NDC 0362-9048

Septocaine and Epinephrine

Articaine Hydrochloride And Epinephrine Bitartrate

Septocaine and Epinephrine 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: 0362-9048_1ebdfa61-8464-4a47-bb0b-83373b3cfe24
• NDC: 0362-9048
• Product Type: Human Prescription Drug
• Proprietary Name: Septocaine and Epinephrine
• Generic Name: Articaine Hydrochloride And Epinephrine Bitartrate
• Dosage Form: Injection, Solution
• Route of Administration: SUBCUTANEOUS
• Marketing Start Date: 2011-01-12
• 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 0362-9048-02

50 CARTRIDGE in 1 CARTON (0362-9048-02) > 1.7 mL in 1 CARTRIDGE

• Marketing Start Date: 2011-01-12
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0362-9048-02 [00362904802]

Septocaine and Epinephrine INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA020971
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2011-01-12

Drug Details

Active Ingredients

Ingredient	Strength
ARTICAINE HYDROCHLORIDE	40 mg/mL

OpenFDA Data

• SPL SET ID: 0eba0bd2-ccb6-4f7e-8d0c-e4b4e6cdce03
• Manufacturer:
  • Septodont Inc.
• UNII:
  • QS9014Q792
  • 30Q7KI53AK
• RxNorm Concept Unique ID - RxCUI:
  • 861588
  • 1595035
  • 1595029
  • 1150829

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

NDC	Brand Name	Generic Name
0362-9048	Septocaine and Epinephrine	Articaine Hydrochloride and Epinephrine Bitartrate
0362-9049	Septocaine and Epinephrine	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
31382-830	Zorcaine	Articaine hydrochloride and Epinephrine Bitartrate