articaine hydrochloride and epinephrine bitartrate

FDA Drug Profile — Orabloc, Articaine HCl and Epinephrine

articaine hydrochloride and epinephrine bitartrate is listed in the FDA National Drug Code directory with 4 NDC codes, marketed under brand names including Orabloc, Articaine HCl and Epinephrine. Available dosage form: injection.

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 SEPTOCAINE is indicated for local, infiltrative, or conductive anesthesia in both simple and complex dental procedures in adults and pediatric patients 4 years of age or older. SEPTOCAINE 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 or older.