Clobazam
- Product NDC
- 16714-087
- 11-digit product format
- 167140087
- Labeler code
- 16714
- Product ID
- 16714-087_f649cb16-8cb4-5292-e053-2995a90a04fc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Clobazam
- Dosage form
- SUSPENSION
- Route
- ORAL
- Labeler
- NorthStar RxLLC
- Application
- ANDA209796
- Marketing category
- ANDA
- Marketing start
- 2020-05-01
- 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 |
|---|
| 16714-087-01 | Clobazam | 1 in 1 CARTON | SUSPENSION | 1 | | 3 |
| 16714-087-01 | Clobazam | 120 mL in 1 BOTTLE, GLASS | SUSPENSION | 120 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 16714-087 | CLOBAZAM (CLOBAZAM) SUSPENSION [NORTHSTAR RXLLC] | 3 | Current NDC, Legacy NDC, 2 package rows | 20230308_574a3f91-d73e-46bc-b4a1-2388439521fb.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 |
|---|
| 16714-087-01 | 16714008701 | 1 BOTTLE, GLASS in 1 CARTON (16714-087-01) / 120 mL in 1 BOTTLE, GLASS | 2020-05-01 | 0000-00-00 | No | No | Current |