| Product NDC: | 67386-313 |
| Proprietary Name: | Onfi |
| Non Proprietary Name: | clobazam |
| Active Ingredient(s): | 2.5 mg/mL & nbsp; clobazam |
| Administration Route(s): | ORAL |
| Dosage Form(s): | SUSPENSION |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 67386-313 |
| Labeler Name: | Lundbeck LLC |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA203993 |
| Marketing Category: | NDA |
| Start Marketing Date: | 20121214 |
| Package NDC: | 67386-313-21 |
| Package Description: | 1 BOTTLE in 1 CARTON (67386-313-21) > 120 mL in 1 BOTTLE |
| NDC Code | 67386-313-21 |
| Proprietary Name | Onfi |
| Package Description | 1 BOTTLE in 1 CARTON (67386-313-21) > 120 mL in 1 BOTTLE |
| Product NDC | 67386-313 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | clobazam |
| Dosage Form Name | SUSPENSION |
| Route Name | ORAL |
| Start Marketing Date | 20121214 |
| Marketing Category Name | NDA |
| Labeler Name | Lundbeck LLC |
| Substance Name | CLOBAZAM |
| Strength Number | 2.5 |
| Strength Unit | mg/mL |
| Pharmaceutical Classes | Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient],Cytochrome P450 2D6 Inhibitors [MoA] |