articaine

Generic: articaine hydrochloride and epinephrine

Labeler: benco dental
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name articaine
Generic Name articaine hydrochloride and epinephrine
Labeler benco dental
Dosage Form INJECTION, SOLUTION
Routes
SUBMUCOSAL
Active Ingredients

articaine hydrochloride 40 mg/mL, epinephrine bitartrate .01 mg/mL

Manufacturer
Benco Dental

Identifiers & Regulatory

Product NDC 66975-417
Product ID 66975-417_4c144938-6d29-4641-b723-b8522bb11879
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA020971
Listing Expiration 2026-12-31
Marketing Start 2016-04-04

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 66975417
Hyphenated Format 66975-417

Supplemental Identifiers

RxCUI
1595035
UNII
QS9014Q792 30Q7KI53AK

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 (source: ndc)
Generic Name articaine hydrochloride and epinephrine (source: ndc)
Application Number NDA020971 (source: ndc)
Routes
SUBMUCOSAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/mL
  • .01 mg/mL
source: ndc
Packaging
  • 50 CARTRIDGE in 1 CARTON (66975-417-51) / 1.7 mL in 1 CARTRIDGE
source: ndc

Packages (1)

66975-417-51 50 CARTRIDGE in 1 CARTON (66975-417-51) / 1.7 mL in 1 CARTRIDGE

Ingredients (2)

articaine hydrochloride (40 mg/mL) epinephrine bitartrate (.01 mg/mL)

Linked Drug Pages (1)

ARTICAINE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBMUCOSAL"], "spl_id": "4c144938-6d29-4641-b723-b8522bb11879", "openfda": {"unii": ["QS9014Q792", "30Q7KI53AK"], "rxcui": ["1595035"], "spl_set_id": ["d47d7842-930e-41db-9631-d1aba0f05ae0"], "manufacturer_name": ["Benco Dental"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "50 CARTRIDGE in 1 CARTON (66975-417-51)  / 1.7 mL in 1 CARTRIDGE", "package_ndc": "66975-417-51", "marketing_start_date": "20160404"}], "brand_name": "ARTICAINE", "product_id": "66975-417_4c144938-6d29-4641-b723-b8522bb11879", "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": "66975-417", "generic_name": "Articaine Hydrochloride and Epinephrine", "labeler_name": "Benco Dental", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ARTICAINE", "active_ingredients": [{"name": "ARTICAINE HYDROCHLORIDE", "strength": "40 mg/mL"}, {"name": "EPINEPHRINE BITARTRATE", "strength": ".01 mg/mL"}], "application_number": "NDA020971", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20160404", "listing_expiration_date": "20261231"}