tolak

Generic: fluorouracil

Labeler: hill dermaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name tolak
Generic Name fluorouracil
Labeler hill dermaceuticals, inc.
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

fluorouracil .04 g/g

Manufacturer
HILL DERMACEUTICALS, INC.

Identifiers & Regulatory

Product NDC 28105-421
Product ID 28105-421_db3a1489-fcb1-4442-b309-4eb8ad9b9f46
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA022259
Listing Expiration 2026-12-31
Marketing Start 2015-09-18

Pharmacologic Class

Established (EPC)
nucleoside metabolic inhibitor [epc]
Mechanism of Action
nucleic acid synthesis inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 28105421
Hyphenated Format 28105-421

Supplemental Identifiers

RxCUI
1669868 1669873
UNII
U3P01618RT
NUI
N0000000233 N0000175595

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name tolak (source: ndc)
Generic Name fluorouracil (source: ndc)
Application Number NDA022259 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • .04 g/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (28105-421-40) / 40 g in 1 TUBE
source: ndc

Packages (1)

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

Ingredients (1)

fluorouracil (.04 g/g)

Linked Drug Pages (1)

TOLAK ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "db3a1489-fcb1-4442-b309-4eb8ad9b9f46", "openfda": {"nui": ["N0000000233", "N0000175595"], "unii": ["U3P01618RT"], "rxcui": ["1669868", "1669873"], "spl_set_id": ["59de2709-00b8-4f0a-867c-f0dfeb947192"], "pharm_class_epc": ["Nucleoside Metabolic Inhibitor [EPC]"], "pharm_class_moa": ["Nucleic Acid Synthesis Inhibitors [MoA]"], "manufacturer_name": ["HILL DERMACEUTICALS, INC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (28105-421-40)  / 40 g in 1 TUBE", "package_ndc": "28105-421-40", "marketing_start_date": "20150918"}], "brand_name": "TOLAK", "product_id": "28105-421_db3a1489-fcb1-4442-b309-4eb8ad9b9f46", "dosage_form": "CREAM", "pharm_class": ["Nucleic Acid Synthesis Inhibitors [MoA]", "Nucleoside Metabolic Inhibitor [EPC]"], "product_ndc": "28105-421", "generic_name": "FLUOROURACIL", "labeler_name": "HILL DERMACEUTICALS, INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "TOLAK", "active_ingredients": [{"name": "FLUOROURACIL", "strength": ".04 g/g"}], "application_number": "NDA022259", "marketing_category": "NDA", "marketing_start_date": "20150918", "listing_expiration_date": "20261231"}