| Product NDC: | 0409-7600 |
| Proprietary Name: | Bupivacaine Hydrochloride and Epinephrine |
| 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): | DENTAL; INFILTRATION |
| Dosage Form(s): | INJECTION, SOLUTION |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 0409-7600 |
| Labeler Name: | Hospira, Inc. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA022046 |
| Marketing Category: | NDA |
| Start Marketing Date: | 20110816 |
| Package NDC: | 0409-7600-01 |
| Package Description: | 50 CARTRIDGE in 1 CAN (0409-7600-01) > 1.8 mL in 1 CARTRIDGE |
| NDC Code | 0409-7600-01 |
| Proprietary Name | Bupivacaine Hydrochloride and Epinephrine |
| Package Description | 50 CARTRIDGE in 1 CAN (0409-7600-01) > 1.8 mL in 1 CARTRIDGE |
| Product NDC | 0409-7600 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | BUPIVACAINE HYDROCHLORIDE and EPINEPHRINE BITARTRATE |
| Dosage Form Name | INJECTION, SOLUTION |
| Route Name | DENTAL; INFILTRATION |
| Start Marketing Date | 20110816 |
| Marketing Category Name | NDA |
| Labeler Name | Hospira, 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] |