Pillstats
Rx only · Gel · Ophthalmic

Loteprednol Etabonate

Brands: Lotemax · Lotemax Sm · Loteprednol Etabonate

4 ACTIVE SUPPLIERS — US
openFDA · updated weekly
US6 NDCs
4 active makers
UKComing
soon
CAComing
soon
AUComing
soon
EUComing
soon
ATC—
RxCUI (US)52177
US makers4 labelers
Packages9
DEA / ScheduleNone

US acquisition costNADAC · per unit

Average across 5 priced NDCs. A benchmark of pharmacy acquisition cost — not a retail quote.

$8.42$16.85$25.27$33.69Dec 2025Apr 2026Jul 2026
$28.547
Latest avg · Jul 22, 2026
-3%
Since Dec 17, 2025
4
Active US suppliers
78%
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.

7381.5K2.2K3.0K2025 Q12025 Q22025 Q32025 Q42026 Q1
2.3K
Rx · 2026 Q1
12K
Units dispensed
+25%
Rx vs. year ago
5
Quarters · since 2025 Q1

Who makes it4 active · 0 exited

US labelers as registered with FDA. Repackagers relabel another company's product; share* is of listed packages, not sales.

LabelerTypePackagesStatus
Bausch & Lomb Incorporatedunknown6SUPPLYING
Armas Pharmaceuticals Inc.unknown1SUPPLYING
Sentiss Pharmaceuticals LLCunknown1SUPPLYING
Bausch & Lomb Americas Inc.unknown1SUPPLYING

Regulatory & supply eventsFDA · US

Shortages, recalls, and registration changes attached to this drug concept.

  • Jun 17, 2019
    RECALLRecall (Class III): Lotemax (loteprednol etabonate ophthalmic gel 0.5%), Sterile, Rx Only, 5 g box, Bausch & Lomb, a division of Valeant Ph…

    Failed Stability Specifications: Out of specification for viscosity. — Recalling firm: Bausch & Lomb — Nationwide in the U.S.