FDA.reportPublic FDA data

Articaine HCl and Epinephrine

Product NDC
67239-0209
11-digit product format
672390209
Labeler code
67239
Product ID
67239-0209_253a3ea1-c583-49d4-9655-b33ffa1115b0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
articaine hydrochloride and epinephrine bitartrate
Dosage form
INJECTION
Route
SUBMUCOSAL
Labeler
Safco Dental Supply Co.
Application
NDA022466
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2016-06-01
Substance
ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE
Active strength
40; 10 mg/mL; ug/mL
Pharmacologic classes
Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Amide Local Anesthetic [EPC], Amides [CS], Catecholamine [EPC], Catecholamines [CS], Local Anesthesia [PE], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Articaine HCl and Epinephrine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ARTICAINE HYDROCHLORIDE40 mg/mL
EPINEPHRINE BITARTRATE10 ug/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiQS9014Q792, 30Q7KI53AK
Rxcui1658966, 1661483

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0b4ec9ca-d305-43fc-88dd-7a510313efe0Product name120260105
bb209f42-a85f-4fee-9d3d-c9dded168625Product name120251208
49628fc7-2031-4c28-bd31-0ef3aa8f44a3Product name320251118
cbf85893-59ef-423f-87d4-a573c000a8b9Product name820250731
b5b1095b-40cd-8a9e-b111-502545045b07Product name420250325
e190029e-423b-473c-8e04-2ada59b5b711Product name120250314
e0031c74-3853-42bc-8e10-86dbbe83992eProduct name220231116
f7046b89-2016-499a-adc6-78479172abc6Product name120230425
2686d634-e712-4007-8dbf-3d37c6c4d71fProduct name120181121
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
bd49bb86-2d32-4a7a-a594-eeda2e29af42Product name120180118
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
3becbe78-12d9-4ad2-9b4c-1e36f8d1303aProduct name120170815

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67239-0209-1Articaine HCl and Epinephrine50 in 1 CARTONINJECTION507
67239-0209-1Articaine HCl and Epinephrine1.8 mL in 1 CARTRIDGEINJECTION1.87

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67239-0209ARTICAINE HCL AND EPINEPHRINE (ARTICAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION [SAFCO DENTAL SUPPLY CO.]7Current NDC, Legacy NDC, 2 package rows20230220_0536a4de-578d-497e-a01b-0b1887344cc8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1661483articaine HCl 4 % / EPINEPHrine 1:100,000 in 1.8 mL Dental CartridgePSN0536a4de-578d-497e-a01b-0b1887344cc87
1658966articaine HCl 4 % / EPINEPHrine 1:200,000 in 1.8 mL Dental CartridgePSN0536a4de-578d-497e-a01b-0b1887344cc87
16589661.8 ML articaine hydrochloride 40 MG/ML / epinephrine 0.005 MG/ML CartridgeSCD0536a4de-578d-497e-a01b-0b1887344cc87
16614831.8 ML articaine hydrochloride 40 MG/ML / epinephrine 0.01 MG/ML CartridgeSCD0536a4de-578d-497e-a01b-0b1887344cc87
1661483articaine HCl 4 % / epinephrine 1:100,000 in 1.8 mL Dental CartridgeSY0536a4de-578d-497e-a01b-0b1887344cc87
1658966articaine HCl 4 % / epinephrine 1:200,000 1.8 ML CartridgeSY0536a4de-578d-497e-a01b-0b1887344cc87

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67239-0209-16723902090150 CARTRIDGE in 1 CARTON (67239-0209-1) / 1.8 mL in 1 CARTRIDGE50 cartridge2016-06-010000-00-00NoNoCurrent