Product Information

FLUOROURACIL 5% TOPICAL SOLN is a generic product labeled by Encube Ethicals, Inc., priced at $4.2070 per ML under NDC 21922004112. Its NADAC has been published 124 times since Apr 10, 2024.

FDA first approved this application on Nov 2, 2023. Its Orange Book therapeutic-equivalence code is AT.

FLUOROURACIL 5% TOPICAL SOLN

Fluorouracil
$4.2070per ML

Strength

50 mg/mL

NDC

21922004112

Classification

Generic

Dosage Form

SOLUTION

Route

TOPICAL

Effective Date

8/19/2026

Active Ingredients

FLUOROURACIL

Approval Type

Generic (ANDA)

FDA Application

ANDA215612

FDA Approved

11/2/2023

TE Code

AT

On Market Since

11/6/2023

Pharmacological Classes

Nucleic Acid Synthesis Inhibitors
Nucleoside Metabolic Inhibitor

Price Statistics

The NADAC for FLUOROURACIL 5% TOPICAL SOLN has been published 124 times since Apr 10, 2024, and over the history we have for it it has declined 13.1%. The table below summarizes its recorded NADAC range and movement.

Current price$4.2070 per ML
All-time high$5.5164 (Jul 10, 2024)
All-time low$3.7959 (Nov 20, 2024)
52-week high$4.7282
52-week low$4.0784
Median price$4.4507
Average price$4.5015
Largest weekly change+17.8% (Jun 19, 2024)
Weeks tracked124
Tracking sinceApr 10, 2024

Price History

1W

+3.2%

1M

+3.2%

3M

-3.2%

6M

-9.9%

1Y

-10.3%

3Y

N/A

5Y

N/A

All

-13.1%

Generic Alternatives

The matcher finds 1 manufacturer offering a NADAC-published product with this drug's active ingredient and strength in a comparable dosage form (cheapest from each manufacturer, up to 10 shown below). None of the shown alternatives sit below the current price. These are candidates to verify clinically, not guaranteed substitutes — see our generic drug prices guide.

Frequently asked questions

What is the NADAC price of FLUOROURACIL 5% TOPICAL SOLN?

The current National Average Drug Acquisition Cost (NADAC) for FLUOROURACIL 5% TOPICAL SOLN, manufactured by Encube Ethicals, Inc., is $4.2070 per ML (NDC 21922004112), effective Aug 19, 2026.

How has the price of FLUOROURACIL 5% TOPICAL SOLN changed over time?

Over the history we have for it, the NADAC for FLUOROURACIL 5% TOPICAL SOLN has declined 13.1%. It has been tracked across 124 weekly CMS publications since Apr 10, 2024.

What are the highest and lowest recorded NADAC prices for FLUOROURACIL 5% TOPICAL SOLN?

Since Apr 10, 2024, the NADAC for FLUOROURACIL 5% TOPICAL SOLN has ranged from a low of $3.7959 (Nov 20, 2024) to a high of $5.5164 (Jul 10, 2024), with a median of $4.4507 per ML.

Are there cheaper alternatives to FLUOROURACIL 5% TOPICAL SOLN?

1 manufacturer publishes a NADAC-priced product with the same active ingredient and strength as FLUOROURACIL 5% TOPICAL SOLN in a comparable dosage form, but none are currently priced below it.

Who manufactures FLUOROURACIL 5% TOPICAL SOLN?

FLUOROURACIL 5% TOPICAL SOLN (NDC 21922004112) is labeled by Encube Ethicals, Inc., and CMS classifies it as a generic product.