leqselvi

Generic: deuruxolitinib phosphate

Labeler: sun pharmaceutical industries, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name leqselvi
Generic Name deuruxolitinib phosphate
Labeler sun pharmaceutical industries, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

deuruxolitinib phosphate 8 mg/1

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 47335-108
Product ID 47335-108_583fc0b7-67b8-48f2-8d31-127a5f370096
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA217900
Listing Expiration 2026-12-31
Marketing Start 2025-06-25

Pharmacologic Class

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]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 47335108
Hyphenated Format 47335-108

Supplemental Identifiers

RxCUI
2716563 2716569
UPC
0347335108866
UNII
8VJ43S4LCM

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name leqselvi (source: ndc)
Generic Name deuruxolitinib phosphate (source: ndc)
Application Number NDA217900 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 8 mg/1
source: ndc
Packaging
  • 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (47335-108-86)
source: ndc

Packages (1)

47335-108-86 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (47335-108-86)

Ingredients (1)

deuruxolitinib phosphate (8 mg/1)

Linked Drug Pages (1)

LEQSELVI ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "583fc0b7-67b8-48f2-8d31-127a5f370096", "openfda": {"upc": ["0347335108866"], "unii": ["8VJ43S4LCM"], "rxcui": ["2716563", "2716569"], "spl_set_id": ["a603f231-d09e-4bad-ad5e-b55f865da095"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (47335-108-86)", "package_ndc": "47335-108-86", "marketing_start_date": "20250625"}], "brand_name": "LEQSELVI", "product_id": "47335-108_583fc0b7-67b8-48f2-8d31-127a5f370096", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["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]"], "product_ndc": "47335-108", "generic_name": "deuruxolitinib phosphate", "labeler_name": "Sun Pharmaceutical Industries, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "LEQSELVI", "active_ingredients": [{"name": "DEURUXOLITINIB PHOSPHATE", "strength": "8 mg/1"}], "application_number": "NDA217900", "marketing_category": "NDA", "marketing_start_date": "20250625", "listing_expiration_date": "20261231"}