NDC 45146-120

Orabloc

Articaine Hydrochloride And Epinephrine Bitartrate

Orabloc is a Submucosal Injection in the Human Prescription Drug category. It is labeled and distributed by Pierrel S.p.a.. The primary component is Articaine Hydrochloride; Epinephrine Bitartrate.

• Product ID: 45146-120_1bdd7057-5c6b-4342-80d7-55f716a2d61d
• NDC: 45146-120
• Product Type: Human Prescription Drug
• Proprietary Name: Orabloc
• Generic Name: Articaine Hydrochloride And Epinephrine Bitartrate
• Dosage Form: Injection
• Route of Administration: SUBMUCOSAL
• Marketing Start Date: 2011-03-01
• Marketing Category: NDA / NDA
• Application Number: NDA022466
• Labeler Name: Pierrel S.p.A.
• 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 45146-120-01

100 CARTRIDGE in 1 BOX (45146-120-01) > 1.8 mL in 1 CARTRIDGE

• Marketing Start Date: 2011-03-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 45146-120-02 [45146012002]

Orabloc INJECTION

• Marketing Category: NDA
• Application Number: NDA022466
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2011-03-01

NDC 45146-120-01 [45146012001]

Orabloc INJECTION

• Marketing Category: NDA
• Application Number: NDA022466
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2011-03-01

Drug Details

Active Ingredients

Ingredient	Strength
ARTICAINE HYDROCHLORIDE	40 mg/mL

OpenFDA Data

• SPL SET ID: d18424f0-a691-11dd-ad8b-0800200c9a66
• Manufacturer:
  • Pierrel S.p.A.
• UNII:
  • QS9014Q792
  • 30Q7KI53AK
• RxNorm Concept Unique ID - RxCUI:
  • 1091068
  • 1658966
  • 1661483
  • 1091072

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

NDC	Brand Name	Generic Name
45146-110	Orabloc	articaine hydrochloride and epinephrine bitartrate
45146-120	Orabloc	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
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