AUSTEDO XR
- Product NDC
- 68546-476
- 11-digit product format
- 685460476
- Labeler code
- 68546
- Product ID
- 68546-476_69071a25-792d-4eec-a12a-1bb30c8fc881
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- deutetrabenazine
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Teva Neuroscience, Inc.
- Application
- NDA216354
- Marketing category
- NDA
- Marketing start
- 2024-05-29
- Substance
- DEUTETRABENAZINE
- Active strength
- 48 mg/1
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| P341G6W9NB | DEUTETRABENAZINE | 1392826-25-3 | DEUTETRABENAZINE |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 68546-476-56 | 68546047656 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68546-476-56) | 2024-05-29 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Austedo | Teva Neuroscience, Inc. | 2025-02-28 | HUMAN PRESCRIPTION DRUG LABEL | 35 |