NDC 31382-830

Zorcaine

Articaine Hydrochloride And Epinephrine Bitartrate

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

• Product ID: 31382-830_92cc5ca7-1aaf-4912-802c-80837ddd6e3f
• NDC: 31382-830
• Product Type: Human Prescription Drug
• Proprietary Name: Zorcaine
• Generic Name: Articaine Hydrochloride And Epinephrine Bitartrate
• Dosage Form: Injection, Solution
• Route of Administration: SUBCUTANEOUS
• Marketing Start Date: 2011-09-01
• Marketing Category: NDA / NDA
• Application Number: NDA020971
• Labeler Name: Carestream Health, 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: E
• Listing Certified Through: 2018-12-31

Packaging

NDC 31382-830-50

50 CARTRIDGE in 1 CARTON (31382-830-50) > 1.7 mL in 1 CARTRIDGE

• Marketing Start Date: 2011-09-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 31382-830-50 [31382083050]

Zorcaine INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA020971
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2011-09-01
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
ARTICAINE HYDROCHLORIDE	40 mg/mL

OpenFDA Data

• SPL SET ID: da242926-93db-4a2b-b68c-23af13ea747e
• Manufacturer:
  • Carestream Health, 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 Bitartrate"

NDC	Brand Name	Generic Name
0362-0830	Zorcaine	Articaine Hydrochloride and Epinephrine
31382-830	Zorcaine	Articaine hydrochloride and Epinephrine Bitartrate
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