Mepivacaine Injectable Solution

Brand(s)
Carbocaine, Polocaine
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Hospira, Inc. (2015-06-15)
Oldest Current Product
1960-03-15
License(s)
NDA, ANDA
RxNORM
INJECTABLE SOLUTION\MEPIVACAINE
FDAOB
INJECTION\INJECTION\LEVONORDEFRIN: MEPIVACAINE HYDROCHLORIDE\rdfq
INJECTION\INJECTION\MEPIVACAINE HYDROCHLORIDE\rdfq
SPL Active
EPIDURAL\INJECTION, SOLUTION\MEPIVACAINE HYDROCHLORIDE
INFILTRATION\INJECTION, SOLUTION\MEPIVACAINE HYDROCHLORIDE
SPL Moiety
EPIDURAL\INJECTION, SOLUTION\MEPIVACAINE
INFILTRATION\INJECTION, SOLUTION\MEPIVACAINE

product(s) by strength(s)

mepivacaine hydrochloride 10 mg/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004091036CarbocaineNDAHospira, Inc.1960-03-15MEPIVACAINE HYDROCHLORIDEEPIDURALINJECTION, SOLUTIONNDA0122506255ce29-25db-4964-309d-10939a436ff4

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1633230260PolocaineANDAApp Pharmaceuticals, Llc2009-07-20MEPIVACAINE HYDROCHLORIDEEPIDURALINJECTION, SOLUTIONANDA089406a27d0815-ae6b-4a21-a8f5-564c01e83814
2633230283PolocaineANDAApp Pharmaceuticals, Llc2009-07-20MEPIVACAINE HYDROCHLORIDEINFILTRATIONINJECTION, SOLUTIONANDA089407a27d0815-ae6b-4a21-a8f5-564c01e83814

mepivacaine hydrochloride 15 mg/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004091041CarbocaineNDAHospira, Inc.1960-03-15MEPIVACAINE HYDROCHLORIDEEPIDURALINJECTION, SOLUTIONNDA0122506255ce29-25db-4964-309d-10939a436ff4

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1633230293PolocaineANDAApp Pharmaceuticals, Llc2009-07-21MEPIVACAINE HYDROCHLORIDEEPIDURALINJECTION, SOLUTIONANDA089408a27d0815-ae6b-4a21-a8f5-564c01e83814

mepivacaine hydrochloride 20 mg/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004092047CarbocaineNDAHospira, Inc.1960-03-15MEPIVACAINE HYDROCHLORIDEINFILTRATIONINJECTION, SOLUTIONNDA0122506255ce29-25db-4964-309d-10939a436ff4

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1633230294PolocaineANDAApp Pharmaceuticals, Llc2009-07-21MEPIVACAINE HYDROCHLORIDEEPIDURALINJECTION, SOLUTIONANDA089409a27d0815-ae6b-4a21-a8f5-564c01e83814
2633230296PolocaineANDAApp Pharmaceuticals, Llc2009-07-20MEPIVACAINE HYDROCHLORIDEINFILTRATIONINJECTION, SOLUTIONANDA089410a27d0815-ae6b-4a21-a8f5-564c01e83814

application(s)

#idtitledeprecatedapplicantapprovedapproved drugin other drug docs
1ANDA040806MEPIVACAINE HYDROCHLORIDEHOSPIRA INC2008-04-28ANDA040806_001Mepivacaine Cartridge
2ANDA080925ISOCAINE HYDROCHLORIDENOVOCOL PHARMACEUTICAL INCANDA080925_001Mepivacaine Cartridge
3ANDA083559MEPIVACAINE HYDROCHLORIDETrueGRAHAM CHEMICAL COANDA083559_001Mepivacaine Cartridge
4ANDA084777ARESTOCAINE HYDROCHLORIDETrueSOLVAY PHARMACEUTICALS1982-04-18ANDA084777_002Mepivacaine Cartridge
5ANDA087509MEPIVACAINE HYDROCHLORIDETrueINTERNATIONAL MEDICATION SYSTEM1982-10-05ANDA087509_001Mepivacaine Cartridge
6ANDA088387SCANDONEST PLAINDEPROCO INC1984-10-10ANDA088387_001Mepivacaine Cartridge
7ANDA088653POLOCAINETrueDENTSPLY PHARMACEUTICAL1984-08-21ANDA088653_001Mepivacaine Cartridge
8ANDA088769MEPIVACAINE HYDROCHLORIDETrueWATSON LABORATORIES INC1984-11-20ANDA088769_001Mepivacaine Cartridge
9ANDA088770MEPIVACAINE HYDROCHLORIDETrueWATSON LABORATORIES INC1984-11-20ANDA088770_001Mepivacaine Cartridge
10ANDA089406POLOCAINE-MPFFRESENIUS KABI USA LLC1986-12-01ANDA089406_001Mepivacaine Cartridge
11ANDA089407POLOCAINEFRESENIUS KABI USA LLC1986-12-01ANDA089407_001Mepivacaine Cartridge
12ANDA089408POLOCAINE-MPFFRESENIUS KABI USA LLC1986-12-01ANDA089408_001Mepivacaine Cartridge
13ANDA089409POLOCAINE-MPFFRESENIUS KABI USA LLC1986-12-01ANDA089409_001Mepivacaine Cartridge
14ANDA089410POLOCAINEFRESENIUS KABI USA LLC1986-12-01ANDA089410_001Mepivacaine Cartridge
15NDA012125CARBOCAINETrueEASTMAN KODAK CONDA012125_002, NDA012125_003Mepivacaine Cartridge
Levonordefrin / Mepivacaine Cartridge
16NDA012250CARBOCAINEHOSPIRA INCNDA012250_001, NDA012250_002, NDA012250_005Mepivacaine Cartridge

