Quick answers
- What is Riluzole used for?
- The FDA-approved label (Tiglutik, Edw Pharma, Inc, July 27, 2026) says: “TIGLUTIK is indicated for the treatment of amyotrophic lateral sclerosis (ALS). TIGLUTIK is indicated for the treatment of amyotrophic lateral sclerosis (ALS)” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Riluzole have a boxed warning?
- No. None of the 6 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Riluzole?
- The FDA drug shortage list shows “Current shortage” for a product of this medicine (updated October 15, 2026). Ask your pharmacist about alternatives.
- Has Riluzole been recalled?
- FDA enforcement reports list 1 recall of products of this medicine; the newest started October 20, 2023 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Riluzole?
- 7 companies list prescription products of Riluzole in the FDA NDC Directory, including Ascend Laboratories, LLC, Florida Pharmaceutical Products, LLC and AvKARE.
What Riluzole is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
TIGLUTIK is indicated for the treatment of amyotrophic lateral sclerosis (ALS). TIGLUTIK is indicated for the treatment of amyotrophic lateral sclerosis (ALS)
— FDA label: Tiglutik, Edw Pharma, Inc, effective July 27, 2026. Read the full label on DailyMed →
The FDA has 6 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
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.
The label quoted above has no boxed warning.
0 of 6 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet, film coated · Tablet · Liquid · Suspension |
|---|---|
| Route | Oral |
| Prescription products | 7 in the FDA NDC Directory |
| Brand names | Tiglutik |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| riluzole 50 mg tablet | Generic | $0.2913 per tablet |
| riluzole 50 mg tablet, film coated | Generic | $0.2913 per tablet |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
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.
- Ascend Laboratories, LLC1 product
- Florida Pharmaceutical Products, LLC1 product
- AvKARE1 product
- Glenmark Pharmaceuticals Inc., USA1 product
- Edw Pharma, Inc1 product
- Sun Pharmaceutical Industries, Inc.1 product
- Italfarmaco SpA1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA209080 TIGLUTIK KIT | Italfarmaco SA | September 5, 2018 | 3, latest September 11, 2025 2025: Labeling · 2020: Labeling · 2019: Efficacy |
Generic approvals (4)
- ANDA091394Glenmark Pharms Ltd · June 18, 2013
- ANDA091417Sun Pharm Inds Ltd · June 18, 2013
- ANDA204048Alkem Labs Ltd · March 30, 2016
- ANDA206045Kenton · December 9, 2019
Shortage status
Current shortage · updated October 15, 2026 · first posted January 26, 2024
| Product | Tiglutik, Oral Suspension, 50 mg/10 mL (NDC 70726-0303-1) |
|---|---|
| Availability | Unavailable |
| Reason given | Requirements related to complying with good manufacturing practices |
| Company | EDW Pharma, Inc. (formerly Italfarmaco Pharma, Inc.) |
Ask your pharmacist whether your product is affected and what the options are.
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.
-
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
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) | 199206, 2058147, 2059266 |
|---|---|
| SPL set ID of the quoted label | 75d68f19-4208-109e-e053-2991aa0ac857 |
| FDA labels (SPL) | 6 |
| FDA applications | NDA209080, 4 ANDA |
| Active ingredients (FDA) | RILUZOLE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Tiglutik, Edw Pharma, Inc, effective July 27, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- 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 recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- 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 →