0404-6620 NDC - ARTICAINE HYDROCHLORIDE AND EPINEPHRINE ()

Drug Information

  • Product NDC: 0404-6620
  • Proprietary Name: Articaine Hydrochloride and Epinephrine
  • Non Proprietary Name:
  • Active Ingredient(s): 40 mg/mL ARTICAINE HYDROCHLORIDE; .01 mg/mL EPINEPHRINE BITARTRATE
  • Administration Route(s):
  • Dosage Form(s):
  • Pharmacy Class(es): 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]

Labeler Information

Field Name Field Value
Labeler Name: Henry Schein
Product Type:
FDA Application Number: NDA020971
Marketing Category: NDA
Start Marketing Date:12/12/2016
End Marketing Date:5/31/2019

Package Information

No. Package Code Package Description Billing Unit
10404-6620-0550 CARTRIDGE in 1 CARTON (0404-6620-05) / 1.7 mL in 1 CARTRIDGE
20404-6620-3030 SYRINGE in 1 CARTON (0404-6620-30) / 1 CARTRIDGE in 1 SYRINGE / 1.7 mL in 1 CARTRIDGE

NDC Record

Field Name Field Value Definition
PRODUCT NDC0404-6620The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PROPRIETARY NAMEArticaine Hydrochloride and EpinephrineThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
START MARKETING DATE12/12/2016This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMENDAProduct types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
APPLICATION NUMBERNDA020971This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
LABELER NAMEHenry ScheinName of Company corresponding to the labeler code segment of the Product NDC.
PRODUCT NDC0404-6620The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PROPRIETARY NAMEArticaine Hydrochloride and EpinephrineThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
START MARKETING DATE1/28/2015This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMENDA AUTHORIZED GENERICProduct types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
APPLICATION NUMBERNDA020971This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
LABELER NAMEHenry ScheinName of Company corresponding to the labeler code segment of the Product NDC.

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This page was last updated on: 11/21/2025

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