NDC 67239-0209

Articaine HCl and Epinephrine

Articaine Hydrochloride And Epinephrine Bitartrate

Articaine HCl and Epinephrine is a Submucosal Injection in the Human Prescription Drug category. It is labeled and distributed by Safco Dental Supply Co.. The primary component is Articaine Hydrochloride; Epinephrine Bitartrate.

• Product ID: 67239-0209_68ba7502-e0f1-4ad1-a252-22d67127d4d8
• NDC: 67239-0209
• Product Type: Human Prescription Drug
• Proprietary Name: Articaine HCl and Epinephrine
• Generic Name: Articaine Hydrochloride And Epinephrine Bitartrate
• Dosage Form: Injection
• Route of Administration: SUBMUCOSAL
• Marketing Start Date: 2016-06-01
• Marketing Category: NDA / NDA
• Application Number: NDA022466
• Labeler Name: Safco Dental Supply Co.
• Substance Name: ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE
• Active Ingredient Strength: 40 mg/mL; ug/mL
• Pharm Classes: 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 Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 67239-0209-1

50 CARTRIDGE in 1 CARTON (67239-0209-1) > 1.8 mL in 1 CARTRIDGE

• Marketing Start Date: 2016-06-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 67239-0209-1 [67239020901]

Articaine HCl and Epinephrine INJECTION

• Marketing Category: NDA
• Application Number: NDA022466
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2016-06-01

Drug Details

Active Ingredients

Ingredient	Strength
ARTICAINE HYDROCHLORIDE	40 mg/mL

OpenFDA Data

• SPL SET ID: 0536a4de-578d-497e-a01b-0b1887344cc8
• Manufacturer:
  • Safco Dental Supply Co.
• UNII:
  • QS9014Q792
  • 30Q7KI53AK
• RxNorm Concept Unique ID - RxCUI:
  • 1658966
  • 1661483

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 HCl and Epinephrine" or generic name "Articaine Hydrochloride And Epinephrine Bitartrate"

NDC	Brand Name	Generic Name
67239-0209	Articaine HCl and Epinephrine	articaine hydrochloride and epinephrine bitartrate
67239-0210	Articaine HCl and Epinephrine	articaine hydrochloride and epinephrine bitartrate
66312-601	Articadent	Articaine hydrochloride and Epinephrine Bitartrate
66312-602	Articadent	Articaine hydrochloride and Epinephrine Bitartrate
45146-110	Orabloc	articaine hydrochloride and epinephrine bitartrate
45146-120	Orabloc	articaine hydrochloride and epinephrine bitartrate
0362-9048	Septocaine and Epinephrine	Articaine Hydrochloride and Epinephrine Bitartrate
0362-9049	Septocaine and Epinephrine	Articaine Hydrochloride and Epinephrine Bitartrate
31382-830	Zorcaine	Articaine hydrochloride and Epinephrine Bitartrate