Home NDC 47335-108 LEQSELVI
Product NDC 47335-108
11-digit product format 473350108
Labeler code 47335
Product ID 47335-108_583fc0b7-67b8-48f2-8d31-127a5f370096
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 2026-12-31
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 · 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 Product TE source text RLD / RS Approval date Source SHA-256 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 · 43 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 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…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N217900-001 11919907 2041-05-21 U-3976 Drug product 2024-08-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N217900-001 10561659 2037-05-04 U-3976 2024-08-23 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N217900-001 11919907 2041-05-21 U-3976 Drug product 2024-08-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N217900-001 10561659 2037-05-04 U-3976 2024-08-23 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N217900-001 12076323 2037-05-04 U-3976 2024-10-01 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N217900-001 11919907 2041-05-21 U-3976 Drug product 2024-08-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N217900-001 10561659 2037-05-04 U-3976 2024-08-23 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N217900-001 12076323 2037-05-04 U-3976 2024-10-01 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N217900-001 11919907 2041-05-21 U-3976 Drug product 2024-08-23 d06236e962d9…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N217900-001 10561659 2037-05-04 U-3976 2024-08-23 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N217900-001 12076323 2037-05-04 U-3976 2024-10-01 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N217900-001 11919907 2041-05-21 U-3976 Drug product 2024-08-23 a50c72e98297…
Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 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…
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
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 8VJ43S4LCM Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2716563 Internal RxNorm lookup 2716569 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# 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
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 (product): 47335-108
DailyMed RxNorm Mappings# 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