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NDC 00378-8043-21 Clobazam 2.5 mg/mL Details
Clobazam 2.5 mg/mL
Clobazam is a ORAL SUSPENSION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Mylan Pharmaceuticals Inc.. The primary component is CLOBAZAM.
MedlinePlus Drug Summary
Clobazam is used with other medication(s) to control seizures in adults and children 2 years of age and older who have Lennox-Gastaut syndrome (a disorder that causes seizures and often causes developmental delays). Clobazam is in a class of medications called benzodiazepines. It works by decreasing abnormal electrical activity in the brain.
Related Packages: 00378-8043-21Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Clobazam
Product Information
| NDC | 00378-8043 |
|---|---|
| Product ID | 0378-8043_3c936088-7c62-43c1-8ebf-9dc6b61dd539 |
| Associated GPIs | 72100007001830 |
| GCN Sequence Number | 071282 |
| GCN Sequence Number Description | clobazam ORAL SUSP 2.5 MG/ML ORAL |
| HIC3 | H4A |
| HIC3 Description | ANTICONVULSANT - BENZODIAZEPINE TYPE |
| GCN | 35026 |
| HICL Sequence Number | 006536 |
| HICL Sequence Number Description | CLOBAZAM |
| Brand/Generic | Generic |
| Proprietary Name | Clobazam |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Clobazam |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | SUSPENSION |
| Route | ORAL |
| Active Ingredient Strength | 2.5 |
| Active Ingredient Units | mg/mL |
| Substance Name | CLOBAZAM |
| Labeler Name | Mylan Pharmaceuticals Inc. |
| Pharmaceutical Class | Benzodiazepine [EPC], Benzodiazepines [CS], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA] |
| DEA Schedule | CIV |
| Marketing Category | ANDA |
| Application Number | ANDA211259 |
| Listing Certified Through | 2023-12-31 |
Package
NDC 00378-8043-21 (00378804321)
| NDC Package Code | 0378-8043-21 |
|---|---|
| Billing NDC | 00378804321 |
| Package | 1 BOTTLE, GLASS in 1 CARTON (0378-8043-21) / 120 mL in 1 BOTTLE, GLASS |
| Marketing Start Date | 2018-11-07 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 0.37731 |
| Pricing Unit | ML |
| Effective Date | 2022-11-23 |
| NDC Description | CLOBAZAM 2.5 MG/ML SUSPENSION |
| Pharmacy Type Indicator | C/I |
| OTC | N |
| Explanation Code | 1, 5 |
| Classification for Rate Setting | G |
| As of Date | 2022-11-23 |
This pricing file, entitled the NADAC (National Average Drug Acquisition
Cost) files, provide
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