TOLAK

Orange BookUNIIATC L01BC02

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

Identification

ManufacturerHILL DERMACEUTICALS, INC.

CountryUS (United States)

ATC codeL01BC02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
2810542140
1 TUBE in 1 CARTON (28105-421-40) / 40 g in 1 TUBE

Annotations

UNII (FDA Substance ID)

U3P01618RT

FLUOROURACIL

RxCUI 4492

Orange Book

N022259

Raw payload (JSON)

{
  "unii": {
    "unii": "U3P01618RT",
    "rxcui": "4492",
    "inchikey": "GHASVSINZRGABV-UHFFFAOYSA-N",
    "display_name": "FLUOROURACIL",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "TOPICAL",
  "productid": "28105-421_db3a1489-fcb1-4442-b309-4eb8ad9b9f46",
  "productndc": "28105-421",
  "dosage_form": "CREAM",
  "orange_book": {
    "appl_no": "022259",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "4%",
        "product_no": "001",
        "approval_date": "Sep 18, 2015"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "FLUOROURACIL",
  "proprietary_name": "TOLAK",
  "active_ingred_unit": "g/g",
  "application_number": "NDA022259",
  "marketing_category": "NDA",
  "nonproprietary_name": "FLUOROURACIL",
  "start_marketing_date": "20150918",
  "active_numerator_strength": ".04"
}

Related drugs

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