Fluorouracil

Orange BookUNIISPLATC L01BC02

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

Identification

ManufacturerMeitheal Pharmaceuticals Inc.

CountryUS (United States)

ATC codeL01BC02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7128817075
1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (71288-170-75) / 50 mL in 1 VIAL, PHARMACY BULK PACKAGE

Annotations

UNII (FDA Substance ID)

U3P01618RT

FLUOROURACIL

RxCUI 4492

Orange Book

A216494

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": "71288-170_cb5958dc-12bd-4172-b45e-34b591eb316c",
  "productndc": "71288-170",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "216494",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "2.5GM/50ML (50MG/ML)",
        "product_no": "001",
        "approval_date": "Sep 24, 2024"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "FLUOROURACIL",
  "proprietary_name": "Fluorouracil",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA216494",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Fluorouracil",
  "start_marketing_date": "20240924",
  "active_numerator_strength": "50"
}

Related drugs

Other records sharing ATC code L01BC02.

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