| NDC Code | 43498-993-01 |
| Package Description | 50 CARTRIDGE in 1 BOX (43498-993-01) / 1.8 mL in 1 CARTRIDGE |
| Product NDC | 43498-993 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Proprietary Name | Articaine Hydrochloride And Epinephrine |
| Non-Proprietary Name | Articaine Hydrochloride, Epinephrine Bitartrate |
| Dosage Form | INJECTION, SOLUTION |
| Usage | SUBMUCOSAL |
| Start Marketing Date | 20241104 |
| Marketing Category Name | NDA AUTHORIZED GENERIC |
| Application Number | NDA022466 |
| Manufacturer | Burkhart Dental Supply Co., Inc |
| Substance Name | ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE |
| Strength | 40; 5 |
| Strength Unit | mg/mL; ug/mL |
| Pharmacy Classes | Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Amide Local Anesthetic [EPC], Amides [CS], Catecholamine [EPC], Catecholamines [CS], Local Anesthesia [PE], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC] |