| Product NDC: | 31382-557 |
| Proprietary Name: | Marcaine |
| Non Proprietary Name: | bupivacaine hydrochloride and epinephrine bitartrate |
| Active Ingredient(s): | 5; .005 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: | 31382-557 |
| Labeler Name: | Carestream Health Inc. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | ANDA077250 |
| Marketing Category: | ANDA |
| Start Marketing Date: | 20130601 |
| Package NDC: | 31382-557-05 |
| Package Description: | 50 CARTRIDGE in 1 CARTON (31382-557-05) > 1.8 mL in 1 CARTRIDGE |
| NDC Code | 31382-557-05 |
| Proprietary Name | Marcaine |
| Package Description | 50 CARTRIDGE in 1 CARTON (31382-557-05) > 1.8 mL in 1 CARTRIDGE |
| Product NDC | 31382-557 |
| 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 | 20130601 |
| Marketing Category Name | ANDA |
| Labeler Name | Carestream Health Inc. |
| Substance Name | BUPIVACAINE HYDROCHLORIDE ANHYDROUS; EPINEPHRINE BITARTRATE |
| Strength Number | 5; .005 |
| Strength Unit | mg/mL; mg/mL |
| Pharmaceutical Classes | Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient],Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] |