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1ANDA040806_001RXMEPIVACAINE HYDROCHLORIDE (3%)INJECTIONFalseAP2008-04-28MEPIVACAINE HYDROCHLORIDE
2ANDA080925_001RXMEPIVACAINE HYDROCHLORIDE (3%)INJECTIONTrueAPISOCAINE HYDROCHLORIDE
3ANDA083559_001discontinuedMEPIVACAINE HYDROCHLORIDE (3%)INJECTIONFalseMEPIVACAINE HYDROCHLORIDE
4ANDA084777_002discontinuedMEPIVACAINE HYDROCHLORIDE (3%)INJECTIONFalse1982-04-18ARESTOCAINE HYDROCHLORIDE
5ANDA087509_001discontinuedMEPIVACAINE HYDROCHLORIDE (1%)INJECTIONFalse1982-10-05MEPIVACAINE HYDROCHLORIDE
6ANDA088387_001RXMEPIVACAINE HYDROCHLORIDE (3%)INJECTIONTrueAP1984-10-10SCANDONEST PLAIN
7ANDA088653_001discontinuedMEPIVACAINE HYDROCHLORIDE (3%)INJECTIONFalse1984-08-21POLOCAINE
8ANDA088769_001discontinuedMEPIVACAINE HYDROCHLORIDE (1%)INJECTIONFalse1984-11-20MEPIVACAINE HYDROCHLORIDE
9ANDA088770_001discontinuedMEPIVACAINE HYDROCHLORIDE (2%)INJECTIONFalse1984-11-20MEPIVACAINE HYDROCHLORIDE
10ANDA089406_001RXMEPIVACAINE HYDROCHLORIDE (1%)INJECTIONFalseAP1986-12-01POLOCAINE-MPF
11ANDA089407_001RXMEPIVACAINE HYDROCHLORIDE (1%)INJECTIONFalseAP1986-12-01POLOCAINE
12ANDA089408_001RXMEPIVACAINE HYDROCHLORIDE (1.5%)INJECTIONFalseAP1986-12-01POLOCAINE-MPF
13ANDA089409_001RXMEPIVACAINE HYDROCHLORIDE (2%)INJECTIONFalseAP1986-12-01POLOCAINE-MPF
14ANDA089410_001RXMEPIVACAINE HYDROCHLORIDE (2%)INJECTIONFalseAP1986-12-01POLOCAINE
15NDA012125_002discontinuedMEPIVACAINE HYDROCHLORIDE (2%), LEVONORDEFRIN (0.05MG/ML)INJECTIONFalseCARBOCAINE
16NDA012125_003discontinuedMEPIVACAINE HYDROCHLORIDE (3%)INJECTIONFalseCARBOCAINE
17NDA012250_001RXMEPIVACAINE HYDROCHLORIDE (1%)INJECTIONTrueAPCARBOCAINE
18NDA012250_002RXMEPIVACAINE HYDROCHLORIDE (2%)INJECTIONTrueAPCARBOCAINE
19NDA012250_005RXMEPIVACAINE HYDROCHLORIDE (1.5%)INJECTIONTrueAPCARBOCAINE

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
16255ce29-25db-4964-309d-10939a436ff4 (view SPL)CarbocaineTM Mepivacaine Hydrochloride Injection, USPprescriptionHuman PrescriptionHospira, Inc.2015-06-155004091036, 004091041, 004092047, 004091038, 004091067
2a27d0815-ae6b-4a21-a8f5-564c01e83814 (view SPL)prescriptionHuman PrescriptionApp Pharmaceuticals, LlcMANUFACTURE2009-09-092633230260, 633230283, 633230293, 633230294, 633230296

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