Tetrabenazine
- Product NDC
- 0054-0468
- 11-digit product format
- 000540468
- Labeler code
- 0054
- Product ID
- 0054-0468_6fd34185-30a7-4c25-bd1d-1203858a3f2b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tetrabenazine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Hikma Pharmaceuticals USA Inc.
- Application
- ANDA209739
- Marketing category
- ANDA
- Marketing start
- 2019-09-19
- Marketing end
- 0000-00-00
- Substance
- TETRABENAZINE
- Active strength
- 13 mg/1
- Pharmacologic classes
- Vesicular Monoamine Transporter 2 Inhibitor [EPC],Vesicular Monoamine Transporter 2 Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0054-0468-23 | 00054046823 | 112 TABLET in 1 BOTTLE (0054-0468-23) | 112 tablet | 2019-09-19 | 0000-00-00 | No | No | Current |