Bupivacaine / Epinephrine Injection

Brand(s)
Marcaine with Epinephrine, Sensorcaine with Epinephrine
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
App Pharmaceuticals, Llc (2014-11-03)
Oldest Current Product
1988-06-16
License(s)
NDA, ANDA
RxNORM
INJECTION\BUPIVACAINE:EPINEPHRINE
FDAOB
INJECTION\INJECTION\BUPIVACAINE HYDROCHLORIDE: EPINEPHRINE BITARTRATE\rdfq
INJECTION\INJECTION\BUPIVACAINE HYDROCHLORIDE: EPINEPHRINE\rdfq
INJECTION\INJECTION\BUPIVACAINE HYDROCHLORIDE\rdfq
SPL Active
EPIDURAL\INJECTION, SOLUTION\BUPIVACAINE HYDROCHLORIDE: EPINEPHRINE BITARTRATE
PERINEURAL\INJECTION, SOLUTION\BUPIVACAINE HYDROCHLORIDE: EPINEPHRINE BITARTRATE
SPL Moiety
EPIDURAL\INJECTION, SOLUTION\BUPIVACAINE: EPINEPHRINE
PERINEURAL\INJECTION, SOLUTION\BUPIVACAINE: EPINEPHRINE

product(s) by strength(s)

bupivacaine hydrochloride 5 mg/ml / epinephrine 0.005 mg/ml injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1633230462Sensorcaine with EpinephrineNDAApp Pharmaceuticals, Llc2010-11-19BUPIVACAINE HYDROCHLORIDE, EPINEPHRINE BITARTRATEPERINEURALINJECTION, SOLUTIONNDA018304eb6d8fee-def4-4c96-9972-695e8cea8ea8

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004099045ANDAHospira, Inc.1988-06-16BUPIVACAINE HYDROCHLORIDE, EPINEPHRINE BITARTRATEEPIDURALINJECTION, SOLUTIONANDA07116802a845c3-4521-4926-e397-25ab536e7cf6

application(s)

