| Product NDC: | 63323-487 |
| Proprietary Name: | Xylocaine |
| Non Proprietary Name: | LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE |
| Active Ingredient(s): | .005; 10 mg/mL; mg/mL & nbsp; LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE |
| Administration Route(s): | EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL |
| Dosage Form(s): | INJECTION, SOLUTION |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 63323-487 |
| Labeler Name: | APP Pharmaceuticals, LLC |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA006488 |
| Marketing Category: | NDA |
| Start Marketing Date: | 20100812 |
| Package NDC: | 63323-487-17 |
| Package Description: | 25 VIAL, SINGLE-DOSE in 1 CARTON (63323-487-17) > 10 mL in 1 VIAL, SINGLE-DOSE |
| NDC Code | 63323-487-17 |
| Proprietary Name | Xylocaine |
| Package Description | 25 VIAL, SINGLE-DOSE in 1 CARTON (63323-487-17) > 10 mL in 1 VIAL, SINGLE-DOSE |
| Product NDC | 63323-487 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE |
| Dosage Form Name | INJECTION, SOLUTION |
| Route Name | EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL |
| Start Marketing Date | 20100812 |
| Marketing Category Name | NDA |
| Labeler Name | APP Pharmaceuticals, LLC |
| Substance Name | EPINEPHRINE BITARTRATE; LIDOCAINE HYDROCHLORIDE |
| Strength Number | .005; 10 |
| Strength Unit | mg/mL; mg/mL |
| Pharmaceutical Classes | Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] |