fluorouracil

Generic: fluorouracil

Labeler: encube ethicals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fluorouracil
Generic Name fluorouracil
Labeler encube ethicals, inc.
Dosage Form SOLUTION
Routes
TOPICAL
Active Ingredients

fluorouracil 50 mg/mL

Manufacturer
Encube Ethicals, Inc.

Identifiers & Regulatory

Product NDC 21922-041
Product ID 21922-041_f42c30f3-a83e-4721-8aa1-50d56cb13f4e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215612
Listing Expiration 2026-12-31
Marketing Start 2023-11-06

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 21922041
Hyphenated Format 21922-041

Supplemental Identifiers

RxCUI
310380
UPC
0321922041125
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 ANDA215612 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (21922-041-12) / 10 mL in 1 BOTTLE
source: ndc

Packages (1)

21922-041-12 1 BOTTLE in 1 CARTON (21922-041-12) / 10 mL in 1 BOTTLE

Ingredients (1)

fluorouracil (50 mg/mL)

Linked Drug Pages (1)

Fluorouracil ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "f42c30f3-a83e-4721-8aa1-50d56cb13f4e", "openfda": {"nui": ["N0000000233", "N0000175595"], "upc": ["0321922041125"], "unii": ["U3P01618RT"], "rxcui": ["310380"], "spl_set_id": ["2c631ce7-ea15-4b51-b5bc-4962e3c315cd"], "pharm_class_epc": ["Nucleoside Metabolic Inhibitor [EPC]"], "pharm_class_moa": ["Nucleic Acid Synthesis Inhibitors [MoA]"], "manufacturer_name": ["Encube Ethicals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (21922-041-12)  / 10 mL in 1 BOTTLE", "package_ndc": "21922-041-12", "marketing_start_date": "20231106"}], "brand_name": "Fluorouracil", "product_id": "21922-041_f42c30f3-a83e-4721-8aa1-50d56cb13f4e", "dosage_form": "SOLUTION", "pharm_class": ["Nucleic Acid Synthesis Inhibitors [MoA]", "Nucleoside Metabolic Inhibitor [EPC]"], "product_ndc": "21922-041", "generic_name": "Fluorouracil", "labeler_name": "Encube Ethicals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fluorouracil", "active_ingredients": [{"name": "FLUOROURACIL", "strength": "50 mg/mL"}], "application_number": "ANDA215612", "marketing_category": "ANDA", "marketing_start_date": "20231106", "listing_expiration_date": "20261231"}