| Product NDC: | 0362-9011 |
| Proprietary Name: | Vivacaine |
| Non Proprietary Name: | bupivacaine hydrochloride and epinephrine bitartrate |
| Active Ingredient(s): | 5; .0091 mg/mL; mg/mL & nbsp; bupivacaine hydrochloride and epinephrine bitartrate |
| Administration Route(s): | SUBCUTANEOUS |
| Dosage Form(s): | INJECTION, SOLUTION |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 0362-9011 |
| Labeler Name: | Septodont Inc. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | ANDA077250 |
| Marketing Category: | ANDA |
| Start Marketing Date: | 20091217 |
| Package NDC: | 0362-9011-10 |
| Package Description: | 10 CARTRIDGE in 1 CARTON (0362-9011-10) > 1.7 mL in 1 CARTRIDGE |
| NDC Code | 0362-9011-10 |
| Proprietary Name | Vivacaine |
| Package Description | 10 CARTRIDGE in 1 CARTON (0362-9011-10) > 1.7 mL in 1 CARTRIDGE |
| Product NDC | 0362-9011 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | bupivacaine hydrochloride and epinephrine bitartrate |
| Dosage Form Name | INJECTION, SOLUTION |
| Route Name | SUBCUTANEOUS |
| Start Marketing Date | 20091217 |
| Marketing Category Name | ANDA |
| Labeler Name | Septodont Inc. |
| Substance Name | BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE |
| Strength Number | 5; .0091 |
| Strength Unit | mg/mL; mg/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] |