#idtitledeprecatedapplicantapprovedapproved drugin other drug docs
1ANDA070552SENSORCAINEFRESENIUS KABI USA LLC1986-05-21ANDA070552_001Bupivacaine / Epinephrine Injectable Solution
Bupivacaine Injectable Solution
Bupivacaine Prefilled Syringe
2ANDA070553SENSORCAINEFRESENIUS KABI USA LLC1986-05-21ANDA070553_001Bupivacaine / Epinephrine Injectable Solution
Bupivacaine Injectable Solution
Bupivacaine Prefilled Syringe
3ANDA070554SENSORCAINEFRESENIUS KABI USA LLC1986-05-21ANDA070554_001Bupivacaine / Epinephrine Injectable Solution
Bupivacaine Injectable Solution
Bupivacaine Prefilled Syringe
4ANDA070583BUPIVACAINE HYDROCHLORIDEHOSPIRA INC1987-02-17ANDA070583_001Bupivacaine / Epinephrine Injectable Solution
Bupivacaine Injectable Solution
Bupivacaine Prefilled Syringe
5ANDA070584BUPIVACAINE HYDROCHLORIDEHOSPIRA INC1986-02-17ANDA070584_001Bupivacaine / Epinephrine Injectable Solution
Bupivacaine Injectable Solution
Bupivacaine Prefilled Syringe
6ANDA070585BUPIVACAINE HYDROCHLORIDEHOSPIRA INC1987-03-03ANDA070585_001Bupivacaine / Epinephrine Injectable Solution
Bupivacaine Injectable Solution
Bupivacaine Prefilled Syringe
7ANDA070586BUPIVACAINE HYDROCHLORIDEHOSPIRA INC1987-03-03ANDA070586_001Bupivacaine / Epinephrine Injectable Solution
Bupivacaine Injectable Solution
Bupivacaine Prefilled Syringe
8ANDA070587BUPIVACAINE HYDROCHLORIDETrueHOSPIRA INC1987-03-03ANDA070587_001Bupivacaine / Epinephrine Injectable Solution
Bupivacaine Injectable Solution
Bupivacaine Prefilled Syringe
9ANDA070590BUPIVACAINE HYDROCHLORIDEHOSPIRA INC1987-02-17ANDA070590_001Bupivacaine / Epinephrine Injectable Solution
Bupivacaine Injectable Solution
Bupivacaine Prefilled Syringe
10ANDA070597BUPIVACAINE HYDROCHLORIDEHOSPIRA INC1987-03-03ANDA070597_001Bupivacaine / Epinephrine Injectable Solution
Bupivacaine Injectable Solution
Bupivacaine Prefilled Syringe
11ANDA070609BUPIVACAINE HYDROCHLORIDEHOSPIRA INC1987-03-03ANDA070609_001Bupivacaine / Epinephrine Injectable Solution
Bupivacaine Injectable Solution
Bupivacaine Prefilled Syringe
12ANDA070966SENSORCAINEFRESENIUS KABI USA LLC1987-10-13ANDA070966_001Bupivacaine / Epinephrine Injectable Solution
Bupivacaine Injectable Solution
Bupivacaine / Epinephrine Cartridge
13ANDA070967SENSORCAINEFRESENIUS KABI USA LLC1987-10-13ANDA070967_001Bupivacaine / Epinephrine Injectable Solution
Bupivacaine Injectable Solution
Bupivacaine / Epinephrine Cartridge
14ANDA070968SENSORCAINEFRESENIUS KABI USA LLC1987-10-13ANDA070968_001Bupivacaine / Epinephrine Injectable Solution
Bupivacaine Injectable Solution
Bupivacaine / Epinephrine Cartridge
15ANDA071165BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINEHOSPIRA INC1988-06-16ANDA071165_001Bupivacaine / Epinephrine Injectable Solution
16ANDA071166BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINETrueHOSPIRA INC1988-06-16ANDA071166_001Bupivacaine / Epinephrine Injectable Solution
