Bupivacaine / Epinephrine Cartridge

Brand(s)
Marcaine with Epinephrine, Vivacaine
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Hospira, Inc. (2014-02-11)
Oldest Current Product
1972-10-03
License(s)
NDA, ANDA
RxNORM
CARTRIDGE\BUPIVACAINE:EPINEPHRINE
FDAOB
INJECTION\INJECTION\BUPIVACAINE HYDROCHLORIDE: EPINEPHRINE BITARTRATE\rdfq
INJECTION\INJECTION\BUPIVACAINE HYDROCHLORIDE\rdfq
SPL Active
DENTAL\INJECTION, SOLUTION\BUPIVACAINE HYDROCHLORIDE: EPINEPHRINE BITARTRATE
SUBCUTANEOUS\INJECTION, SOLUTION\BUPIVACAINE HYDROCHLORIDE ANHYDROUS: EPINEPHRINE BITARTRATE
SUBCUTANEOUS\INJECTION, SOLUTION\BUPIVACAINE HYDROCHLORIDE: BUPIVACAINE HYDROCHLORIDE ANHYDROUS: EPINEPHRINE BITARTRATE
SPL Moiety
DENTAL\INJECTION, SOLUTION\BUPIVACAINE: EPINEPHRINE
SUBCUTANEOUS\INJECTION, SOLUTION\BUPIVACAINE: EPINEPHRINE

product(s) by strength(s)

1.8 ml bupivacaine hydrochloride 5 mg/ml / epinephrine 0.005 mg/ml cartridge

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004097600NDAHospira, Inc.1972-10-03BUPIVACAINE HYDROCHLORIDE, EPINEPHRINE BITARTRATEDENTALINJECTION, SOLUTIONNDA022046cdc3dadc-2fb8-4fac-90bd-5f858643d8c7

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003629011VivacaineANDASeptodont Inc.2009-12-17, 2013-06-01BUPIVACAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE ANHYDROUS, EPINEPHRINE BITARTRATESUBCUTANEOUSINJECTION, SOLUTIONANDA0772507257e8e4-9007-408c-9a9b-109bdd1d6d1e, b4c60d8e-e350-45b2-9d6b-5815eeb6c994
2313820557Marcaine with EpinephrineANDACarestream Health, Inc.2013-06-01BUPIVACAINE HYDROCHLORIDE ANHYDROUS, EPINEPHRINE BITARTRATESUBCUTANEOUSINJECTION, SOLUTIONANDA07725063840275-9158-466c-8a2b-f9b06a236ab2

application(s)

#idtitleapplicantapprovedapproved drugin other drug docs
1ANDA070966SENSORCAINEFRESENIUS KABI USA LLC1987-10-13ANDA070966_001Bupivacaine / Epinephrine Injectable Solution
Bupivacaine Injectable Solution
Bupivacaine / Epinephrine Injection
2ANDA070967SENSORCAINEFRESENIUS KABI USA LLC1987-10-13ANDA070967_001Bupivacaine / Epinephrine Injectable Solution
Bupivacaine Injectable Solution
Bupivacaine / Epinephrine Injection
3ANDA070968SENSORCAINEFRESENIUS KABI USA LLC1987-10-13ANDA070968_001Bupivacaine / Epinephrine Injectable Solution
Bupivacaine Injectable Solution
Bupivacaine / Epinephrine Injection
4ANDA077250BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINESEPTODONT INC2006-09-27ANDA077250_001Bupivacaine / Epinephrine Injectable Solution
Bupivacaine Injectable Solution
Bupivacaine / Epinephrine Injection
5NDA016964MARCAINE HYDROCHLORIDEHOSPIRA INCNDA016964_001, NDA016964_004, NDA016964_005, NDA016964_006, NDA016964_007, NDA016964_008, NDA016964_009, NDA016964_010, NDA016964_012, NDA016964_013Bupivacaine / Epinephrine Injectable Solution
Bupivacaine Injectable Solution
Bupivacaine / Epinephrine Injection
Bupivacaine Prefilled Syringe
6NDA018304SENSORCAINEFRESENIUS KABI USA LLCNDA018304_001, NDA018304_002, NDA018304_003, NDA018304_004, NDA018304_005Bupivacaine / Epinephrine Injectable Solution
Bupivacaine Injectable Solution
Bupivacaine / Epinephrine Injection
Bupivacaine Prefilled Syringe
7NDA022046BUPIVACAINE HYDROCHLORIDE W/EPINEPHRINEHOSPIRA INC1983-07-13NDA022046_001Bupivacaine / Epinephrine Injectable Solution
Bupivacaine Injectable Solution
Bupivacaine / Epinephrine Injection

