Home NDC 47335-108 LEQSELVI
Product NDC 47335-108
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 44 .
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 2026-10-15 13:18:30 2026-09 N217900-001 LEQSELVI EQ 8MG BASE TABLET / ORAL RLD, RS 2024-07-25 c2088c7a36db…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 · 61 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-10-15 13:18:30 2026-09 N217900-001 10561659 2037-05-04 U-3976 2024-08-23 c2088c7a36db…2026-10-15 13:18:30 2026-09 N217900-001 12076323 2037-05-04 U-3976 2024-10-01 c2088c7a36db…2026-10-15 13:18:30 2026-09 N217900-001 11919907 2041-05-21 U-3976 Drug product 2024-08-23 c2088c7a36db…2026-10-15 13:18:30 2026-09 N217900-001 12285432 2042-08-11 U-3976 2025-05-29 c2088c7a36db…2026-10-15 13:18:30 2026-09 N217900-001 12247034 2044-05-10 Drug substance, Drug product 2025-04-08 c2088c7a36db…2026-10-15 13:18:30 2026-09 N217900-001 12364699 2044-10-10 U-3976 2025-08-21 c2088c7a36db…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…
Observed Orange Book exclusivity history# 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# 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 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