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United States · US · US:63323-117_e1f73bef-26d8-419c-96c1-a8f8aa201c63

Fluorouracil

Orange BookUNIISPLATC L01BC02

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

Identification

ManufacturerFresenius Kabi USA, LLC
CountryUS (United States)
ATC codeL01BC02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    6332311751
    1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (63323-117-51) / 50 mL in 1 VIAL, PHARMACY BULK PACKAGE
  • ndc11
    6332311761
    1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (63323-117-61) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE

Annotations

UNII (FDA Substance ID)
U3P01618RT
FLUOROURACIL
RxCUI 4492
Orange Book
A040278
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": "63323-117_e1f73bef-26d8-419c-96c1-a8f8aa201c63",
  "productndc": "63323-117",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "040278",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "2.5GM/50ML (50MG/ML)",
        "product_no": "001",
        "approval_date": "Sep 30, 1998"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AP",
        "strength": "5GM/100ML (50MG/ML)",
        "product_no": "002",
        "approval_date": "Sep 30, 1998"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "FLUOROURACIL",
  "proprietary_name": "Fluorouracil",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA040278",
  "marketing_category": "ANDA",
  "nonproprietary_name": "FLUOROURACIL",
  "start_marketing_date": "20000712",
  "active_numerator_strength": "50"
}

Related drugs

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