deutetrabenazine
deutetrabenazine is listed in the FDA National Drug Code directory with 10 NDC codes, marketed under brand names including AUSTEDO, AUSTEDO XR. Available dosage forms: kit, tablet, film coated, extended release.
Drug Details
- Generic Name
- deutetrabenazine
- Brand Names
- AUSTEDO, AUSTEDO XR
- Application Number
- NDA208082
- Sponsor
- Teva Neuroscience, Inc.
- NDC Codes
- 10
- Dosage Forms
- KIT, TABLET, FILM COATED, EXTENDED RELEASE
- Routes
- ORAL
- Active Ingredients
- DEUTETRABENAZINE
Indications and Usage
1 INDICATIONS AND USAGE AUSTEDO XR ® and AUSTEDO ® are indicated in adults for the treatment of: chorea associated with Huntington’s disease [see Clinical Studies ( 14.1 )] tardive dyskinesia [see Clinical Studies ( 14.2 )] AUSTEDO XR and AUSTEDO are vesicular monoamine transporter 2 (VMAT2) inhibitors indicated in adults for the treatment of: Chorea associated with Huntington’s disease ( 1 ) Tardive dyskinesia ( 1 )