FDA.reportPublic FDA data

Septocaine and Epinephrine

Product NDC
0362-9049
11-digit product format
003629049
Labeler code
0362
Product ID
0362-9049_85af79f0-c765-4758-8ae8-e68ebdb70dd8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Articaine Hydrochloride and Epinephrine Bitartrate
Dosage form
INJECTION, SOLUTION
Route
SUBMUCOSAL
Labeler
Septodont Inc.
Application
NDA020971
Marketing category
NDA
Marketing start
2011-01-12
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
Septocaine 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
UniiQS9014Q792, 30Q7KI53AK
Rxcui861588, 1150829, 1595029, 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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
f7046b89-2016-499a-adc6-78479172abc6Product name120230425
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
2686d634-e712-4007-8dbf-3d37c6c4d71fProduct name120181121
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
bd49bb86-2d32-4a7a-a594-eeda2e29af42Product name120180118
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
3becbe78-12d9-4ad2-9b4c-1e36f8d1303aProduct name120170815
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0362-9049-052020-01-31C16284748780-19d75b9d0-64c3-f424-e053-dadaa90a57cef08c9f36-47d8-418a-aeef-d3f1d83e805c

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0362-9049-02Septocaine and Epinephrine1.7 mL in 1 CARTRIDGEINJECTION, SOLUTION1.714
0362-9049-02Septocaine and Epinephrine50 in 1 CARTONINJECTION, SOLUTION5014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0362-9049-02ML - Milliliter0362-9049b25e2a2d-192f-4676-a128-2a28a9ad7a8512019-11-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Articaine HydrochlorideACTIVE INGREDIENTQS9014Q792SEPTOCAINE AND EPINEPHRINE (ARTICAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [SEPTODONT INC.]4
Epinephrine BitartrateACTIVE INGREDIENT30Q7KI53AKSEPTOCAINE AND EPINEPHRINE (ARTICAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [SEPTODONT INC.]4
ArticaineACTIVE MOIETYD3SQ406G9XSEPTOCAINE AND EPINEPHRINE (ARTICAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [SEPTODONT INC.]4
EpinephrineACTIVE MOIETYYKH834O4BHSEPTOCAINE AND EPINEPHRINE (ARTICAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [SEPTODONT INC.]4
Sodium chlorideINACTIVE INGREDIENT451W47IQ8XSEPTOCAINE AND EPINEPHRINE (ARTICAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [SEPTODONT INC.]4
Sodium hydroxideINACTIVE INGREDIENT55X04QC32ISEPTOCAINE AND EPINEPHRINE (ARTICAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [SEPTODONT INC.]4
Sodium metabisulfiteINACTIVE INGREDIENT4VON5FNS3CSEPTOCAINE AND EPINEPHRINE (ARTICAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [SEPTODONT INC.]4
WaterINACTIVE INGREDIENT059QF0KO0RSEPTOCAINE AND EPINEPHRINE (ARTICAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [SEPTODONT INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0362-9049SEPTOCAINE AND EPINEPHRINE (ARTICAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [SEPTODONT INC.]14Current NDC, Legacy NDC, 2 package rows20241025_0eba0bd2-ccb6-4f7e-8d0c-e4b4e6cdce03.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1595035articaine HCl 4 % / EPINEPHrine 1:100,000 in 1.7 mL Dental CartridgePSN0eba0bd2-ccb6-4f7e-8d0c-e4b4e6cdce0314
1595029articaine HCl 4 % / EPINEPHrine 1:200,000 in 1.7 mL Dental CartridgePSN0eba0bd2-ccb6-4f7e-8d0c-e4b4e6cdce0314
861588Septocaine 4 % / 1:100,000 in 1.7 mL Dental CartridgePSN0eba0bd2-ccb6-4f7e-8d0c-e4b4e6cdce0314
1150829Septocaine 4 % / 1:200,000 in 1.7 mL Dental CartridgePSN0eba0bd2-ccb6-4f7e-8d0c-e4b4e6cdce0314
11508291.7 ML articaine hydrochloride 40 MG/ML / epinephrine 0.005 MG/ML Cartridge [Septocaine]SBD0eba0bd2-ccb6-4f7e-8d0c-e4b4e6cdce0314
8615881.7 ML articaine hydrochloride 40 MG/ML / epinephrine 0.01 MG/ML Cartridge [Septocaine]SBD0eba0bd2-ccb6-4f7e-8d0c-e4b4e6cdce0314
15950291.7 ML articaine hydrochloride 40 MG/ML / epinephrine 0.005 MG/ML CartridgeSCD0eba0bd2-ccb6-4f7e-8d0c-e4b4e6cdce0314
15950351.7 ML articaine hydrochloride 40 MG/ML / epinephrine 0.01 MG/ML CartridgeSCD0eba0bd2-ccb6-4f7e-8d0c-e4b4e6cdce0314
1595035articaine HCl 4 % / epinephrine 1:100,000 (as epinephrine bitartrate 0.018 MG/ML) 1.7ML Dental CartridgeSY0eba0bd2-ccb6-4f7e-8d0c-e4b4e6cdce0314
1595035articaine HCl 4 % / epinephrine 1:100,000 1.7 ML Dental CartridgeSY0eba0bd2-ccb6-4f7e-8d0c-e4b4e6cdce0314
1595029articaine HCl 4 % / epinephrine 1:200,000 1.7 ML CartridgeSY0eba0bd2-ccb6-4f7e-8d0c-e4b4e6cdce0314
861588Septocaine 4 % / 1:100,000 (articaine HCl / epinephrine (as epinephrine bitartrate)) 1.7 ML CartridgeSY0eba0bd2-ccb6-4f7e-8d0c-e4b4e6cdce0314
861588Septocaine 4 % / 1:100,000 in 1.7 mL Dental CartridgeSY0eba0bd2-ccb6-4f7e-8d0c-e4b4e6cdce0314
1150829Septocaine 4 % / 1:200,000 (articaine HCl / epinephrine (as epinephrine bitartrate)) 1.7 ML CartridgeSY0eba0bd2-ccb6-4f7e-8d0c-e4b4e6cdce0314
1150829Septocaine 4 % with epinephrine 1:200,000 1.7 ML CartridgeSY0eba0bd2-ccb6-4f7e-8d0c-e4b4e6cdce0314

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0362-9049-020036290490250 CARTRIDGE in 1 CARTON (0362-9049-02) / 1.7 mL in 1 CARTRIDGE50 cartridge2011-01-120000-00-00NoNoCurrent