Tetrabenazine
- Product NDC
- 68094-905
- 11-digit product format
- 680940905
- Labeler code
- 68094
- Product ID
- 68094-905_aca55884-1eb4-4a76-8c7f-96c782849337
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- TETRABENAZINE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Precision Dose Inc.
- Application
- ANDA207682
- Marketing category
- ANDA
- Marketing start
- 2023-12-01
- 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 |
|---|
| 68094-905-10 | Tetrabenazine | 112 in 1 BOTTLE, PLASTIC | TABLET | 112 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68094-905 | TETRABENAZINE TABLET [PRECISION DOSE INC.] | 1 | Current NDC, 1 package rows | 20231202_aca55884-1eb4-4a76-8c7f-96c782849337.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 68094-905-10 | 68094090510 | 112 TABLET in 1 BOTTLE, PLASTIC (68094-905-10) | 112 tablet | 2023-12-01 | No | No | Current |