FDA.reportPublic FDA data

Articaine Hydrochloride and Epinephrine

Product NDC
43498-816
11-digit product format
434980816
Labeler code
43498
Product ID
43498-816_644fa9c3-1491-42e3-9194-9c562617fd06
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ARTICAINE HYDROCHLORIDE, EPINEPHRINE BITARTRATE
Dosage form
INJECTION, SOLUTION
Route
SUBMUCOSAL
Labeler
Burkhart Dental Supply Co., Inc
Application
NDA022466
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2024-11-04
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 Hydrochloride 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
Unii30Q7KI53AK, QS9014Q792
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
43498-816-01Articaine Hydrochloride and Epinephrine50 in 1 BOXINJECTION, SOLUTION504
43498-816-01Articaine Hydrochloride and Epinephrine1.8 mL in 1 CARTRIDGEINJECTION, SOLUTION1.84

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43498-816ARTICAINE HYDROCHLORIDE AND EPINEPHRINE (ARTICAINE HYDROCHLORIDE, EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [BURKHART DENTAL SUPPLY CO., INC]4Current NDC, 2 package rows20241120_4f11bb06-c71b-4d96-9baa-2a17ad473a05.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1661483articaine HCl 4 % / EPINEPHrine 1:100,000 in 1.8 mL Dental CartridgePSN4f11bb06-c71b-4d96-9baa-2a17ad473a054
1658966articaine HCl 4 % / EPINEPHrine 1:200,000 in 1.8 mL Dental CartridgePSN4f11bb06-c71b-4d96-9baa-2a17ad473a054
16589661.8 ML articaine hydrochloride 40 MG/ML / epinephrine 0.005 MG/ML CartridgeSCD4f11bb06-c71b-4d96-9baa-2a17ad473a054
16614831.8 ML articaine hydrochloride 40 MG/ML / epinephrine 0.01 MG/ML CartridgeSCD4f11bb06-c71b-4d96-9baa-2a17ad473a054
1661483articaine HCl 4 % / epinephrine 1:100,000 in 1.8 mL Dental CartridgeSY4f11bb06-c71b-4d96-9baa-2a17ad473a054
1658966articaine HCl 4 % / epinephrine 1:200,000 1.8 ML CartridgeSY4f11bb06-c71b-4d96-9baa-2a17ad473a054

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
43498-816-014349808160150 CARTRIDGE in 1 BOX (43498-816-01) / 1.8 mL in 1 CARTRIDGE50 cartridge2024-11-04NoNoCurrent