Tetrabenazine
- Product NDC
- 31722-821
- 11-digit product format
- 317220821
- Labeler code
- 31722
- Product ID
- 31722-821_3a2ffa8c-f4c5-47e2-8775-5d0edfa55658
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tetrabenazine
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- Camber Pharmaceuticals, Inc.
- Application
- ANDA204574
- Marketing category
- ANDA
- Marketing start
- 2015-08-17
- 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 |
|---|
| 31722-821-11 | Tetrabenazine | 112 in 1 BOTTLE | TABLET, COATED | 112 | | 3 |
| 31722-821-31 | Tetrabenazine | 10 in 1 BLISTER PACK | TABLET, COATED | 10 | | 3 |
| 31722-821-32 | Tetrabenazine | 100 in 1 CARTON | TABLET, COATED | 100 | | 3 |
| 31722-821-56 | Tetrabenazine | 56 in 1 BOTTLE | TABLET, COATED | 56 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 31722-821 | TETRABENAZINE TABLET, COATED [CAMBER PHARMACEUTICALS, INC.] | 3 | Current NDC, Legacy NDC, 4 package rows | 20180126_a03c3cf8-fcd4-4dbf-a4f5-59bd7887c902.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 31722-821-11 | 31722082111 | 112 TABLET, COATED in 1 BOTTLE (31722-821-11) | 2015-08-17 | 0000-00-00 | No | No | Current |
| 31722-821-31 | 31722082131 | 10 TABLET, COATED in 1 BLISTER PACK (31722-821-31) | 2015-08-17 | 0000-00-00 | No | No | Current |
| 31722-821-32 | 31722082132 | 100 TABLET, COATED in 1 CARTON (31722-821-32) | 2015-08-17 | 0000-00-00 | No | No | Current |
| 31722-821-56 | 31722082156 | 56 TABLET, COATED in 1 BOTTLE (31722-821-56) | 2015-08-17 | 0000-00-00 | No | No | Current |