Clobazam
- Product NDC
- 69238-1535
- 11-digit product format
- 692381535
- Labeler code
- 69238
- Product ID
- 69238-1535_cf085b2b-564e-4109-90e7-1d27fcbca810
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Clobazam
- Dosage form
- SUSPENSION
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals NY LLC
- Application
- ANDA210039
- Marketing category
- ANDA
- Marketing start
- 2018-10-22
- 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 |
|---|
| 69238-1535-2 | Clobazam | 120 mL in 1 BOTTLE, GLASS | SUSPENSION | 120 | | 19 |
| 69238-1535-2 | Clobazam | 1 in 1 CARTON | SUSPENSION | 1 | | 19 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69238-1535 | CLOBAZAM SUSPENSION [AMNEAL PHARMACEUTICALS NY LLC] | 19 | Current NDC, Legacy NDC, 2 package rows | 20240713_a526ad73-d3c1-40b7-8e71-426b01cdea27.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 69238-1535-2 | 69238153502 | 1 BOTTLE, GLASS in 1 CARTON (69238-1535-2) / 120 mL in 1 BOTTLE, GLASS | 2018-10-22 | 0000-00-00 | No | No | Current |