Package 43498-816-01
Brand: articaine hydrochloride and epinephrine
Generic: articaine hydrochloride, epinephrine bitartratePackage Facts
Identity
Package NDC
43498-816-01
Digits Only
4349881601
Product NDC
43498-816
Description
50 CARTRIDGE in 1 BOX (43498-816-01) / 1.8 mL in 1 CARTRIDGE
Marketing
Marketing Status
Brand
articaine hydrochloride and epinephrine
Generic
articaine hydrochloride, epinephrine bitartrate
Sample Package
No
Linked Drug Pages (1)
Raw FDA Data
View complete raw FDA NDC JSON payload
{"route": ["SUBMUCOSAL"], "spl_id": "644fa9c3-1491-42e3-9194-9c562617fd06", "openfda": {"unii": ["30Q7KI53AK", "QS9014Q792"], "rxcui": ["1658966", "1661483"], "spl_set_id": ["4f11bb06-c71b-4d96-9baa-2a17ad473a05"], "manufacturer_name": ["Burkhart Dental Supply Co., Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "50 CARTRIDGE in 1 BOX (43498-816-01) / 1.8 mL in 1 CARTRIDGE", "package_ndc": "43498-816-01", "marketing_start_date": "20241104"}], "brand_name": "Articaine Hydrochloride and Epinephrine", "product_id": "43498-816_644fa9c3-1491-42e3-9194-9c562617fd06", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["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]"], "product_ndc": "43498-816", "generic_name": "ARTICAINE HYDROCHLORIDE, EPINEPHRINE BITARTRATE", "labeler_name": "Burkhart Dental Supply Co., Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Articaine Hydrochloride and Epinephrine", "active_ingredients": [{"name": "ARTICAINE HYDROCHLORIDE", "strength": "40 mg/mL"}, {"name": "EPINEPHRINE BITARTRATE", "strength": "10 ug/mL"}], "application_number": "NDA022466", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20241104", "listing_expiration_date": "20261231"}