Riluzole is a prescription medicine (Benzothiazole). The sections below reproduce one FDA label for it, named under "Label". Products in other forms, strengths or from other makers have their own labels, which can differ.
On the FDA shortage list — 1 product is unavailable or in limited supply. Which forms
- Type
- Prescription only (Rx)
- Brand names
- Teglutik, Tiglutik
- Drug class
- Benzothiazole
- Taken
- Oral
- Label
- Italfarmaco SPA, revised July 29, 2026 · full label on DailyMed
- Generic
- FDA-approved (4 companies) · details
Is there a generic Riluzole?
Yes. The FDA has approved generic Riluzole from 4 companies whose approvals are active. The earliest of these was approved in 2003.
An FDA approval does not always mean the generic is already in pharmacies: patent disputes and settlements can delay a launch for years. Your pharmacist can tell you whether a generic is actually available and covered by your plan.
The FDA rates these generics as therapeutically equivalent to the brand ("A" rating): same active ingredient, strength, dosage form and effect. Pharmacists can usually substitute them unless the prescriber says otherwise.
Companies with an approved generic
Alkem Labs Ltd, Glenmark Pharms Ltd, Impax Labs, Kenton
Brand-name versions
- Rilutek Azurity, approved 1995 Discontinued
- Tiglutik Kit Italfarmaco Sa, approved 2018
- Exservan Aquestive, approved 2019 Discontinued
Source: Drugs@FDA (via openFDA), checked October 29, 2026. Marketing status is what companies report to the FDA; whether a pharmacy stocks a product, and what your insurance covers, can differ.
Dosage:
we do not reproduce dosing instructions. The right dose depends on the person and the condition and is set by the prescriber or pharmacist. Dosage section of the full label.
Riluzole in the news
We have not covered this medicine yet. Latest news
Shortage status
| Product | Availability | Expected supply / notes |
|---|---|---|
| Tiglutik, Oral Suspension, 50 mg/10 mL (NDC 70726-0303-1) EDW Pharma, Inc. (formerly Italfarmaco Pharma, Inc.) |
Unavailable | Estimated recovery: TBD In shortage · October 15, 2026 |
| Teglutik, Oral Suspension, 5 mg/1 mL (NDC 70726-0305-1) EDW Pharma, Inc. (formerly Italfarmaco Pharma, Inc.) |
Available | — In shortage · October 15, 2026 |
| Teglutik, Oral Suspension, 5 mg/1 mL (NDC 70726-0306-1) EDW Pharma, Inc. (formerly Italfarmaco Pharma, Inc.) |
Available | — In shortage · October 15, 2026 |
| Teglutik, Oral Suspension, 5 mg/1 mL (NDC 70726-0304-1) EDW Pharma, Inc. (formerly Italfarmaco Pharma, Inc.) |
Available | — In shortage · October 15, 2026 |
Recalls
-
Class II Terminated
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)
Reason: Failed Viscosity Specifications: Out-of-specification test results for viscosity
Lots, distribution and details
- Lots / codes
- LOT# 2231901, Exp. 11/30/2025; 2307901, Exp. 03/31/2026
- Distribution
- Distributed to one distributor in TN who may have further distributed.
- Quantity
- 1,792 bottles
- Recall started
- October 20, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0115-2024
Have this medicine at home? Compare the lot number and expiry date on your package with the recall. Do not stop taking a prescribed medicine on your own — stopping suddenly can be riskier than the recalled lot. Your pharmacist can check it and usually swap it for an unaffected one.
Get alerts for Riluzole
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Source: FDA structured product labeling, retrieved through openFDA. Label text is shown as published by the FDA, without editing; long sections are shortened, marked […]. openFDA data are not validated for clinical use — always check the current label and ask a doctor or pharmacist about your own treatment. Set ID 20b7165a-eb4d-42a0-b2d8-16eff90a214e.