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 Additional Listing Data#
Finished product Yes
Brand name base LEQSELVI
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DEURUXOLITINIB PHOSPHATE 8 mg/1
Harmonized Identifiers# Field, Values table Field Values Unii 8VJ43S4LCM Rxcui 2716563, 2716569
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 Historical