NDC 66312-601

Articadent

Articaine Hydrochloride And Epinephrine Bitartrate

Articadent is a Submucosal Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Dentsply Pharmaceutical. The primary component is Articaine Hydrochloride; Epinephrine Bitartrate.

• Product ID: 66312-601_5bc1c082-332c-21da-e053-2a91aa0ab84b
• NDC: 66312-601
• Product Type: Human Prescription Drug
• Proprietary Name: Articadent
• Generic Name: Articaine Hydrochloride And Epinephrine Bitartrate
• Dosage Form: Injection, Solution
• Route of Administration: SUBMUCOSAL
• Marketing Start Date: 2000-04-03
• Marketing Category: ANDA / ANDA
• Application Number: ANDA020971
• Labeler Name: Dentsply Pharmaceutical
• Substance Name: ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE
• Active Ingredient Strength: 40 mg/mL; mg/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 66312-601-16

50 CARTRIDGE in 1 CARTON (66312-601-16) > 1.7 mL in 1 CARTRIDGE

• Marketing Start Date: 2000-04-03
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 66312-601-16 [66312060116]

Articadent INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA020971
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2000-04-03

Drug Details

Active Ingredients

Ingredient	Strength
ARTICAINE HYDROCHLORIDE	40 mg/mL

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 "Articadent" or generic name "Articaine Hydrochloride And Epinephrine Bitartrate"

NDC	Brand Name	Generic Name
66312-601	Articadent	Articaine hydrochloride and Epinephrine Bitartrate
66312-602	Articadent	Articaine hydrochloride and Epinephrine Bitartrate
67239-0209	Articaine HCl and Epinephrine	articaine hydrochloride and epinephrine bitartrate
67239-0210	Articaine HCl and Epinephrine	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