Active ingredient
Tasimelteon
5 finished FDA listings contain Tasimelteon as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- TASIMELTEON
- Dosage forms
- Capsule, Capsule, Gelatin Coated, Suspension
- Routes
- Oral
- Manufacturers / labelers
- 4
- Strengths listed
- 20 mg/1 · 4 mg/ml
- Brand names in FDA listings
- Hetlioz, Hetlioz Lq
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 1490468
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 |
|---|---|---|---|
| NDA 205677 | VANDA PHARMS INC | 2014-01-31 | 1 |
| NDA 214517 | VANDA PHARMS INC | 2020-12-01 | 1 |
| ANDA 211601 | TEVA PHARMS USA INC | 2022-12-12 | 1 |
| ANDA 211607 | APOTEX | 2022-12-20 | 1 |
| ANDA 211654 | MSN | 2023-01-12 | 1 |
Official labeling on DailyMed
- TASIMELTEON CAPSULE, GELATIN COATED [TEVA PHARMACEUTICALS, INC.] · version 6 · 2026-09-03
- HETLIOZ (TASIMELTEON) CAPSULE HETLIOZ LQ (TASIMELTEON) SUSPENSION [VANDA PHARMACEUTICALS INC.] · version 15 · 2026-08-06
- TASIMELTEON CAPSULE [AMNEAL PHARMACEUTICALS NY LLC] · version 7 · 2023-03-31
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.