Active ingredient
Deutetrabenazine
11 finished FDA listings contain Deutetrabenazine as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- DEUTETRABENAZINE
- Dosage forms
- Tablet, Coated, Tablet, Film Coated, Extended Release
- Routes
- Oral
- Manufacturers / labelers
- 1
- Strengths listed
- 12 mg/1 · 18 mg/1 · 24 mg/1 · 30 mg/1 · 36 mg/1 · 42 mg/1 · 48 mg/1 · 6 mg/1 · 9 mg/1
- Brand names in FDA listings
- Austedo, Austedo Xr
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 1876905
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 208082 | TEVA BRANDED PHARM | 2017-04-03 | 3 |
| NDA 216354 | TEVA | 2023-02-17 | 8 |
Official labeling on DailyMed
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.