Product NDC: | 63323-489 |
Proprietary Name: | Xylocaine |
Non Proprietary Name: | LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE |
Active Ingredient(s): | .005; 20 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: | 63323-489 |
Labeler Name: | APP Pharmaceuticals, LLC |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | NDA006488 |
Marketing Category: | NDA |
Start Marketing Date: | 20100812 |
Package NDC: | 63323-489-27 |
Package Description: | 25 VIAL, SINGLE-DOSE in 1 CARTON (63323-489-27) > 20 mL in 1 VIAL, SINGLE-DOSE |
NDC Code | 63323-489-27 |
Proprietary Name | Xylocaine |
Package Description | 25 VIAL, SINGLE-DOSE in 1 CARTON (63323-489-27) > 20 mL in 1 VIAL, SINGLE-DOSE |
Product NDC | 63323-489 |
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; 20 |
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] |