Fluorouracil

Orange BookUNIISPLATC L01BC02

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

Identification

ManufacturerGland Pharma Limited

CountryUS (United States)

ATC codeL01BC02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6808326910
10 VIAL in 1 CARTON (68083-269-10) / 10 mL in 1 VIAL (68083-269-01)

Annotations

UNII (FDA Substance ID)

U3P01618RT

FLUOROURACIL

RxCUI 4492

Orange Book

A210123

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": "68083-269_0e5faa31-6fd8-49b5-b838-1278cf068666",
  "productndc": "68083-269",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "210123",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "500MG/10ML (50MG/ML)",
        "product_no": "001",
        "approval_date": "Oct 27, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "1GM/20ML (50MG/ML)",
        "product_no": "002",
        "approval_date": "Oct 27, 2017"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "FLUOROURACIL",
  "proprietary_name": "Fluorouracil",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA210123",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Fluorouracil",
  "start_marketing_date": "20171107",
  "active_numerator_strength": "50"
}

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