a603f231-d09e-4bad-ad5e-b55f865da095	11

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
47335-108-86	47335010886	60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (47335-108-86)	2025-06-25	No	No	Current