17ANDA071167BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINEHOSPIRA INC1988-06-16ANDA071167_001Bupivacaine / Epinephrine Injectable Solution
18ANDA071168BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINEHOSPIRA INC1988-06-16ANDA071168_001Bupivacaine / Epinephrine Injectable Solution
19ANDA071169BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINETrueHOSPIRA INC1988-06-16ANDA071169_001Bupivacaine / Epinephrine Injectable Solution
20ANDA071170BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINEHOSPIRA INC1988-06-16ANDA071170_001Bupivacaine / Epinephrine Injectable Solution
21ANDA071171BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINETrueHOSPIRA INC1988-06-16ANDA071171_001Bupivacaine / Epinephrine Injectable Solution
22ANDA076012BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREETrueINTERNATIONAL MEDICATED SYSTEMS LTD2002-01-09ANDA076012_001, ANDA076012_002, ANDA076012_003Bupivacaine / Epinephrine Injectable Solution
Bupivacaine Injectable Solution
Bupivacaine Prefilled Syringe
23ANDA077250BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINESEPTODONT INC2006-09-27ANDA077250_001Bupivacaine / Epinephrine Injectable Solution
Bupivacaine Injectable Solution
Bupivacaine / Epinephrine Cartridge
24ANDA091487BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREESAGENT AGILA LLC2011-10-18ANDA091487_001, ANDA091487_002, ANDA091487_003Bupivacaine / Epinephrine Injectable Solution
Bupivacaine Injectable Solution
Bupivacaine Prefilled Syringe
25ANDA091503BUPIVACAINE HYDROCHLORIDESAGENT AGILA LLC2011-10-18ANDA091503_001, ANDA091503_002Bupivacaine / Epinephrine Injectable Solution
Bupivacaine Injectable Solution
Bupivacaine Prefilled Syringe
26ANDA203895BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREEAUROBINDO PHARMA LTD2013-11-05ANDA203895_001, ANDA203895_002, ANDA203895_003Bupivacaine / Epinephrine Injectable Solution
Bupivacaine Injectable Solution
Bupivacaine Prefilled Syringe
27NDA016964MARCAINE 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 Cartridge
Bupivacaine Prefilled Syringe
28NDA018053BUPIVACAINE HYDROCHLORIDEHOSPIRA INCNDA018053_001, NDA018053_002, NDA018053_003Bupivacaine / Epinephrine Injectable Solution
Bupivacaine Injectable Solution
Bupivacaine Prefilled Syringe
29NDA018304SENSORCAINEFRESENIUS KABI USA LLCNDA018304_001, NDA018304_002, NDA018304_003, NDA018304_004, NDA018304_005Bupivacaine / Epinephrine Injectable Solution
Bupivacaine Injectable Solution
Bupivacaine / Epinephrine Cartridge
Bupivacaine Prefilled Syringe
30NDA019978BUPIVACAINE HYDROCHLORIDE KITTrueHOSPIRA INC1992-09-03NDA019978_001, NDA019978_002, NDA019978_003Bupivacaine / Epinephrine Injectable Solution
Bupivacaine Injectable Solution
Bupivacaine Prefilled Syringe
31NDA022046BUPIVACAINE HYDROCHLORIDE W/EPINEPHRINEHOSPIRA INC1983-07-13NDA022046_001Bupivacaine / Epinephrine Injectable Solution
Bupivacaine Injectable Solution
Bupivacaine / Epinephrine Cartridge

