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United States · US · US:51672-4118_170232f3-4992-1e1a-e063-6394a90a38e9

Fluorouracil

Orange BookUNIISPLATC L01BC02

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

Identification

ManufacturerTaro Pharmaceuticals U.S.A., Inc.
CountryUS (United States)
ATC codeL01BC02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    5167241182
    1 TUBE in 1 CARTON (51672-4118-2) / 25 g in 1 TUBE
  • ndc11
    5167241185
    5 g in 1 TUBE (51672-4118-5)
  • ndc11
    5167241186
    1 TUBE in 1 CARTON (51672-4118-6) / 40 g in 1 TUBE

Annotations

UNII (FDA Substance ID)
U3P01618RT
FLUOROURACIL
RxCUI 4492
Orange Book
A090368
AB
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": "TOPICAL",
  "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": "51672-4118_170232f3-4992-1e1a-e063-6394a90a38e9",
  "productndc": "51672-4118",
  "dosage_form": "CREAM",
  "orange_book": {
    "appl_no": "090368",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5%",
        "product_no": "001",
        "approval_date": "Mar 5, 2010"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "FLUOROURACIL",
  "proprietary_name": "Fluorouracil",
  "active_ingred_unit": "mg/g",
  "application_number": "ANDA090368",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Fluorouracil",
  "start_marketing_date": "20100305",
  "active_numerator_strength": "50"
}

Related drugs

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