NDC 0362-0830

Zorcaine

Articaine Hydrochloride And Epinephrine

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

• Product ID: 0362-0830_0942bc27-84c4-4c4c-b1dc-c9efb566ebdc
• NDC: 0362-0830
• Product Type: Human Prescription Drug
• Proprietary Name: Zorcaine
• Generic Name: Articaine Hydrochloride And Epinephrine
• Dosage Form: Injection, Solution
• Route of Administration: SUBCUTANEOUS
• Marketing Start Date: 2019-04-05
• Marketing Category: NDA / NDA
• Application Number: NDA020971
• Labeler Name: Septodont, Inc.
• 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: 2020-12-31

Packaging

NDC 0362-0830-05

50 CARTRIDGE in 1 CARTON (0362-0830-05) > 1.7 mL in 1 CARTRIDGE

• Marketing Start Date: 2019-04-05
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0362-0830-05 [00362083005]

Zorcaine INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA020971
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-04-05

Drug Details

Active Ingredients

Ingredient	Strength
ARTICAINE HYDROCHLORIDE	40 mg/mL

OpenFDA Data

• SPL SET ID: 1767d606-69b8-419e-840f-36550ed91b8f
• Manufacturer:
  • Septodont, Inc.
• UNII:
  • QS9014Q792
  • 30Q7KI53AK
• RxNorm Concept Unique ID - RxCUI:
  • 861592
  • 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 "Zorcaine" or generic name "Articaine Hydrochloride And Epinephrine"

NDC	Brand Name	Generic Name
0362-0830	Zorcaine	Articaine Hydrochloride and Epinephrine
31382-830	Zorcaine	Articaine hydrochloride and Epinephrine Bitartrate
43128-101	ARTICAINE	Articaine Hydrochloride and Epinephrine
43128-102	ARTICAINE	Articaine Hydrochloride and Epinephrine
50227-1040	ARTICAINE	Articaine Hydrochloride and Epinephrine
50227-1050	ARTICAINE	Articaine Hydrochloride and Epinephrine
66975-417	ARTICAINE	Articaine Hydrochloride and Epinephrine
66975-418	ARTICAINE	Articaine Hydrochloride and Epinephrine
0404-6620	Articaine Hydrochloride and Epinephrine	Articaine Hydrochloride and Epinephrine
0404-6625	Articaine Hydrochloride and Epinephrine	Articaine Hydrochloride and Epinephrine