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United States · US · US:72694-728_a5229004-7c72-421b-a4ea-2830ee872d20

VORANIGO

Orange BookUNIISPLATC L01XM04

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

Identification

ManufacturerServier Pharmaceuticals LLC
CountryUS (United States)
ATC codeL01XM04
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7269472840
    1 BOTTLE in 1 CARTON (72694-728-40) / 30 TABLET, FILM COATED in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
789Q85GA8P
VORASIDENIB
Orange Book
N218784
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "789Q85GA8P",
    "rxcui": null,
    "inchikey": "QCZAWDGAVJMPTA-RNFRBKRXSA-N",
    "display_name": "VORASIDENIB",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "31405fee-55b7-4857-987e-2724ee76be84": {
      "match": "brand_token",
      "title": "VORANIGO (VORASIDENIB) TABLET, FILM COATED [SERVIER PHARMACEUTICALS LLC]",
      "spl_version": "4",
      "published_date": "2025-04-10"
    }
  },
  "productid": "72694-728_a5229004-7c72-421b-a4ea-2830ee872d20",
  "productndc": "72694-728",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "218784",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "10MG",
        "product_no": "001",
        "approval_date": "Aug 6, 2024"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "40MG",
        "product_no": "002",
        "approval_date": "Aug 6, 2024"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "VORASIDENIB",
  "proprietary_name": "VORANIGO",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA218784",
  "marketing_category": "NDA",
  "nonproprietary_name": "vorasidenib",
  "start_marketing_date": "20240807",
  "active_numerator_strength": "40"
}

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