Levamisole: Current U.S. Human Product Status

Levamisole requires unusually careful product-status language. It has historical human use, but that history should not be converted into a claim that human levamisole tablets are currently sold at U.S. retail pharmacies.

What the current FDA Orange Book shows

The FDA's 2026 Orange Book lists levamisole hydrochloride tablets under the Discontinued Drug Product List. The listed product is Ergamisol, equivalent to 50 mg levamisole base, under NDA 020035. The Orange Book footnote indicates an FDA determination that the product was not discontinued or withdrawn for safety or effectiveness reasons; that determination does not make the product a currently marketed U.S. retail drug.

Do not confuse ingredient records with a marketed prescription product

Levamisole or levamisole hydrochloride can appear in substance databases, bulk-ingredient records or other regulatory contexts. Those records do not by themselves establish that an FDA-approved human levamisole tablet is currently marketed and available from a community pharmacy.

Current access questions

This page does not claim that Access Care Pharmacy stocks, sells or can routinely obtain human levamisole. A person who encounters an old product page, old price or historical brand reference should first verify the current U.S. product status with a pharmacist and prescriber.

No cancer-treatment or unverified human-use marketing

This page does not promote levamisole as a cancer treatment, does not provide human dosing instructions, and does not carry forward historical or unverified indications as current U.S. approved uses. Product and regulatory status must be separated from research or historical discussion.

For a current regulatory or product-availability question, use the pharmacy consultation page. Any human treatment decision belongs with the appropriate prescriber.