Clobazam
- Product NDC
- 67877-664
- 11-digit product format
- 678770664
- Labeler code
- 67877
- Product ID
- 67877-664_f9dc8ac4-86be-49ab-9c2c-c60658f49d8f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Clobazam
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Ascend Laboratories, LLC
- Application
- ANDA212714
- Marketing category
- ANDA
- Marketing start
- 2023-10-18
- Substance
- CLOBAZAM
- Active strength
- 5 mg/1
- 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
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 2MRO291B4U | CLOBAZAM | 22316-47-8 | CLOBAZAM |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 67877-664-01 | 67877066401 | 1 BOTTLE in 1 CARTON (67877-664-01) / 100 TABLET in 1 BOTTLE | 1 bottle | 2023-10-18 | No | No | Historical |
| 67877-664-05 | 67877066405 | 500 TABLET in 1 BOTTLE (67877-664-05) | 500 tablet | 2023-10-18 | No | No | Historical |
| 67877-664-33 | 67877066433 | 1 BLISTER PACK in 1 CARTON (67877-664-33) / 10 TABLET in 1 BLISTER PACK | 1 blister pack | 2023-10-18 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Clobazam | Ascend Laboratories, LLC | Alkem Laboratories Limited | 2025-06-10 | Human Prescription Drug Label | 18 |