Clobazam
- Product NDC
- 62135-527
- 11-digit product format
- 621350527
- Labeler code
- 62135
- Product ID
- 62135-527_181bd7dd-a848-7bc7-e063-6294a90a482c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Clobazam
- Dosage form
- SUSPENSION
- Route
- ORAL
- Labeler
- Chartwell RX, LLC
- Application
- ANDA213110
- Marketing category
- ANDA
- Marketing start
- 2020-04-24
- 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 |
|---|
| 62135-527-41 | Clobazam | 120 mL in 1 BOTTLE | SUSPENSION | 120 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 62135-527 | CLOBAZAM SUSPENSION [CHARTWELL RX, LLC] | 4 | Current NDC, Legacy NDC, 1 package rows | 20240511_17c3b9db-9e25-4a17-ac45-bcd17ea0360c.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 |
|---|
| 62135-527-41 | 62135052741 | 120 mL in 1 BOTTLE (62135-527-41) | 120 ml | 2022-08-01 | 0000-00-00 | No | No | Current |