Product Information

FLUOROURACIL 5% CREAM is a generic product labeled by Mylan Pharmaceuticals Inc., priced at $0.6034 per GM under NDC 00378479106. Its NADAC has been published 664 times since Dec 5, 2013.

FDA first approved this application before 1982. Its Orange Book therapeutic-equivalence code is AT.

FLUOROURACIL 5% CREAM

Fluorouracil
$0.6034per GM

Strength

5 mg/g

NDC

00378479106

Classification

Generic

Dosage Form

CREAM

Route

TOPICAL

Effective Date

8/19/2026

Active Ingredients

FLUOROURACIL

Approval Type

Authorized Generic (NDA)

FDA Application

NDA016831

FDA Approved

Before 1982

TE Code

AT

On Market Since

9/19/2013

Pharmacological Classes

Nucleic Acid Synthesis Inhibitors
Nucleoside Metabolic Inhibitor

Price Statistics

The NADAC for FLUOROURACIL 5% CREAM has been published 664 times since Dec 5, 2013, and over the history we have for it it has declined 85.2%. The table below summarizes its recorded NADAC range and movement.

Current price$0.6034 per GM
All-time high$4.6025 (Sep 10, 2014)
All-time low$0.5853 (Jul 22, 2026)
52-week high$0.7378
52-week low$0.5853
Median price$1.8576
Average price$2.0793
Largest weekly change+30.8% (Nov 22, 2023)
Weeks tracked664
Tracking sinceDec 5, 2013

Price History

1W

+3.1%

1M

+3.1%

3M

+2.0%

6M

-1.5%

1Y

-18.2%

3Y

-17.2%

5Y

-64.9%

All

-85.2%

Generic Alternatives

No other NADAC-published product shares this drug's active ingredient and strength in a comparable dosage form. Compare the broader picture on the Fluorouracil market page.

Lowest-Cost Alternatives

No alternatives available

No alternatives found with the same active ingredient and strength in a comparable dosage form.

Frequently asked questions

What is the NADAC price of FLUOROURACIL 5% CREAM?

The current National Average Drug Acquisition Cost (NADAC) for FLUOROURACIL 5% CREAM, manufactured by Mylan Pharmaceuticals Inc., is $0.6034 per GM (NDC 00378479106), effective Aug 19, 2026.

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

Over the history we have for it, the NADAC for FLUOROURACIL 5% CREAM has declined 85.2%. It has been tracked across 664 weekly CMS publications since Dec 5, 2013.

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

Since Dec 5, 2013, the NADAC for FLUOROURACIL 5% CREAM has ranged from a low of $0.5853 (Jul 22, 2026) to a high of $4.6025 (Sep 10, 2014), with a median of $1.8576 per GM.

Are there cheaper alternatives to FLUOROURACIL 5% CREAM?

No other NADAC-published product currently shares the active ingredient and strength of FLUOROURACIL 5% CREAM in a comparable dosage form, so no direct lower-cost alternative is listed.

Who manufactures FLUOROURACIL 5% CREAM?

FLUOROURACIL 5% CREAM (NDC 00378479106) is labeled by Mylan Pharmaceuticals Inc., and CMS classifies it as a generic product.