Active ingredient
Riluzole
10 finished FDA listings contain Riluzole as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- RILUZOLE
- Dosage forms
- Liquid, Suspension, Tablet, Tablet, Film Coated
- Routes
- Oral
- Manufacturers / labelers
- 8
- Strengths listed
- 5 mg/ml · 50 mg/1 · 50 mg/10ml
- Brand names in FDA listings
- Teglutik, Tiglutik
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 35623
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| ANDA 091394 | GLENMARK PHARMS LTD | 2013-06-18 | 1 |
| ANDA 091417 | SUN PHARM INDS LTD | 2013-06-18 | 1 |
| ANDA 204048 | ALKEM LABS LTD | 2016-03-30 | 1 |
| NDA 209080 | ITALFARMACO SA | 2018-09-05 | 2 |
| ANDA 206045 | KENTON | 2019-12-09 | 2 |
Official labeling on DailyMed
- TIGLUTIK (RILUZOLE) SUSPENSION [ITALFARMACO SPA] · version 1 · 2026-08-03
- TIGLUTIK (RILUZOLE) LIQUID [EDW PHARMA, INC] · version 22 · 2026-07-28
- RILUZOLE TABLET [ASCEND LABORATORIES, LLC] · version 13 · 2026-07-16
- RILUZOLE TABLET, FILM COATED [FLORIDA PHARMACEUTICAL PRODUCTS, LLC] · version 8 · 2026-04-27
- RILUZOLE TABLET, FILM COATED [AVKARE] · version 5 · 2026-03-05
- TEGLUTIK (RILUZOLE) LIQUID [EDW PHARMA, INC] · version 7 · 2026-01-02
- TEGLUTIK (RILUZOLE) LIQUID [EDW PHARMA] · version 2 · 2026-01-02
- TEGLUTIK (RILUZOLE) LIQUID [EDW PHARMA] · version 3 · 2026-01-02
- RILUZOLE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA] · version 12 · 2024-01-04
- RILUZOLE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.] · version 10 · 2020-08-20
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.