| Product NDC: | 0362-0101 |
| Proprietary Name: | Oraverse |
| Non Proprietary Name: | Phentolamine Mesylate |
| Active Ingredient(s): | .235 mg/mL & nbsp; Phentolamine Mesylate |
| Administration Route(s): | SUBMUCOSAL |
| Dosage Form(s): | INJECTION, SOLUTION |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 0362-0101 |
| Labeler Name: | Septodont, Inc. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA022159 |
| Marketing Category: | NDA |
| Start Marketing Date: | 20110601 |
| Package NDC: | 0362-0101-50 |
| Package Description: | 50 CARTRIDGE in 1 CARTON (0362-0101-50) > 1.7 mL in 1 CARTRIDGE |
| NDC Code | 0362-0101-50 |
| Proprietary Name | Oraverse |
| Package Description | 50 CARTRIDGE in 1 CARTON (0362-0101-50) > 1.7 mL in 1 CARTRIDGE |
| Product NDC | 0362-0101 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | Phentolamine Mesylate |
| Dosage Form Name | INJECTION, SOLUTION |
| Route Name | SUBMUCOSAL |
| Start Marketing Date | 20110601 |
| Marketing Category Name | NDA |
| Labeler Name | Septodont, Inc. |
| Substance Name | PHENTOLAMINE MESYLATE |
| Strength Number | .235 |
| Strength Unit | mg/mL |
| Pharmaceutical Classes | Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] |