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Articaine Hydrochloride 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 Hydrochloride 4% and Epinephrine 1:100,000 Injection Articaine Hydrochloride 4% and Epinephrine 1:200,000 Injection (articaine hydrochloride and epinephrine injection), for intraoral submucosal infiltration use Initial U.S. Approval: 2000

Approved
Approval ID

be742506-8c6e-6ff2-e053-2995a90a6b21

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 12, 2022

Manufacturers
FDA

Midway Dental Supply, LLC

DUNS: 102354446

Products 2

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

ARTICAINE HYDROCHLORIDE, EPINEPHRINE BITARTRATE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code72304-015
Application NumberNDA022466
Product Classification
M
Marketing Category
C73594
G
Generic Name
ARTICAINE HYDROCHLORIDE, EPINEPHRINE BITARTRATE
Product Specifications
Route of AdministrationSUBMUCOSAL
Effective DateDecember 12, 2022
FDA Product Classification

INGREDIENTS (5)

SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM METABISULFITEInactive
Code: 4VON5FNS3C
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ARTICAINE HYDROCHLORIDEActive
Quantity: 40 mg in 1 mL
Code: QS9014Q792
Classification: ACTIB
EPINEPHRINE BITARTRATEActive
Quantity: 10 ug in 1 mL
Code: 30Q7KI53AK
Classification: ACTIM

ARTICAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code72304-016
Application NumberNDA022466
Product Classification
M
Marketing Category
C73594
G
Generic Name
ARTICAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE
Product Specifications
Route of AdministrationSUBMUCOSAL
Effective DateDecember 12, 2022
FDA Product Classification

INGREDIENTS (5)

SODIUM METABISULFITEInactive
Code: 4VON5FNS3C
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
EPINEPHRINE BITARTRATEActive
Quantity: 5 ug in 1 mL
Code: 30Q7KI53AK
Classification: ACTIM
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ARTICAINE HYDROCHLORIDEActive
Quantity: 40 mg in 1 mL
Code: QS9014Q792
Classification: ACTIB

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