articaine hydrochloride and epinephrine

Generic: articaine hydrochloride and epinephrine

Labeler: henry schein
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

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

articaine hydrochloride 40 mg/mL, epinephrine bitartrate .005 mg/mL

Manufacturer
Henry Schein

Identifiers & Regulatory

Product NDC 0404-6625
Product ID 0404-6625_67eba8ba-c8c4-43f5-a482-88e4c0c355a8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA020971
Listing Expiration 2026-12-31
Marketing Start 2014-01-28

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 04046625
Hyphenated Format 0404-6625

Supplemental Identifiers

RxCUI
1595029 1595035
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 and epinephrine (source: ndc)
Application Number NDA020971 (source: ndc)
Routes
SUBMUCOSAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/mL
  • .005 mg/mL
source: ndc
Packaging
  • 50 CARTRIDGE in 1 CARTON (0404-6625-05) / 1.7 mL in 1 CARTRIDGE
source: ndc

Packages (1)

0404-6625-05 50 CARTRIDGE in 1 CARTON (0404-6625-05) / 1.7 mL in 1 CARTRIDGE

Ingredients (2)

articaine hydrochloride (40 mg/mL) epinephrine bitartrate (.005 mg/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": "67eba8ba-c8c4-43f5-a482-88e4c0c355a8", "openfda": {"unii": ["30Q7KI53AK", "QS9014Q792"], "rxcui": ["1595029", "1595035"], "spl_set_id": ["d9402ac2-fedd-4fb0-90a3-2c466a786526"], "manufacturer_name": ["Henry Schein"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "50 CARTRIDGE in 1 CARTON (0404-6625-05)  / 1.7 mL in 1 CARTRIDGE", "package_ndc": "0404-6625-05", "marketing_start_date": "20140128"}], "brand_name": "Articaine Hydrochloride and Epinephrine", "product_id": "0404-6625_67eba8ba-c8c4-43f5-a482-88e4c0c355a8", "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": "0404-6625", "generic_name": "Articaine Hydrochloride and Epinephrine", "labeler_name": "Henry Schein", "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": ".005 mg/mL"}], "application_number": "NDA020971", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20140128", "listing_expiration_date": "20261231"}