fluorouracil

Generic: fluorouracil

Labeler: mylan pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name fluorouracil
Generic Name fluorouracil
Labeler mylan pharmaceuticals inc.
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

fluorouracil 5 mg/g

Manufacturer
Mylan Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 0378-4791
Product ID 0378-4791_1ff72539-1af5-41bf-8720-1ba12df35abc
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA016831
Listing Expiration 2026-12-31
Marketing Start 2013-09-19

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 03784791
Hyphenated Format 0378-4791

Supplemental Identifiers

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 fluorouracil (source: ndc)
Generic Name fluorouracil (source: ndc)
Application Number NDA016831 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (0378-4791-06) / 40 g in 1 TUBE
source: ndc

Packages (1)

0378-4791-06 1 TUBE in 1 CARTON (0378-4791-06) / 40 g in 1 TUBE

Ingredients (1)

fluorouracil (5 mg/g)

Linked Drug Pages (1)

Fluorouracil ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "1ff72539-1af5-41bf-8720-1ba12df35abc", "openfda": {"nui": ["N0000000233", "N0000175595"], "unii": ["U3P01618RT"], "spl_set_id": ["744737c5-0d96-4214-82ab-6cff016b1ea0"], "pharm_class_epc": ["Nucleoside Metabolic Inhibitor [EPC]"], "pharm_class_moa": ["Nucleic Acid Synthesis Inhibitors [MoA]"], "manufacturer_name": ["Mylan Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (0378-4791-06)  / 40 g in 1 TUBE", "package_ndc": "0378-4791-06", "marketing_start_date": "20130919"}], "brand_name": "Fluorouracil", "product_id": "0378-4791_1ff72539-1af5-41bf-8720-1ba12df35abc", "dosage_form": "CREAM", "pharm_class": ["Nucleic Acid Synthesis Inhibitors [MoA]", "Nucleoside Metabolic Inhibitor [EPC]"], "product_ndc": "0378-4791", "generic_name": "Fluorouracil", "labeler_name": "Mylan Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fluorouracil", "active_ingredients": [{"name": "FLUOROURACIL", "strength": "5 mg/g"}], "application_number": "NDA016831", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20130919", "listing_expiration_date": "20261231"}