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United States · US · US:0469-2660_462f0a23-98d6-4154-b113-322008069743

VEOZAH

Orange BookUNIISPLATC G02CX06

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

Identification

ManufacturerAstellas Pharma US, Inc.
CountryUS (United States)
ATC codeG02CX06
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    0469266030
    1 BOTTLE in 1 CARTON (0469-2660-30) / 30 TABLET, FILM COATED in 1 BOTTLE
  • ndc11
    0469266090
    1 BOTTLE in 1 CARTON (0469-2660-90) / 90 TABLET, FILM COATED in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
83VNE45KXX
FEZOLINETANT
Orange Book
N216578
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "83VNE45KXX",
    "rxcui": null,
    "inchikey": "PPSNFPASKFYPMN-SECBINFHSA-N",
    "display_name": "FEZOLINETANT",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "cae9f798-24f9-4580-a4fc-e6c710cbda3c": {
      "match": "brand_token",
      "title": "VEOZAH (FEZOLINETANT) TABLET, FILM COATED [ASTELLAS PHARMA US, INC.]",
      "spl_version": "8",
      "published_date": "2026-03-06"
    }
  },
  "productid": "0469-2660_462f0a23-98d6-4154-b113-322008069743",
  "productndc": "0469-2660",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "216578",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "45MG",
        "product_no": "001",
        "approval_date": "May 12, 2023"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "FEZOLINETANT",
  "proprietary_name": "VEOZAH",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA216578",
  "marketing_category": "NDA",
  "nonproprietary_name": "fezolinetant",
  "start_marketing_date": "20230512",
  "active_numerator_strength": "45"
}

Related drugs

Other records sharing ATC code G02CX06.

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