FDA.reportPublic FDA data

Articaine Hydrochloride and Epinephrine

Product NDC
0404-6620
11-digit product format
004046620
Labeler code
0404
Product ID
0404-6620_67eba8ba-c8c4-43f5-a482-88e4c0c355a8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Articaine Hydrochloride and Epinephrine
Dosage form
INJECTION, SOLUTION
Route
SUBMUCOSAL
Labeler
Henry Schein
Application
NDA020971
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2015-01-28
Substance
ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE
Active strength
40; .01 mg/mL; mg/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 BITARTRATE.01 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii30Q7KI53AK, QS9014Q792
Rxcui1595029, 1595035

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0404-6620-302021-11-02C16284748780-19d75b9cf-ecc0-f424-e053-dadaa90a57cedac9a21a-3ec2-45a6-856e-2aaa15ada182
0404-6620-302020-01-31C16284748780-19d75b9cf-ecc0-f424-e053-dadaa90a57cedac9a21a-3ec2-45a6-856e-2aaa15ada182

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0404-6620-05Articaine Hydrochloride and Epinephrine50 in 1 CARTONINJECTION, SOLUTION5011
0404-6620-05Articaine Hydrochloride and Epinephrine1.7 mL in 1 CARTRIDGEINJECTION, SOLUTION1.711

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Articaine HydrochlorideACTIVE INGREDIENTQS9014Q792ARTICAINE HYDROCHLORIDE AND EPINEPHRINE INJECTION, SOLUTION [HENRY SCHEIN]3
Epinephrine BitartrateACTIVE INGREDIENT30Q7KI53AKARTICAINE HYDROCHLORIDE AND EPINEPHRINE INJECTION, SOLUTION [HENRY SCHEIN]3
ArticaineACTIVE MOIETYD3SQ406G9XARTICAINE HYDROCHLORIDE AND EPINEPHRINE INJECTION, SOLUTION [HENRY SCHEIN]3
EpinephrineACTIVE MOIETYYKH834O4BHARTICAINE HYDROCHLORIDE AND EPINEPHRINE INJECTION, SOLUTION [HENRY SCHEIN]3
Sodium chlorideINACTIVE INGREDIENT451W47IQ8XARTICAINE HYDROCHLORIDE AND EPINEPHRINE INJECTION, SOLUTION [HENRY SCHEIN]3
Sodium HydroxideINACTIVE INGREDIENT55X04QC32IARTICAINE HYDROCHLORIDE AND EPINEPHRINE INJECTION, SOLUTION [HENRY SCHEIN]3
Sodium metabisulfiteINACTIVE INGREDIENT4VON5FNS3CARTICAINE HYDROCHLORIDE AND EPINEPHRINE INJECTION, SOLUTION [HENRY SCHEIN]3
WaterINACTIVE INGREDIENT059QF0KO0RARTICAINE HYDROCHLORIDE AND EPINEPHRINE INJECTION, SOLUTION [HENRY SCHEIN]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0404-6620ARTICAINE HYDROCHLORIDE AND EPINEPHRINE INJECTION, SOLUTION [HENRY SCHEIN]11Current NDC, Legacy NDC, 2 package rows20240302_d9402ac2-fedd-4fb0-90a3-2c466a786526.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1595035articaine HCl 4 % / EPINEPHrine 1:100,000 in 1.7 mL Dental CartridgePSNd9402ac2-fedd-4fb0-90a3-2c466a78652611
1595029articaine HCl 4 % / EPINEPHrine 1:200,000 in 1.7 mL Dental CartridgePSNd9402ac2-fedd-4fb0-90a3-2c466a78652611
15950291.7 ML articaine hydrochloride 40 MG/ML / epinephrine 0.005 MG/ML CartridgeSCDd9402ac2-fedd-4fb0-90a3-2c466a78652611
15950351.7 ML articaine hydrochloride 40 MG/ML / epinephrine 0.01 MG/ML CartridgeSCDd9402ac2-fedd-4fb0-90a3-2c466a78652611
1595035articaine HCl 4 % / epinephrine 1:100,000 (as epinephrine bitartrate 0.018 MG/ML) 1.7ML Dental CartridgeSYd9402ac2-fedd-4fb0-90a3-2c466a78652611
1595035articaine HCl 4 % / epinephrine 1:100,000 1.7 ML Dental CartridgeSYd9402ac2-fedd-4fb0-90a3-2c466a78652611
1595029articaine HCl 4 % / epinephrine 1:200,000 1.7 ML CartridgeSYd9402ac2-fedd-4fb0-90a3-2c466a78652611

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0404-6620-050040466200550 CARTRIDGE in 1 CARTON (0404-6620-05) / 1.7 mL in 1 CARTRIDGE50 cartridge2015-01-280000-00-00NoNoCurrent