Xenazine
- Product NDC
- 67386-421
- 11-digit product format
- 673860421
- Labeler code
- 67386
- Product ID
- 67386-421_6f524695-2fc1-4c54-9212-69cff22cdfa7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- tetrabenazine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Lundbeck Pharmaceuticals LLC
- Application
- NDA021894
- Marketing category
- NDA
- Marketing start
- 2008-11-24
- Substance
- TETRABENAZINE
- Active strength
- 12.5 mg/1
- Pharmacologic classes
- Vesicular Monoamine Transporter 2 Inhibitor [EPC], Vesicular Monoamine Transporter 2 Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Xenazine
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| TETRABENAZINE | 12.5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | Z9O08YRN8O |
| Rxcui | 199592, 805462, 805464, 805466 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 67386-421-01 | Xenazine | 112 in 1 BOTTLE | TABLET | 112 | | 21 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 67386-421 | XENAZINE (TETRABENAZINE) TABLET [LUNDBECK PHARMACEUTICALS LLC] | 21 | Current NDC, Legacy NDC, 1 package rows | 20220805_ac768bab-8afa-4446-bc7f-caeeffec0cda.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 67386-421-01 | 67386042101 | 112 TABLET in 1 BOTTLE (67386-421-01) | 112 tablet | 2008-11-24 | 0000-00-00 | No | No | Current |