| Product NDC: | 0404-6620 |
| Proprietary Name: | Articaine Hydrochloride and Epinephrine Bitartrate |
| Non Proprietary Name: | Articaine Hydrochloride and Epinephrine Bitartrate |
| Active Ingredient(s): | 40; .01 mg/mL; mg/mL & nbsp; Articaine Hydrochloride and Epinephrine Bitartrate |
| Administration Route(s): | SUBCUTANEOUS |
| Dosage Form(s): | INJECTION, SOLUTION |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 0404-6620 |
| Labeler Name: | Henry Schein Inc. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA020971 |
| Marketing Category: | NDA |
| Start Marketing Date: | 20100827 |
| Package NDC: | 0404-6620-05 |
| Package Description: | 50 CARTRIDGE in 1 CARTON (0404-6620-05) > 1.7 mL in 1 CARTRIDGE |
| NDC Code | 0404-6620-05 |
| Proprietary Name | Articaine Hydrochloride and Epinephrine Bitartrate |
| Package Description | 50 CARTRIDGE in 1 CARTON (0404-6620-05) > 1.7 mL in 1 CARTRIDGE |
| Product NDC | 0404-6620 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | Articaine Hydrochloride and Epinephrine Bitartrate |
| Dosage Form Name | INJECTION, SOLUTION |
| Route Name | SUBCUTANEOUS |
| Start Marketing Date | 20100827 |
| Marketing Category Name | NDA |
| Labeler Name | Henry Schein Inc. |
| Substance Name | ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE |
| Strength Number | 40; .01 |
| 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] |