Tetrabenazine
- Product NDC
- 43598-394
- 11-digit product format
- 435980394
- Labeler code
- 43598
- Product ID
- 43598-394_b3ddb23f-3cc7-7c18-982b-970f7acc8766
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tetrabenazine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Dr. Reddys Laboratories Inc
- Application
- ANDA209284
- Marketing category
- ANDA
- Marketing start
- 2018-01-08
- 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 |
|---|
| 43598-394-05 | Tetrabenazine | 500 in 1 BOTTLE | TABLET | 500 | | 6 |
| 43598-394-67 | Tetrabenazine | 112 in 1 BOTTLE | TABLET | 112 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43598-394 | TETRABENAZINE TABLET [DR. REDDYS LABORATORIES INC] | 6 | Current NDC, Legacy NDC, 2 package rows | 20211130_ef5f9dd4-945f-ec27-518d-90996a7bd4b6.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 |
|---|
| 43598-394-05 | 43598039405 | 500 TABLET in 1 BOTTLE (43598-394-05) | 500 tablet | 2018-01-08 | 0000-00-00 | No | No | Current |
| 43598-394-67 | 43598039467 | 112 TABLET in 1 BOTTLE (43598-394-67) | 112 tablet | 2018-01-08 | 0000-00-00 | No | No | Current |