articaine

Generic: articaine hydrochloride and epinephrine

Labeler: ndc, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name articaine
Generic Name articaine hydrochloride and epinephrine
Labeler ndc, inc.
Dosage Form INJECTION, SOLUTION
Routes
SUBMUCOSAL
Active Ingredients

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

Manufacturer
NDC, Inc.

Identifiers & Regulatory

Product NDC 43128-101
Product ID 43128-101_95650cb2-1026-4d7a-aac0-7bfb0ac4a2f2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA020971
Listing Expiration 2026-12-31
Marketing Start 2015-06-22

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 43128101
Hyphenated Format 43128-101

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 (43128-101-05) / 1.7 mL in 1 CARTRIDGE
source: ndc

Packages (1)

43128-101-05 50 CARTRIDGE in 1 CARTON (43128-101-05) / 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": "95650cb2-1026-4d7a-aac0-7bfb0ac4a2f2", "openfda": {"unii": ["QS9014Q792", "30Q7KI53AK"], "rxcui": ["1595035"], "spl_set_id": ["0b0cbbec-8216-434f-892e-226c89d7239c"], "manufacturer_name": ["NDC, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "50 CARTRIDGE in 1 CARTON (43128-101-05)  / 1.7 mL in 1 CARTRIDGE", "package_ndc": "43128-101-05", "marketing_start_date": "20150622"}], "brand_name": "ARTICAINE", "product_id": "43128-101_95650cb2-1026-4d7a-aac0-7bfb0ac4a2f2", "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": "43128-101", "generic_name": "Articaine Hydrochloride and Epinephrine", "labeler_name": "NDC, Inc.", "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": "20150622", "listing_expiration_date": "20261231"}