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United States · US · US:75907-169_39a2cbc0-f588-5397-e063-6394a90a5390

FLUOROURACIL

Orange BookUNIISPLATC L01BC02

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

Identification

ManufacturerDr. Reddy's Laboratories Inc.
CountryUS (United States)
ATC codeL01BC02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7590716911
    1 TUBE in 1 CARTON (75907-169-11) / 30 g in 1 TUBE

Annotations

UNII (FDA Substance ID)
U3P01618RT
FLUOROURACIL
RxCUI 4492
Orange Book
N020985
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": "75907-169_39a2cbc0-f588-5397-e063-6394a90a5390",
  "productndc": "75907-169",
  "dosage_form": "CREAM",
  "orange_book": {
    "appl_no": "020985",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "0.5%",
        "product_no": "001",
        "approval_date": "Oct 27, 2000"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "FLUOROURACIL",
  "proprietary_name": "FLUOROURACIL",
  "active_ingred_unit": "mg/g",
  "application_number": "NDA020985",
  "marketing_category": "NDA AUTHORIZED GENERIC",
  "nonproprietary_name": "Fluorouracil Cream, 0.5%",
  "start_marketing_date": "20250706",
  "active_numerator_strength": "5"
}

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