Articaine HCl and Epinephrine
These highlights do not include all the information needed to use Articaine HCl and Epinephrine safely and effectively. See full prescribing information for Articaine HCl and Epinephrine. Articaine HCl and Epinephrine Injection, for intraoral submucosal infiltration use Initial U.S. Approval: 2000
Approved
Approval ID
0536a4de-578d-497e-a01b-0b1887344cc8
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 14, 2023
Manufacturers
FDA
Safco Dental Supply Co.
DUNS: 020417380
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 Code67239-0210
Application NumberNDA022466
Product Classification
M
Marketing Category
C73605
G
Generic Name
articaine hydrochloride and epinephrine bitartrate
Product Specifications
Route of AdministrationSUBMUCOSAL
Effective DateJanuary 18, 2023
FDA Product Classification
INGREDIENTS (2)
EPINEPHRINE BITARTRATEActive
Quantity: 5 ug in 1 mL
Code: 30Q7KI53AK
Classification: ACTIM
ARTICAINE HYDROCHLORIDEActive
Quantity: 40 mg in 1 mL
Code: QS9014Q792
Classification: ACTIB
articaine hydrochloride and epinephrine bitartrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code67239-0209
Application NumberNDA022466
Product Classification
M
Marketing Category
C73605
G
Generic Name
articaine hydrochloride and epinephrine bitartrate
Product Specifications
Route of AdministrationSUBMUCOSAL
Effective DateJanuary 18, 2023
FDA Product Classification
INGREDIENTS (2)
EPINEPHRINE BITARTRATEActive
Quantity: 10 ug in 1 mL
Code: 30Q7KI53AK
Classification: ACTIM
ARTICAINE HYDROCHLORIDEActive
Quantity: 40 mg in 1 mL
Code: QS9014Q792
Classification: ACTIB