TIGLUTIK

TIGLUTIK is an FDA-registered drug product whose active ingredient is RILUZOLE. It is labelled by Italfarmaco SPA taken by oral and marketed as a human prescription drug product. Identifiers on file: NDC 11797-210, application NDA209080, label effective 20260729. It is one of 5 FDA drug label records sharing the active ingredient RILUZOLE. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing RILUZOLE are most often described in connection with: treatment amyotrophic, lateral sclerosis, usage riluzole, tiglutik indicated, tablets usp. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

FDA lists 5 drug label records with RILUZOLE as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

1 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.

What is TIGLUTIK used for?
The FDA label on file for this product does not include a full indications section. Other FDA labels sharing the active ingredient RILUZOLE describe it in connection with: treatment amyotrophic, lateral sclerosis, usage riluzole, tiglutik indicated, tablets usp. Check the specific product label or ask a prescriber before use.

Who makes TIGLUTIK?
Italfarmaco SPA is the labeler of record for TIGLUTIK. 5 FDA label records share the active ingredient RILUZOLE, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does TIGLUTIK come in?
administered by oral. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is TIGLUTIK prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing RILUZOLE?
Yes. 5 FDA drug label records list RILUZOLE as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has TIGLUTIK been recalled?
1 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.