Articaine / Epinephrine Cartridge

Brand(s)
Articadent, Orabloc, Septocaine, Zorcaine
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Pierrel S.P.A. (2013-09-12)
Oldest Current Product
2000-04-03
License(s)
NDA, ANDA
RxNORM
CARTRIDGE\ARTICAINE:EPINEPHRINE
FDAOB
INJECTION\INJECTION\ARTICAINE HYDROCHLORIDE: EPINEPHRINE BITARTRATE\rdfq
SPL Active
DENTAL\INJECTION, SOLUTION\ARTICAINE HYDROCHLORIDE: EPINEPHRINE BITARTRATE
SUBCUTANEOUS\INJECTION, SOLUTION\ARTICAINE HYDROCHLORIDE: EPINEPHRINE BITARTRATE
SUBMUCOSAL\INJECTION\ARTICAINE HYDROCHLORIDE: EPINEPHRINE BITARTRATE
SPL Moiety
DENTAL\INJECTION, SOLUTION\ARTICAINE: EPINEPHRINE
SUBCUTANEOUS\INJECTION, SOLUTION\ARTICAINE: EPINEPHRINE
SUBMUCOSAL\INJECTION\ARTICAINE: EPINEPHRINE

product(s) by strength(s)

1.7 ml articaine hydrochloride 40 mg/ml / epinephrine 0.005 mg/ml cartridge

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1502271050NDAPatterson Dental2014-12-22ARTICAINE HYDROCHLORIDE, EPINEPHRINE BITARTRATESUBCUTANEOUSINJECTION, SOLUTIONNDA0209712b5a7ee3-71ee-4c41-ad9f-852f170470b3
2663120602ArticadentNDADentsply Pharmaceutical2000-04-03ARTICAINE HYDROCHLORIDE, EPINEPHRINE BITARTRATESUBCUTANEOUSINJECTION, SOLUTIONNDA0209719ca8fb43-4f34-47c0-8b79-3b5bd1eaee00

1.8 ml articaine hydrochloride 40 mg/ml / epinephrine 0.005 mg/ml cartridge

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1451460120OrablocNDAPierrel S.P.A.2011-03-01ARTICAINE HYDROCHLORIDE, EPINEPHRINE BITARTRATESUBMUCOSALINJECTIONNDA022466d18424f0-a691-11dd-ad8b-0800200c9a66

1.8 ml articaine hydrochloride 40 mg/ml / epinephrine 0.01 mg/ml cartridge

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1451460110OrablocNDAPierrel S.P.A.2011-03-01ARTICAINE HYDROCHLORIDE, EPINEPHRINE BITARTRATESUBMUCOSALINJECTIONNDA022466d18424f0-a691-11dd-ad8b-0800200c9a66

1.7 ml articaine hydrochloride 40 mg/ml / epinephrine 0.01 mg/ml cartridge

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004046620NDAHenry Schein Inc.2015-01-28ARTICAINE HYDROCHLORIDE, EPINEPHRINE BITARTRATESUBCUTANEOUSINJECTION, SOLUTIONNDA020971d9402ac2-fedd-4fb0-90a3-2c466a786526
2313820830ZorcaineNDACarestream Health, Inc.2011-09-01ARTICAINE HYDROCHLORIDE, EPINEPHRINE BITARTRATESUBCUTANEOUSINJECTION, SOLUTIONNDA020971da242926-93db-4a2b-b68c-23af13ea747e
3431280101NDANdc, Inc.2015-06-22ARTICAINE HYDROCHLORIDE, EPINEPHRINE BITARTRATESUBCUTANEOUSINJECTION, SOLUTIONNDA0209710b0cbbec-8216-434f-892e-226c89d7239c

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004099366ANDAHospira, Inc.2011-04-01ARTICAINE HYDROCHLORIDE, EPINEPHRINE BITARTRATEDENTALINJECTION, SOLUTIONANDA0791382a3dfff2-8205-4291-4ba9-6b5600a8bbb6

application(s)

#idtitleapplicantapprovedapproved drug
1ANDA079138ARTICAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATEHOSPIRA INC2010-06-18ANDA079138_001
2NDA020971SEPTOCAINEDEPROCO INC2000-04-03NDA020971_001
3NDA022010SEPTOCAINEDEPROCO INC2006-03-30NDA022010_001
4NDA022466ORABLOCPIERREL S.P.A.2010-02-26NDA022466_001, NDA022466_002

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1ANDA079138_001RXARTICAINE HYDROCHLORIDE (4%), EPINEPHRINE BITARTRATE (EQ 0.017MG BASE/1.7ML)INJECTIONFalseAP2010-06-18ARTICAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE
2NDA020971_001RXEPINEPHRINE BITARTRATE (EQ 0.017MG BASE/1.7ML), ARTICAINE HYDROCHLORIDE (4%)INJECTIONTrueAP2000-04-03SEPTOCAINE
3NDA022010_001RXEPINEPHRINE BITARTRATE (EQ 0.0085MG BASE/1.7ML), ARTICAINE HYDROCHLORIDE (4%)INJECTIONTrue2006-03-30SEPTOCAINE
4NDA022466_001RXARTICAINE HYDROCHLORIDE (4%), EPINEPHRINE BITARTRATE (EQ 0.009MG BASE/1.8ML)INJECTIONFalse2010-02-26ORABLOC
5NDA022466_002RXEPINEPHRINE BITARTRATE (EQ 0.018MG BASE/1.8ML), ARTICAINE HYDROCHLORIDE (4%)INJECTIONTrue2010-02-26ORABLOC

