Rx only · Cream · Topical
Fluorouracil
Brands: Efudex · Tolak · Fluorouracil
9 ACTIVE SUPPLIERS — US
openFDA · updated weekly
US9 NDCs
9 active makers
9 active makers
UKComing
soon
soon
CAComing
soon
soon
AUComing
soon
soon
EUComing
soon
soon
US acquisition costNADAC · per unit
Average across 7 priced NDCs. A benchmark of pharmacy acquisition cost — not a retail quote.
$0.586
Latest avg · Jul 22, 2026
-5%
Since Dec 17, 2025
9
Active US suppliers
36%
Top-2 supplier share*
Medicaid dispensing volumeSDUD · per quarter
Prescriptions dispensed under Medicaid (fee-for-service + managed care), summed nationally. The closest free proxy to sales volume — Medicaid only, not all-payer.
15K
Rx · 2026 Q1
594K
Units dispensed
+3%
Rx vs. year ago
5
Quarters · since 2025 Q1
Who makes it9 active · 0 exited
US labelers as registered with FDA. Repackagers relabel another company's product; share* is of listed packages, not sales.
| Labeler | Type | Packages | Status |
|---|---|---|---|
| SUN PHARMACEUTICAL INDUSTRIES, INC. | unknown | 3 | SUPPLYING |
| Mylan Pharmaceuticals Inc. | unknown | 1 | SUPPLYING |
| Accord Healthcare Inc. | unknown | 1 | SUPPLYING |
| Dr.Reddy's laboratories Limited | unknown | 1 | SUPPLYING |
| Encube Ethicals, Inc. | unknown | 1 | SUPPLYING |
| Bausch Health US, LLC | unknown | 1 | SUPPLYING |
| Mayne Pharma Inc. | unknown | 1 | SUPPLYING |
| NorthStar Rx LLC | unknown | 1 | SUPPLYING |
| HILL DERMACEUTICALS, INC. | unknown | 1 | SUPPLYING |
Regulatory & supply eventsFDA · US
Shortages, recalls, and registration changes attached to this drug concept.
- Nov 21, 2012RECALLRecall (Class II): Fluorouracil Topical Cream USP, 5%, 40 g Tube, Rx only, Mfd. by: Taro Pharmaceutical Industries, Ltd. Haifa Bay, Israel…
Product Lacks Stability: Out-of-specification (OOS) results were observed for assay and description in retain samples. — Recalling firm: Taro Pharmaceuticals U.S.A., Inc. — Nationwide and Puerto Rico
Pill