Fluorouracil

Orange BookUNIISPLATC L01BC02

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

Identification

ManufacturerAlembic Pharmaceuticals Limited

CountryUS (United States)

ATC codeL01BC02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
4670875150
1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (46708-751-50) / 50 mL in 1 VIAL, PHARMACY BULK PACKAGE

Annotations

UNII (FDA Substance ID)

U3P01618RT

FLUOROURACIL

RxCUI 4492

Orange Book

A217295

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": "46708-751_d10f12a2-7b38-4351-93df-1e8444d2a9e4",
  "productndc": "46708-751",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "217295",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AP",
        "strength": "2.5GM/50ML (50MG/ML)",
        "product_no": "001",
        "approval_date": "Mar 3, 2023"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "FLUOROURACIL",
  "proprietary_name": "Fluorouracil",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA217295",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Fluorouracil",
  "start_marketing_date": "20230303",
  "active_numerator_strength": "50"
}

Related drugs

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