FLUOROURACIL

Orange BookUNIISPLATC L01BC02

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

Identification

ManufacturerEugia US LLC

CountryUS (United States)

ATC codeL01BC02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5515049801
1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (55150-498-01) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE

Annotations

UNII (FDA Substance ID)

U3P01618RT

FLUOROURACIL

RxCUI 4492

Orange Book

A202669

APAP

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": {
    "beb8c6c5-4b6e-4770-b6d4-718e33c7a2ff": {
      "match": "brand_token",
      "title": "FLUOROURACIL INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]",
      "spl_version": "6",
      "published_date": "2026-04-20"
    }
  },
  "productid": "55150-498_692008d1-c9e5-40d2-a935-cd49e0cb95e5",
  "productndc": "55150-498",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "202669",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "2.5GM/50ML (50MG/ML)",
        "product_no": "001",
        "approval_date": "Jul 17, 2012"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "5GM/100ML (50MG/ML)",
        "product_no": "002",
        "approval_date": "Jul 17, 2012"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "FLUOROURACIL",
  "proprietary_name": "FLUOROURACIL",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA202669",
  "marketing_category": "ANDA",
  "nonproprietary_name": "FLUOROURACIL",
  "start_marketing_date": "20220408",
  "active_numerator_strength": "50"
}

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