Package 43498-816-01

Brand: articaine hydrochloride and epinephrine

Generic: articaine hydrochloride, epinephrine bitartrate
NDC Package

Package 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
Marketed Since 2024-11-04
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"}