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1ANDA070552_001RXBUPIVACAINE HYDROCHLORIDE (0.25%)INJECTIONFalseAP1986-05-21SENSORCAINE
2ANDA070553_001RXBUPIVACAINE HYDROCHLORIDE (0.5%)INJECTIONFalseAP1986-05-21SENSORCAINE
3ANDA070554_001RXBUPIVACAINE HYDROCHLORIDE (0.75%)INJECTIONFalseAP1986-05-21SENSORCAINE
4ANDA070583_001RXBUPIVACAINE HYDROCHLORIDE (0.25%)INJECTIONFalseAP1987-02-17BUPIVACAINE HYDROCHLORIDE
5ANDA070584_001RXBUPIVACAINE HYDROCHLORIDE (0.5%)INJECTIONFalseAP1986-02-17BUPIVACAINE HYDROCHLORIDE
6ANDA070585_001RXBUPIVACAINE HYDROCHLORIDE (0.75%)INJECTIONFalseAP1987-03-03BUPIVACAINE HYDROCHLORIDE
7ANDA070586_001RXBUPIVACAINE HYDROCHLORIDE (0.25%)INJECTIONFalseAP1987-03-03BUPIVACAINE HYDROCHLORIDE
8ANDA070587_001discontinuedBUPIVACAINE HYDROCHLORIDE (0.75%)INJECTIONFalse1987-03-03BUPIVACAINE HYDROCHLORIDE
9ANDA070590_001RXBUPIVACAINE HYDROCHLORIDE (0.25%)INJECTIONFalseAP1987-02-17BUPIVACAINE HYDROCHLORIDE
10ANDA070597_001RXBUPIVACAINE HYDROCHLORIDE (0.5%)INJECTIONFalseAP1987-03-03BUPIVACAINE HYDROCHLORIDE
11ANDA070609_001RXBUPIVACAINE HYDROCHLORIDE (0.5%)INJECTIONFalseAP1987-03-03BUPIVACAINE HYDROCHLORIDE
12ANDA070966_001RXBUPIVACAINE HYDROCHLORIDE (0.25%), EPINEPHRINE BITARTRATE (0.0091MG/ML)INJECTIONFalseAP1987-10-13SENSORCAINE
13ANDA070967_001RXBUPIVACAINE HYDROCHLORIDE (0.25%), EPINEPHRINE BITARTRATE (0.0091MG/ML)INJECTIONFalseAP1987-10-13SENSORCAINE
14ANDA070968_001RXEPINEPHRINE BITARTRATE (0.0091MG/ML), BUPIVACAINE HYDROCHLORIDE (0.5%)INJECTIONFalseAP1987-10-13SENSORCAINE
15ANDA071165_001RXBUPIVACAINE HYDROCHLORIDE (0.25%), EPINEPHRINE (0.005MG/ML)INJECTIONTrue1988-06-16BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE
16ANDA071166_001discontinuedEPINEPHRINE (0.005MG/ML), BUPIVACAINE HYDROCHLORIDE (0.25%)INJECTIONFalse1988-06-16BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE
17ANDA071167_001RXBUPIVACAINE HYDROCHLORIDE (0.25%), EPINEPHRINE (0.005MG/ML)INJECTIONFalse1988-06-16BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE
18ANDA071168_001RXBUPIVACAINE HYDROCHLORIDE (0.5%), EPINEPHRINE (0.005MG/ML)INJECTIONTrueAP1988-06-16BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE
19ANDA071169_001discontinuedBUPIVACAINE HYDROCHLORIDE (0.5%), EPINEPHRINE (0.005MG/ML)INJECTIONFalse1988-06-16BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE
20ANDA071170_001RXBUPIVACAINE HYDROCHLORIDE (0.5%), EPINEPHRINE (0.005MG/ML)INJECTIONFalseAP1988-06-16BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE
21ANDA071171_001discontinuedBUPIVACAINE HYDROCHLORIDE (0.75%), EPINEPHRINE (0.005MG/ML)INJECTIONFalse1988-06-16BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE
22ANDA076012_001discontinuedBUPIVACAINE HYDROCHLORIDE (0.25%)INJECTIONFalse2002-01-09BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE
23ANDA076012_002discontinuedBUPIVACAINE HYDROCHLORIDE (0.5%)INJECTIONFalse2002-01-09BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE
24ANDA076012_003discontinuedBUPIVACAINE HYDROCHLORIDE (0.75%)INJECTIONFalse2002-01-09BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE
25ANDA077250_001RXBUPIVACAINE HYDROCHLORIDE (0.5%), EPINEPHRINE BITARTRATE (0.0091MG/ML)INJECTIONFalseAP2006-09-27BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE
26ANDA091487_001RXBUPIVACAINE HYDROCHLORIDE (0.5%)INJECTIONFalseAP2011-10-18BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE
27ANDA091487_002RXBUPIVACAINE HYDROCHLORIDE (0.25%)INJECTIONFalseAP2011-10-18BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE
28ANDA091487_003RXBUPIVACAINE HYDROCHLORIDE (0.75%)INJECTIONFalseAP2011-10-18BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE
29ANDA091503_001RXBUPIVACAINE HYDROCHLORIDE (0.25%)INJECTIONFalseAP2011-10-18BUPIVACAINE HYDROCHLORIDE
30ANDA091503_002RXBUPIVACAINE HYDROCHLORIDE (0.5%)INJECTIONFalseAP2011-10-18BUPIVACAINE HYDROCHLORIDE
