Quick answers
- What is Tiglutik?
- Tiglutik is a brand name of Riluzole, a prescription medicine. The FDA NDC Directory lists 2 Tiglutik products in 2 strengths and forms.
- Who makes Tiglutik?
- Italfarmaco Sa holds the FDA application for Tiglutik (NDA209080, approved September 5, 2018). 1 other company (repackagers or distributors) also list Tiglutik products.
- Is there a generic or store brand of Tiglutik?
- Other products of Riluzole are listed with the FDA, but none in exactly the same strength and form as a Tiglutik product.
- Has Tiglutik been recalled?
- FDA enforcement reports list 1 recall of Tiglutik products; the newest started October 20, 2023. A recall usually concerns specific lots, not every product.
What Tiglutik is
Each Tiglutik product as listed in the FDA NDC Directory, by active ingredient, strength and form, with its official label. “Same medicine, other names” counts the other products with exactly the same active ingredients, strength and form (generic versions, store brands and other brands); inactive ingredients can differ.
Riluzole · prescription medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| riluzole 50 mg/10 mL liquid (oral) | Tiglutik | None listed | DailyMed |
| riluzole 50 mg/10 mL suspension (oral) | Tiglutik | None listed | DailyMed |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Riluzole →
FDA approval
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Holder | First approved | Products |
|---|---|---|---|
| NDA209080 | Italfarmaco Sa | September 5, 2018 | 2 |
Companies that list Tiglutik
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Tiglutik products.
- Edw Pharma, Inc1 product
- Italfarmaco SPA1 product
Recalls
From FDA enforcement reports, matched by the product’s NDC code or label. A recall usually covers specific lots: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
October 20, 2023 · Class II · Terminated · D-0115-2024
Failed Viscosity Specifications: Out-of-specification test results for viscosity
Tiglutik (riluzole) Oral Suspension 50 mg/10 mL (5 mg/mL), 600 mL (two bottles/300 mL each), RX only, Manufactured for ITF Pharma, Inc., Berwyn, PA 19312 USA NDC:70726-0303-1 (carton) and 70726-0303-2 (bottle) — ITF PHARMA INC
Sources
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug labeling (SPL, openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- NADAC (National Average Drug Acquisition Cost) 2026 — Centers for Medicare & Medicaid Services (CMS), data.medicaid.gov, list of November 4, 2026, retrieved November 7, 2026
Which names get a brand page: a name the NDC Directory lists for a medicine, held by one company (the FDA application holder, or the company named on most of its products), that is not just a description, and that is not the only product of its medicine.