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Prescription medicine · generic available

Methoxsalen

Drug class: Photoactivated Radical Generator, Psoralen

The FDA’s “Established Pharmacologic Class”: the group of medicines that work in a similar way.

Full FDA label All drugs

Official FDA data, not advice

Everything here comes from the U.S. Food and Drug Administration (FDA): the drug label, the NDC Directory, Drugs@FDA, recall reports and the drug shortage list. Each fact shows its source and date.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

In an emergency, call 911. If someone may have taken too much of a medicine, call Poison Help: 1‑800‑222‑1222.

At a glance

YesBoxed warning
None listedFDA shortage list
1Recalls (FDA reports)
1Companies
2014First FDA approval on file

Quick answers

What is Methoxsalen used for?
The FDA-approved label (Methoxsalen, Strides Pharma Science Limited, June 24, 2026) says: “III. INDICATIONS AND USAGE Photochemotherapy (Methoxsalen with long wave UVA radiation) is indicated for the symptomatic control of severe, recalcitrant, disabling psoriasis not adequately responsive to other forms of therapy and when the diagnosis has been supported by biopsy. Methoxsalen is intended to be administered only in conjunction with a schedule of controlled doses of long wave ultraviolet radiation.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Does Methoxsalen have a boxed warning?
Yes. The FDA label for Methoxsalen has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
Is there a shortage of Methoxsalen?
No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
Has Methoxsalen been recalled?
FDA enforcement reports list 1 recall of products of this medicine; the newest started December 29, 2023 (Class II). A recall usually concerns specific lots, not every product.
Who makes Methoxsalen?
1 company lists prescription products of Methoxsalen in the FDA NDC Directory, including Strides Pharma Science Limited.

What Methoxsalen is used for

Quoted from the “Indications and Usage” section of the FDA-approved label.

III. INDICATIONS AND USAGE Photochemotherapy (Methoxsalen with long wave UVA radiation) is indicated for the symptomatic control of severe, recalcitrant, disabling psoriasis not adequately responsive to other forms of therapy and when the diagnosis has been supported by biopsy. Methoxsalen is intended to be administered only in conjunction with a schedule of controlled doses of long wave ultraviolet radiation.

— FDA label: Methoxsalen, Strides Pharma Science Limited, effective June 24, 2026. Read the full label on DailyMed →

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

Boxed warning

A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.

This label has a boxed warning. Read it on the full label →

Forms and how it is given

Dosage formsCapsule, liquid filled
RouteOral
Prescription products1 in the FDA NDC Directory

Companies that list this medicine

Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.

FDA approval history

  • ANDA: Abbreviated New Drug Application: how a generic version is approved.

Generic approvals (1)

Shortage status

The FDA drug shortage list does not show these products.

FDA Drug Shortages database →

Recalls

From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.

  1. December 29, 2023 · Class II · Terminated · D-0260-2024

    Failed Dissolution Specifications

    Methoxsalen Capsules, USP 10mg, 50-count bottle, Rx Only, Manufactured by: Strides Pharma Science Ltd. Bengaluru - 562106, India. Distributed by:Strides Pharma Inc. East Brunswick, NJ 08816, NDC 64380-752-16 — Strides Pharma Inc.

What do the recall classes mean?

Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).

Official identifiers

RxCUI (RxNorm)1812434
SPL set ID of the quoted labela6ec8292-9189-4ebd-862a-e1725eb29eef
FDA labels (SPL)1
FDA applications1 ANDA
Active ingredients (FDA)METHOXSALEN

Sources

  1. FDA-approved label on DailyMed (National Library of Medicine) — Methoxsalen, Strides Pharma Science Limited, effective June 24, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
  2. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  3. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  4. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
  5. Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026

openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →

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