FAVLYXA

Orange BookUNIISPLATC L01BC02

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerAvyxa Pharma, LLC

CountryUS (United States)

ATC codeL01BC02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
8383114301
1 VIAL, SINGLE-DOSE in 1 CARTON (83831-143-01) / 10 mL in 1 VIAL, SINGLE-DOSE

Annotations

UNII (FDA Substance ID)

U3P01618RT

FLUOROURACIL

RxCUI 4492

Orange Book

N220201

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "U3P01618RT",
    "rxcui": "4492",
    "inchikey": "GHASVSINZRGABV-UHFFFAOYSA-N",
    "display_name": "FLUOROURACIL",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "1daf714b-704c-4bcc-b6e0-6f0eb2bfe66b": {
      "match": "brand_token",
      "title": "FAVLYXA (FLUOROURACIL) INJECTION, SOLUTION [AVYXA PHARMA, LLC]",
      "spl_version": "2",
      "published_date": "2026-04-02"
    }
  },
  "productid": "83831-143_c8c3a5e0-277e-4d3e-910c-62cbc241cc3a",
  "productndc": "83831-143",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "220201",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "250MG/10ML (25MG/ML)",
        "product_no": "001",
        "approval_date": "Feb 20, 2026"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "FLUOROURACIL",
  "proprietary_name": "FAVLYXA",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA220201",
  "marketing_category": "NDA",
  "nonproprietary_name": "Fluorouracil",
  "start_marketing_date": "20260401",
  "active_numerator_strength": "25"
}

Related drugs

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