Orabloc
ORABLOC® (articaine HCl and epinephrine) injection, for intraoral submucosal infiltration use Initial U.S. Approval: 2000
Approved
Approval ID
d18424f0-a691-11dd-ad8b-0800200c9a66
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 22, 2018
Manufacturers
FDA
Pierrel S.p.A.
DUNS: 458463044
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
articaine hydrochloride and epinephrine bitartrate
PRODUCT DETAILS
NDC Product Code45146-120
Application NumberNDA022466
Marketing CategoryC73594
Route of AdministrationSUBMUCOSAL
Effective DateJuly 23, 2016
Generic Namearticaine hydrochloride and epinephrine bitartrate
INGREDIENTS (2)
ARTICAINE HYDROCHLORIDEActive
Quantity: 40 mg in 1 mL
Code: QS9014Q792
Classification: ACTIB
EPINEPHRINE BITARTRATEActive
Quantity: 5 ug in 1 mL
Code: 30Q7KI53AK
Classification: ACTIM
articaine hydrochloride and epinephrine bitartrate
PRODUCT DETAILS
NDC Product Code45146-110
Application NumberNDA022466
Marketing CategoryC73594
Route of AdministrationSUBMUCOSAL
Effective DateJuly 23, 2016
Generic Namearticaine hydrochloride and epinephrine bitartrate
INGREDIENTS (2)
ARTICAINE HYDROCHLORIDEActive
Quantity: 40 mg in 1 mL
Code: QS9014Q792
Classification: ACTIB
EPINEPHRINE BITARTRATEActive
Quantity: 10 ug in 1 mL
Code: 30Q7KI53AK
Classification: ACTIM