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1ANDA070966_001RXBUPIVACAINE HYDROCHLORIDE (0.25%), EPINEPHRINE BITARTRATE (0.0091MG/ML)INJECTIONFalseAP1987-10-13SENSORCAINE
2ANDA070967_001RXBUPIVACAINE HYDROCHLORIDE (0.25%), EPINEPHRINE BITARTRATE (0.0091MG/ML)INJECTIONFalseAP1987-10-13SENSORCAINE
3ANDA070968_001RXEPINEPHRINE BITARTRATE (0.0091MG/ML), BUPIVACAINE HYDROCHLORIDE (0.5%)INJECTIONFalseAP1987-10-13SENSORCAINE
4ANDA077250_001RXBUPIVACAINE HYDROCHLORIDE (0.5%), EPINEPHRINE BITARTRATE (0.0091MG/ML)INJECTIONFalseAP2006-09-27BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE
5NDA016964_001RXBUPIVACAINE HYDROCHLORIDE (0.25%)INJECTIONTrueAPMARCAINE HYDROCHLORIDE
6NDA016964_004RXEPINEPHRINE BITARTRATE (0.0091MG/ML), BUPIVACAINE HYDROCHLORIDE (0.25%)INJECTIONTrueAPMARCAINE HYDROCHLORIDE
7NDA016964_005RXBUPIVACAINE HYDROCHLORIDE (0.5%)INJECTIONTrueAPMARCAINE HYDROCHLORIDE
8NDA016964_006RXBUPIVACAINE HYDROCHLORIDE (0.5%)INJECTIONTrueAPMARCAINE HYDROCHLORIDE
9NDA016964_007RXEPINEPHRINE BITARTRATE (0.0091MG/ML), BUPIVACAINE HYDROCHLORIDE (0.5%)INJECTIONTrueAPMARCAINE HYDROCHLORIDE
10NDA016964_008RXEPINEPHRINE BITARTRATE (0.0091MG/ML), BUPIVACAINE HYDROCHLORIDE (0.5%)INJECTIONTrueAPMARCAINE HYDROCHLORIDE
11NDA016964_009RXBUPIVACAINE HYDROCHLORIDE (0.75%)INJECTIONTrueAPMARCAINE HYDROCHLORIDE
12NDA016964_010RXEPINEPHRINE BITARTRATE (0.0091MG/ML), BUPIVACAINE HYDROCHLORIDE (0.75%)INJECTIONTrueAPMARCAINE HYDROCHLORIDE
13NDA016964_012RXBUPIVACAINE HYDROCHLORIDE (0.25%)INJECTIONTrueAPMARCAINE HYDROCHLORIDE
14NDA016964_013RXBUPIVACAINE HYDROCHLORIDE (0.25%), EPINEPHRINE BITARTRATE (0.0091MG/ML)INJECTIONTrueAPMARCAINE HYDROCHLORIDE
15NDA018304_001RXBUPIVACAINE HYDROCHLORIDE (0.25%)INJECTIONFalseAPSENSORCAINE
16NDA018304_002RXBUPIVACAINE HYDROCHLORIDE (0.5%)INJECTIONFalseAPSENSORCAINE
17NDA018304_003RXBUPIVACAINE HYDROCHLORIDE (0.75%)INJECTIONFalseAPSENSORCAINE
18NDA018304_004RXBUPIVACAINE HYDROCHLORIDE (0.5%), EPINEPHRINE BITARTRATE (0.0091MG/ML)INJECTIONFalseAP1983-09-02SENSORCAINE
19NDA018304_005RXBUPIVACAINE HYDROCHLORIDE (0.75%), EPINEPHRINE BITARTRATE (0.0091MG/ML)INJECTIONFalseAP1983-09-02SENSORCAINE
20NDA022046_001RXBUPIVACAINE HYDROCHLORIDE (0.5%), EPINEPHRINE BITARTRATE (0.0091MG/ML)INJECTIONTrueAP1983-07-13BUPIVACAINE HYDROCHLORIDE W/EPINEPHRINE

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
163840275-9158-466c-8a2b-f9b06a236ab2 (view SPL)Marcaine 0.5% with epinephrine 1:200,000 injection (as bitartrate)(bupivacaine hydrochloride and epinephrine injection, USP)prescriptionHuman PrescriptionCarestream Health, Inc.MANUFACTURE2013-06-012313820557
27257e8e4-9007-408c-9a9b-109bdd1d6d1e (view SPL)Vivacaine Bupivacaine HCl 0.5% and Epinephrine 1:200,000 Injection (as bitartrate) (Bupivacaine Hydrochloride and Epinephrine Injection, USP)prescriptionHuman PrescriptionSeptodont Inc.MANUFACTURE2010-06-291003629011
3b4c60d8e-e350-45b2-9d6b-5815eeb6c994 (view SPL)Vivacaine Bupivacaine HCl 0.5% and Epinephrine 1:200,000 Injection (as bitartrate) (Bupivacaine Hydrochloride and Epinephrine Injection, USP)prescriptionHuman PrescriptionSeptodont Inc.MANUFACTURE2015-09-083003629011
4cdc3dadc-2fb8-4fac-90bd-5f858643d8c7 (view SPL)Bupivacaine HCl 0.5% with epinephrine 1:200,000 (as bitartrate)prescriptionHuman PrescriptionHospira, Inc.2014-02-1113004097600

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