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 CREAM
Routes
TOPICAL
Active Ingredients

fluorouracil 2 g/40g

Manufacturer
Encube Ethicals, Inc.

Identifiers & Regulatory

Product NDC 21922-049
Product ID 21922-049_f33d88a4-f57f-45c7-8c13-94d69e4d7931
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216942
Listing Expiration 2026-12-31
Marketing Start 2025-02-14

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 21922049
Hyphenated Format 21922-049

Supplemental Identifiers

RxCUI
105583
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 ANDA216942 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 2 g/40g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (21922-049-17) / 40 g in 1 TUBE
source: ndc

Packages (1)

21922-049-17 1 TUBE in 1 CARTON (21922-049-17) / 40 g in 1 TUBE

Ingredients (1)

fluorouracil (2 g/40g)

Linked Drug Pages (1)

FLUOROURACIL ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "f33d88a4-f57f-45c7-8c13-94d69e4d7931", "openfda": {"nui": ["N0000000233", "N0000175595"], "unii": ["U3P01618RT"], "rxcui": ["105583"], "spl_set_id": ["30294dd2-40fb-420d-b838-376343308895"], "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 TUBE in 1 CARTON (21922-049-17)  / 40 g in 1 TUBE", "package_ndc": "21922-049-17", "marketing_start_date": "20250214"}], "brand_name": "FLUOROURACIL", "product_id": "21922-049_f33d88a4-f57f-45c7-8c13-94d69e4d7931", "dosage_form": "CREAM", "pharm_class": ["Nucleic Acid Synthesis Inhibitors [MoA]", "Nucleoside Metabolic Inhibitor [EPC]"], "product_ndc": "21922-049", "generic_name": "Fluorouracil", "labeler_name": "Encube Ethicals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "FLUOROURACIL", "active_ingredients": [{"name": "FLUOROURACIL", "strength": "2 g/40g"}], "application_number": "ANDA216942", "marketing_category": "ANDA", "marketing_start_date": "20250214", "listing_expiration_date": "20261231"}