Product NDC: | 63323-460 |
Proprietary Name: | SENSORCAINE |
Non Proprietary Name: | BUPIVACAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE |
Active Ingredient(s): | 7.5; .0091 mg/mL; mg/mL & nbsp; BUPIVACAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE |
Administration Route(s): | EPIDURAL; RETROBULBAR |
Dosage Form(s): | INJECTION, SOLUTION |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 63323-460 |
Labeler Name: | APP Pharmaceuticals, LLC |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | ANDA018304 |
Marketing Category: | ANDA |
Start Marketing Date: | 20101119 |
Package NDC: | 63323-460-37 |
Package Description: | 25 VIAL, SINGLE-DOSE in 1 CARTON (63323-460-37) > 30 mL in 1 VIAL, SINGLE-DOSE |
NDC Code | 63323-460-37 |
Proprietary Name | SENSORCAINE |
Package Description | 25 VIAL, SINGLE-DOSE in 1 CARTON (63323-460-37) > 30 mL in 1 VIAL, SINGLE-DOSE |
Product NDC | 63323-460 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | BUPIVACAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE |
Dosage Form Name | INJECTION, SOLUTION |
Route Name | EPIDURAL; RETROBULBAR |
Start Marketing Date | 20101119 |
Marketing Category Name | ANDA |
Labeler Name | APP Pharmaceuticals, LLC |
Substance Name | BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE |
Strength Number | 7.5; .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] |