FDA.reportPublic FDA data

Articaine Hydrochloride and Epinephrine

Product NDC
51004-6625
11-digit product format
510046625
Labeler code
51004
Product ID
51004-6625_790f8c36-8777-46b2-a3aa-eaa505695d78
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Articaine Hydrochloride and Epinephrine
Dosage form
INJECTION, SOLUTION
Route
SUBMUCOSAL
Labeler
Novocol Pharmaceutical of Canada, Inc.
Application
NDA020971
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2014-01-28
Substance
ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE
Active strength
40; .005 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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Articaine Hydrochloride and Epinephrine
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ARTICAINE HYDROCHLORIDE40 mg/mL
EPINEPHRINE BITARTRATE.005 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiQS9014Q792, 30Q7KI53AK
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51004-6625-5Articaine Hydrochloride and Epinephrine50 in 1 CARTONINJECTION, SOLUTION501
51004-6625-5Articaine Hydrochloride and Epinephrine1.7 mL in 1 CARTRIDGEINJECTION, SOLUTION1.71

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1595035articaine HCl 4 % / EPINEPHrine 1:100,000 in 1.7 mL Dental CartridgePSN636cbf11-819c-48f8-915d-ac5fb38bd3521
1595029articaine HCl 4 % / EPINEPHrine 1:200,000 in 1.7 mL Dental CartridgePSN636cbf11-819c-48f8-915d-ac5fb38bd3521
15950291.7 ML articaine hydrochloride 40 MG/ML / epinephrine 0.005 MG/ML CartridgeSCD636cbf11-819c-48f8-915d-ac5fb38bd3521
15950351.7 ML articaine hydrochloride 40 MG/ML / epinephrine 0.01 MG/ML CartridgeSCD636cbf11-819c-48f8-915d-ac5fb38bd3521
1595035articaine HCl 4 % / epinephrine 1:100,000 (as epinephrine bitartrate 0.018 MG/ML) 1.7ML Dental CartridgeSY636cbf11-819c-48f8-915d-ac5fb38bd3521
1595035articaine HCl 4 % / epinephrine 1:100,000 1.7 ML Dental CartridgeSY636cbf11-819c-48f8-915d-ac5fb38bd3521
1595029articaine HCl 4 % / epinephrine 1:200,000 1.7 ML CartridgeSY636cbf11-819c-48f8-915d-ac5fb38bd3521

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51004-6625-55100466250550 CARTRIDGE in 1 CARTON (51004-6625-5) / 1.7 mL in 1 CARTRIDGE50 cartridge2014-01-28NoNoHistorical