articaine hydrochloride and epinephrine bitartrate

FDA Drug Profile — Orabloc, Articaine HCl and Epinephrine

Drug Details

Generic Name
articaine hydrochloride and epinephrine bitartrate
Brand Names
Orabloc, Articaine HCl and Epinephrine
Application Number
NDA022466
Sponsor
Pierrel S.p.A.
NDC Codes
4
Dosage Forms
INJECTION
Routes
SUBMUCOSAL
Active Ingredients
ARTICAINE HYDROCHLORIDE, EPINEPHRINE BITARTRATE

Indications and Usage

1 INDICATIONS AND USAGE Articaine HCl and Epinephrine is indicated for local, infiltrative, or conductive anesthesia in both simple and complex dental procedures in adults and pediatric patients 4 years of age and older. Articaine HCl and Epinephrine is a combination of articaine HCl, an amide local anesthetic, and epinephrine, a vasoconstrictor, indicated for local, infiltrative, or conductive anesthesia in both simple and complex dental procedures in adults and pediatric patients 4 years of age and older ( 1 ).