Clobazam
- Product NDC
- 0378-8043
- 11-digit product format
- 003788043
- Labeler code
- 0378
- Product ID
- 0378-8043_3c936088-7c62-43c1-8ebf-9dc6b61dd539
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Clobazam
- Dosage form
- SUSPENSION
- Route
- ORAL
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- ANDA211259
- Marketing category
- ANDA
- Marketing start
- 2018-11-07
- 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 | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0378-8043-21 | 00378804321 | 1 BOTTLE, GLASS in 1 CARTON (0378-8043-21) > 120 mL in 1 BOTTLE, GLASS | 2018-11-07 | 0000-00-00 | No | No | Current |