Product NDC: | 45146-120 |
Proprietary Name: | Orabloc |
Non Proprietary Name: | articaine hydrochloride and epinephrine bitartrate |
Active Ingredient(s): | 40; 5 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: | 45146-120 |
Labeler Name: | Pierrel S.p.A. |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | NDA022466 |
Marketing Category: | NDA |
Start Marketing Date: | 20110215 |
Package NDC: | 45146-120-02 |
Package Description: | 50 CARTRIDGE in 1 BOX (45146-120-02) > 1.8 mL in 1 CARTRIDGE |
NDC Code | 45146-120-02 |
Proprietary Name | Orabloc |
Package Description | 50 CARTRIDGE in 1 BOX (45146-120-02) > 1.8 mL in 1 CARTRIDGE |
Product NDC | 45146-120 |
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; 5 |
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] |