Clobazam
- Product NDC
- 67877-658
- 11-digit product format
- 678770658
- Labeler code
- 67877
- Product ID
- 67877-658_fe56fe48-c21a-42ca-b82e-54c8ea178431
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Clobazam
- Dosage form
- SUSPENSION
- Route
- ORAL
- Labeler
- Ascend Laboratories, LLC
- Application
- ANDA213039
- Marketing category
- ANDA
- Marketing start
- 2021-05-07
- Substance
- CLOBAZAM
- Active strength
- 2.5 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Clobazam
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CLOBAZAM | 2.5 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 2MRO291B4U |
| Rxcui | 1366192 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 67877-658-61 | Clobazam | 1 in 1 CARTON | SUSPENSION | 1 | | 11 |
| 67877-658-61 | Clobazam | 120 mL in 1 BOTTLE | SUSPENSION | 120 | | 11 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 67877-658 | CLOBAZAM SUSPENSION [ASCEND LABORATORIES, LLC] | 11 | Current NDC, Legacy NDC, 2 package rows | 20241228_07e0ae51-cc71-427f-83cb-311b7fcc5993.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 67877-658-61 | 67877065861 | 1 BOTTLE in 1 CARTON (67877-658-61) / 120 mL in 1 BOTTLE | 1 bottle | 2021-05-07 | 0000-00-00 | No | No | Current |