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
10b0cbbec-8216-434f-892e-226c89d7239c (view SPL)These highlights do not include all the information needed to use Articaine HCl and Epinephrine safely and effectively. See full prescribing information for Articaine HCl and Epinephrine. Articaine hydrochloride 4% and epinephrine 1:200,000Articaine hydrochloride 4% and epinephrine 1:100,000 (articaine HCl and epinephrine) Injection; Intraoral Submucosal Injection Initial U.S. Approval: 2000prescriptionHuman PrescriptionNdc, Inc.MANUFACTURE2015-06-111431280101
20eba0bd2-ccb6-4f7e-8d0c-e4b4e6cdce03 (view SPL)These highlights do not include all the information needed to use Septocaine safely and effectively. See full prescribing information for Septocaine. Septocaine (articaine HCl and epinephrine) Injection; Intraoral Submucosal InjectionArticaine hydrochloride 4% and epinephrine 1:200,000Articaine hydrochloride 4% and epinephrine 1:100,000 Initial U.S. Approval: 2000prescriptionHuman PrescriptionSeptodont Inc.2011-02-014003629048, 003629049
32a3dfff2-8205-4291-4ba9-6b5600a8bbb6 (view SPL)These highlights do not include all the information needed to use Articaine hydrochloride and epinephrine injection, USP safely and effectively. See full prescribing information for Articaine hydrochloride and epinephrine injection, USP. Articaine hydrochloride and epinephrine injection, USP; Intraoral Submucosal Injection Articaine hydrochloride 4% and epinephrine 1:100,000 Initial U.S. Approval: 2000prescriptionHuman PrescriptionHospira, Inc.2014-10-0214004099366
42b5a7ee3-71ee-4c41-ad9f-852f170470b3 (view SPL)These highlights do not include all the information needed to use Articaine HCl and Epinephrine safely and effectively. See full prescribing information for Articaine HCl and Epinephrine. Articaine hydrochloride 4% and epinephrine 1:200,000Articaine hydrochloride 4% and epinephrine 1:100,000 (articaine HCl and epinephrine) Injection; Intraoral Submucosal Injection Initial U.S. Approval: 2000prescriptionHuman PrescriptionPatterson DentalMANUFACTURE2014-12-221502271050
5406de6e6-40f5-44c5-a109-3be0b9d48e58 (view SPL)These highlights do not include all the information needed to use Articaine HCl and Epinephrine safely and effectively. See full prescribing information for Articaine HCl and Epinephrine. Articaine hydrochloride 4% and epinephrine 1:200,000Articaine hydrochloride 4% and epinephrine 1:100,000 (articaine HCl and epinephrine) Injection; Intraoral Submucosal Injection Initial U.S. Approval: 2000prescriptionHuman PrescriptionPatterson DentalMANUFACTURE2014-12-221502271040
69ca8fb43-4f34-47c0-8b79-3b5bd1eaee00 (view SPL)These highlights do not include all the information needed to use Articadent safely and effectively. See full prescribing information for Articadent. Articadent (articaine HCl and epinephrine) Injection; Intraoral Submucosal InjectionArticaine hydrochloride 4% and epinephrine 1:200,000Articaine hydrochloride 4% and epinephrine 1:100,000 Initial U.S. Approval: 2000prescriptionHuman PrescriptionDentsply Pharmaceutical2014-05-203663120602, 663120601
7d18424f0-a691-11dd-ad8b-0800200c9a66 (view SPL)These highlights do not include all the information needed to use ORABLOC safely and effectively. See full prescribing information for ORABLOC. Orabloc (articaine HCl and epinephrine) Injection,Intraoral Submucosal Injection Articaine hydrochloride 4% and epinephrine 1:200,000 Articaine hydrochloride 4% and epinephrine 1:100,000 Initial U.S. Approval: 2000prescriptionHuman PrescriptionPierrel S.P.A.2013-09-1216451460110, 451460120
8d9402ac2-fedd-4fb0-90a3-2c466a786526 (view SPL)These highlights do not include all the information needed to use Articaine HCl and Epinephrine safely and effectively. See full prescribing information for Articaine HCl and Epinephrine. Articaine hydrochloride 4% and epinephrine 1:200,000Articaine hydrochloride 4% and epinephrine 1:100,000 (articaine HCl and epinephrine) Injection; Intraoral Submucosal Injection Initial U.S. Approval: 2000prescriptionHuman PrescriptionHenry Schein Inc.MANUFACTURE2015-01-223004046620, 004046625
9da242926-93db-4a2b-b68c-23af13ea747e (view SPL)These highlights do not include all the information needed to use Zurcaine; safely and effectively. See full prescribing information for Zorcaine;. Zorcaine(articaine HCl and epinephrine) Injection; Intraoral Submucosal InjectionArticaine hydrochloride 4% and epinephrine 1:200,000Articaine hydrochloride 4% and epinephrine 1:100,000 Initial U.S. Approval: 2000prescriptionHuman PrescriptionCarestream Health, Inc.MANUFACTURE2011-08-091313820830

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII