NDC 50227-1040

ARTICAINE

Articaine Hydrochloride And Epinephrine

ARTICAINE is a Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Patterson Dental. The primary component is Articaine Hydrochloride; Epinephrine Bitartrate.

Product ID50227-1040_13718354-387a-43e3-9dd1-b062d19dfc78
NDC50227-1040
Product TypeHuman Prescription Drug
Proprietary NameARTICAINE
Generic NameArticaine Hydrochloride And Epinephrine
Dosage FormInjection, Solution
Route of AdministrationSUBCUTANEOUS
Marketing Start Date2014-12-22
Marketing CategoryNDA / NDA
Application NumberNDA020971
Labeler NamePatterson Dental
Substance NameARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE
Active Ingredient Strength40 mg/mL; mg/mL
Pharm ClassesAmide Local Anesthetic [EPC],Amides [CS],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [CS]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 50227-1040-5

50 CARTRIDGE in 1 CARTON (50227-1040-5) > 1.7 mL in 1 CARTRIDGE
Marketing Start Date2014-12-22
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50227-1040-5 [50227104005]

ARTICAINE INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA020971
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-12-22

Drug Details

Active Ingredients

IngredientStrength
ARTICAINE HYDROCHLORIDE40 mg/mL

OpenFDA Data

SPL SET ID:406de6e6-40f5-44c5-a109-3be0b9d48e58
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1595035

    • Pharmacological Class

    • Amide Local Anesthetic [EPC]
    • Amides [CS]
    • Local Anesthesia [PE]
    • Adrenergic alpha-Agonists [MoA]
    • Adrenergic beta-Agonists [MoA]
    • alpha-Adrenergic Agonist [EPC]
    • beta-Adrenergic Agonist [EPC]
    • Catecholamine [EPC]
    • Catecholamines [CS]

    NDC Crossover Matching brand name "ARTICAINE" or generic name "Articaine Hydrochloride And Epinephrine"

    NDCBrand NameGeneric Name
    43128-101ARTICAINEArticaine Hydrochloride and Epinephrine
    43128-102ARTICAINEArticaine Hydrochloride and Epinephrine
    50227-1040ARTICAINEArticaine Hydrochloride and Epinephrine
    50227-1050ARTICAINEArticaine Hydrochloride and Epinephrine
    66975-417ARTICAINEArticaine Hydrochloride and Epinephrine
    66975-418ARTICAINEArticaine Hydrochloride and Epinephrine
    0404-6620Articaine Hydrochloride and EpinephrineArticaine Hydrochloride and Epinephrine
    0404-6625Articaine Hydrochloride and EpinephrineArticaine Hydrochloride and Epinephrine
    0362-0830ZorcaineArticaine Hydrochloride and Epinephrine
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