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] |