31ANDA203895_001RXBUPIVACAINE HYDROCHLORIDE (0.25%)INJECTIONFalseAP2013-11-05BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE
32ANDA203895_002RXBUPIVACAINE HYDROCHLORIDE (0.5%)INJECTIONFalseAP2013-11-05BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE
33ANDA203895_003RXBUPIVACAINE HYDROCHLORIDE (0.75%)INJECTIONFalseAP2013-11-05BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE
34NDA016964_001RXBUPIVACAINE HYDROCHLORIDE (0.25%)INJECTIONTrueAPMARCAINE HYDROCHLORIDE
35NDA016964_004RXEPINEPHRINE BITARTRATE (0.0091MG/ML), BUPIVACAINE HYDROCHLORIDE (0.25%)INJECTIONTrueAPMARCAINE HYDROCHLORIDE
36NDA016964_005RXBUPIVACAINE HYDROCHLORIDE (0.5%)INJECTIONTrueAPMARCAINE HYDROCHLORIDE
37NDA016964_006RXBUPIVACAINE HYDROCHLORIDE (0.5%)INJECTIONTrueAPMARCAINE HYDROCHLORIDE
38NDA016964_007RXEPINEPHRINE BITARTRATE (0.0091MG/ML), BUPIVACAINE HYDROCHLORIDE (0.5%)INJECTIONTrueAPMARCAINE HYDROCHLORIDE
39NDA016964_008RXEPINEPHRINE BITARTRATE (0.0091MG/ML), BUPIVACAINE HYDROCHLORIDE (0.5%)INJECTIONTrueAPMARCAINE HYDROCHLORIDE
40NDA016964_009RXBUPIVACAINE HYDROCHLORIDE (0.75%)INJECTIONTrueAPMARCAINE HYDROCHLORIDE
41NDA016964_010RXEPINEPHRINE BITARTRATE (0.0091MG/ML), BUPIVACAINE HYDROCHLORIDE (0.75%)INJECTIONTrueAPMARCAINE HYDROCHLORIDE
42NDA016964_012RXBUPIVACAINE HYDROCHLORIDE (0.25%)INJECTIONTrueAPMARCAINE HYDROCHLORIDE
43NDA016964_013RXBUPIVACAINE HYDROCHLORIDE (0.25%), EPINEPHRINE BITARTRATE (0.0091MG/ML)INJECTIONTrueAPMARCAINE HYDROCHLORIDE
44NDA018053_001RXBUPIVACAINE HYDROCHLORIDE (0.5%)INJECTIONFalseAPBUPIVACAINE HYDROCHLORIDE
45NDA018053_002RXBUPIVACAINE HYDROCHLORIDE (0.25%)INJECTIONFalseAPBUPIVACAINE HYDROCHLORIDE
46NDA018053_003RXBUPIVACAINE HYDROCHLORIDE (0.75%)INJECTIONFalseAPBUPIVACAINE HYDROCHLORIDE
47NDA018304_001RXBUPIVACAINE HYDROCHLORIDE (0.25%)INJECTIONFalseAPSENSORCAINE
48NDA018304_002RXBUPIVACAINE HYDROCHLORIDE (0.5%)INJECTIONFalseAPSENSORCAINE
49NDA018304_003RXBUPIVACAINE HYDROCHLORIDE (0.75%)INJECTIONFalseAPSENSORCAINE
50NDA018304_004RXBUPIVACAINE HYDROCHLORIDE (0.5%), EPINEPHRINE BITARTRATE (0.0091MG/ML)INJECTIONFalseAP1983-09-02SENSORCAINE
51NDA018304_005RXBUPIVACAINE HYDROCHLORIDE (0.75%), EPINEPHRINE BITARTRATE (0.0091MG/ML)INJECTIONFalseAP1983-09-02SENSORCAINE
52NDA019978_001discontinuedBUPIVACAINE HYDROCHLORIDE (0.075%)INJECTIONFalse1992-09-03BUPIVACAINE HYDROCHLORIDE KIT
53NDA019978_002discontinuedBUPIVACAINE HYDROCHLORIDE (0.114%)INJECTIONFalse1992-09-03BUPIVACAINE HYDROCHLORIDE KIT
54NDA019978_003discontinuedBUPIVACAINE HYDROCHLORIDE (0.23%)INJECTIONFalse1992-09-03BUPIVACAINE HYDROCHLORIDE KIT
55NDA022046_001RXBUPIVACAINE HYDROCHLORIDE (0.5%), EPINEPHRINE BITARTRATE (0.0091MG/ML)INJECTIONTrueAP1983-07-13BUPIVACAINE HYDROCHLORIDE W/EPINEPHRINE

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
102a845c3-4521-4926-e397-25ab536e7cf6 (view SPL)Bupivacaine Hydrochloride Injection, USPprescriptionHuman PrescriptionHospira, Inc.2015-10-2218004099045, 004091158, 004091159, 004091160, 004091161, 004091162, 004091163, 004091165, 004094272, 004094273, 004094274, 004095622, 004095623, 004095757, 004095758, 004099042, 004099043, 004099046Bupivacaine / Epinephrine Injectable Solution
Bupivacaine Injectable Solution
Bupivacaine Prefilled Syringe
267578b56-7540-487e-1fba-481255620e78 (view SPL)prescriptionHuman PrescriptionHospira, Inc.2015-07-2213004091559, 004091560, 004091582, 004091587, 004091610, 004091746, 004091749, 004091752, 004091755Bupivacaine / Epinephrine Injectable Solution
Bupivacaine Injectable Solution
3eb6d8fee-def4-4c96-9972-695e8cea8ea8 (view SPL)SensorcaineprescriptionHuman PrescriptionApp Pharmaceuticals, LlcMANUFACTURE2014-11-036633230462, 633230460, 633230464, 633230465, 633230466, 633230467Bupivacaine / Epinephrine Injectable Solution
Bupivacaine Injectable Solution

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