| Product NDC: | 45146-110 |
| Proprietary Name: | Orabloc |
| Non Proprietary Name: | articaine hydrochloride and epinephrine bitartrate |
| Active Ingredient(s): | 40; 10 mg/mL; ug/mL & nbsp; articaine hydrochloride and epinephrine bitartrate |
| Administration Route(s): | SUBMUCOSAL |
| Dosage Form(s): | INJECTION |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 45146-110 |
| Labeler Name: | Pierrel S.p.A. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA022466 |
| Marketing Category: | NDA |
| Start Marketing Date: | 20110215 |
| Package NDC: | 45146-110-02 |
| Package Description: | 50 CARTRIDGE in 1 BOX (45146-110-02) > 1.8 mL in 1 CARTRIDGE |
| NDC Code | 45146-110-02 |
| Proprietary Name | Orabloc |
| Package Description | 50 CARTRIDGE in 1 BOX (45146-110-02) > 1.8 mL in 1 CARTRIDGE |
| Product NDC | 45146-110 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | articaine hydrochloride and epinephrine bitartrate |
| Dosage Form Name | INJECTION |
| Route Name | SUBMUCOSAL |
| Start Marketing Date | 20110215 |
| Marketing Category Name | NDA |
| Labeler Name | Pierrel S.p.A. |
| Substance Name | ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE |
| Strength Number | 40; 10 |
| Strength Unit | mg/mL; ug/mL |
| Pharmaceutical Classes | Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] |