tetrabenazine
- Product NDC
- 70436-101
- 11-digit product format
- 704360101
- Labeler code
- 70436
- Product ID
- 70436-101_de4c0693-1b76-4026-bd94-a7a5dcc8a376
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- tetrabenazine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Slate Run Pharmaceuticals, LLC
- Application
- ANDA213316
- Marketing category
- ANDA
- Marketing start
- 2020-03-02
- 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
- tetrabenazine
- 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, 805464 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70436-101-09 | tetrabenazine | 112 in 1 BOTTLE | TABLET | 112 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70436-101 | TETRABENAZINE TABLET [SLATE RUN PHARMACEUTICALS, LLC] | 2 | Current NDC, Legacy NDC, 1 package rows | 20210303_49587379-1cc0-48ff-9f2f-517079cf499d.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 |
|---|
| 70436-101-09 | 70436010109 | 112 TABLET in 1 BOTTLE (70436-101-09) | 112 tablet | 2020-03-02 | 0000-00-00 | No | No | Current |