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United States · US · US:47335-108_583fc0b7-67b8-48f2-8d31-127a5f370096

LEQSELVI

Orange BookUNIISPLATC L04AF

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerSun Pharmaceutical Industries, Inc.
CountryUS (United States)
ATC codeL04AF
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    4733510886
    60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (47335-108-86)

Annotations

UNII (FDA Substance ID)
8VJ43S4LCM
DEURUXOLITINIB PHOSPHATE
Orange Book
N217900
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "8VJ43S4LCM",
    "rxcui": null,
    "inchikey": "JFMWPOCYMYGEDM-NTVOUFPTSA-N",
    "display_name": "DEURUXOLITINIB PHOSPHATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "a603f231-d09e-4bad-ad5e-b55f865da095": {
      "match": "brand_token",
      "title": "LEQSELVI (DEURUXOLITINIB PHOSPHATE) TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]",
      "spl_version": "11",
      "published_date": "2025-07-23"
    }
  },
  "productid": "47335-108_583fc0b7-67b8-48f2-8d31-127a5f370096",
  "productndc": "47335-108",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "217900",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 8MG BASE",
        "product_no": "001",
        "approval_date": "Jul 25, 2024"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DEURUXOLITINIB PHOSPHATE",
  "proprietary_name": "LEQSELVI",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA217900",
  "marketing_category": "NDA",
  "nonproprietary_name": "deuruxolitinib phosphate",
  "start_marketing_date": "20250625",
  "active_numerator_strength": "8"
}

Related drugs

Other records sharing ATC code L04AF.

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