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United States · US · US:73555-501_76183831-b710-4be2-a6a7-9349dd501830

Revuforj

Orange BookUNIISPLATC L01XX

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

Identification

ManufacturerSyndax Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeL01XX
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7355550100
    30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (73555-501-00)

Annotations

UNII (FDA Substance ID)
YL4RYN734D
REVUMENIB CITRATE
Orange Book
N218944
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "YL4RYN734D",
    "rxcui": null,
    "inchikey": "UBXFWTFPYATLBT-SGBGZXBGSA-N",
    "display_name": "REVUMENIB CITRATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "6eb3cdbc-0e74-477d-82d6-3bb172d3f63f": {
      "match": "brand_token",
      "title": "REVUFORJ (REVUMENIB) TABLET, FILM COATED [SYNDAX PHARMACEUTICALS, INC.]",
      "spl_version": "5",
      "published_date": "2026-02-20"
    }
  },
  "productid": "73555-501_76183831-b710-4be2-a6a7-9349dd501830",
  "productndc": "73555-501",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "218944",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 25MG BASE",
        "product_no": "001",
        "approval_date": "Nov 15, 2024"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 110MG BASE",
        "product_no": "002",
        "approval_date": "Nov 15, 2024"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 160MG BASE",
        "product_no": "003",
        "approval_date": "Nov 15, 2024"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "REVUMENIB CITRATE",
  "proprietary_name": "Revuforj",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA218944",
  "marketing_category": "NDA",
  "nonproprietary_name": "revumenib",
  "start_marketing_date": "20241115",
  "active_numerator_strength": "110"
}

Related drugs

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