articaine hydrochloride and epinephrine

Generic: articaine hydrochloride, epinephrine bitartrate

Labeler: burkhart dental supply co., inc
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name articaine hydrochloride and epinephrine
Generic Name articaine hydrochloride, epinephrine bitartrate
Labeler burkhart dental supply co., inc
Dosage Form INJECTION, SOLUTION
Routes
SUBMUCOSAL
Active Ingredients

articaine hydrochloride 40 mg/mL, epinephrine bitartrate 10 ug/mL

Manufacturer
Burkhart Dental Supply Co., Inc

Identifiers & Regulatory

Product NDC 43498-816
Product ID 43498-816_644fa9c3-1491-42e3-9194-9c562617fd06
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA022466
Listing Expiration 2026-12-31
Marketing Start 2024-11-04

Pharmacologic Class

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]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 43498816
Hyphenated Format 43498-816

Supplemental Identifiers

RxCUI
1658966 1661483
UNII
30Q7KI53AK QS9014Q792

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name articaine hydrochloride and epinephrine (source: ndc)
Generic Name articaine hydrochloride, epinephrine bitartrate (source: ndc)
Application Number NDA022466 (source: ndc)
Routes
SUBMUCOSAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/mL
  • 10 ug/mL
source: ndc
Packaging
  • 50 CARTRIDGE in 1 BOX (43498-816-01) / 1.8 mL in 1 CARTRIDGE
source: ndc

Packages (1)

43498-816-01 50 CARTRIDGE in 1 BOX (43498-816-01) / 1.8 mL in 1 CARTRIDGE

Ingredients (2)

articaine hydrochloride (40 mg/mL) epinephrine bitartrate (10 ug/mL)

Linked Drug Pages (1)

Articaine Hydrochloride and Epinephrine ndc-match (0.9)

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"}