articadent

Generic: articaine hydrochloride and epinephrine bitartrate

Labeler: dentsply pharmaceutical
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name articadent
Generic Name articaine hydrochloride and epinephrine bitartrate
Labeler dentsply pharmaceutical
Dosage Form INJECTION, SOLUTION
Routes
SUBMUCOSAL
Active Ingredients

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

Manufacturer
Dentsply Pharmaceutical

Identifiers & Regulatory

Product NDC 66312-601
Product ID 66312-601_7b56ec0a-5b85-4069-a3b2-94654644aaa4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA020971
Listing Expiration 2026-12-31
Marketing Start 2009-09-01

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 66312601
Hyphenated Format 66312-601

Supplemental Identifiers

RxCUI
1011646 1011648 1595029 1595035
UPC
0000004235644
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 articadent (source: ndc)
Generic Name articaine hydrochloride and epinephrine bitartrate (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 (66312-601-16) / 1.7 mL in 1 CARTRIDGE
source: ndc

Packages (1)

66312-601-16 50 CARTRIDGE in 1 CARTON (66312-601-16) / 1.7 mL in 1 CARTRIDGE

Ingredients (2)

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

Linked Drug Pages (1)

Articadent ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBMUCOSAL"], "spl_id": "7b56ec0a-5b85-4069-a3b2-94654644aaa4", "openfda": {"upc": ["0000004235644"], "unii": ["30Q7KI53AK", "QS9014Q792"], "rxcui": ["1011646", "1011648", "1595029", "1595035"], "spl_set_id": ["9ca8fb43-4f34-47c0-8b79-3b5bd1eaee00"], "manufacturer_name": ["Dentsply Pharmaceutical"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "50 CARTRIDGE in 1 CARTON (66312-601-16)  / 1.7 mL in 1 CARTRIDGE", "package_ndc": "66312-601-16", "marketing_start_date": "20090901"}], "brand_name": "Articadent", "product_id": "66312-601_7b56ec0a-5b85-4069-a3b2-94654644aaa4", "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": "66312-601", "generic_name": "Articaine hydrochloride and Epinephrine Bitartrate", "labeler_name": "Dentsply Pharmaceutical", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Articadent", "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": "20090901", "listing_expiration_date": "20261231"}