clobazam
- Product NDC
- 0054-0561
- 11-digit product format
- 000540561
- Labeler code
- 0054
- Product ID
- 0054-0561_f1596a5e-5f83-46bd-9c26-e8260f92e44a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- clobazam
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Hikma Pharmaceuticals USA Inc.
- Application
- ANDA209715
- Marketing category
- ANDA
- Marketing start
- 2018-10-22
- Marketing end
- 0000-00-00
- Substance
- CLOBAZAM
- Active strength
- 3 mg/mL
- Pharmacologic classes
- Benzodiazepine [EPC], Benzodiazepines [CS], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA]
- DEA schedule
- CIV
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- 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 |
|---|
| 0054-0561-50 | 00054056150 | 1 BOTTLE in 1 CARTON (0054-0561-50) > 120 mL in 1 BOTTLE | 1 bottle | 2018-10-22 | 0000-00-00 | No | No | Current |