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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code45146-120
Application NumberNDA022466
Product Classification
M
Marketing Category
C73594
G
Generic Name
articaine hydrochloride and epinephrine bitartrate
Product Specifications
Route of AdministrationSUBMUCOSAL
Effective DateJuly 23, 2016
FDA Product Classification
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code45146-110
Application NumberNDA022466
Product Classification
M
Marketing Category
C73594
G
Generic Name
articaine hydrochloride and epinephrine bitartrate
Product Specifications
Route of AdministrationSUBMUCOSAL
Effective DateJuly 23, 2016
FDA Product Classification
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