AUSTEDO XR
- Product NDC
- 68546-477
- 11-digit product format
- 685460477
- Labeler code
- 68546
- Product ID
- 68546-477_69071a25-792d-4eec-a12a-1bb30c8fc881
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- deutetrabenazine
- Dosage form
- KIT
- Labeler
- Teva Neuroscience, Inc.
- Application
- NDA216354
- Marketing category
- NDA
- Marketing start
- 2024-07-01
- 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 | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 68546-477-28 | 68546047728 | 1 KIT in 1 BLISTER PACK (68546-477-28) * 7 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (68546-192-07) * 7 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (68546-190-07) * 7 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (68546-193-07) * 7 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (68546-191-07) | 1 kit | 2024-07-01 | Yes | No | Historical |
| 68546-477-29 | 68546047729 | 1 BLISTER PACK in 1 CARTON (68546-477-29) / 1 KIT in 1 BLISTER PACK * 7 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (68546-192-07) * 7 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (68546-190-07) * 7 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (68546-193-07) * 7 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (68546-191-07) | 1 blister pack | 2024-07-01 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Austedo | Teva Neuroscience, Inc. | 2025-02-28 | HUMAN PRESCRIPTION DRUG LABEL | 35 |