cefepime Injection

Brand(s)
Maxipime
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Hospira, Inc. (2015-05-22)
Oldest Current Product
1996-01-18
License(s)
NDA, ANDA
RxNORM
INJECTION\CEFEPIME
FDAOB
INJECTION\INJECTION\CEFEPIME HYDROCHLORIDE\rdfq
SPL Active
INTRAMUSCULAR\INJECTION, POWDER, FOR SOLUTION\CEFEPIME HYDROCHLORIDE
INTRAMUSCULAR\INJECTION\CEFEPIME HYDROCHLORIDE
INTRAVENOUS\INJECTION, POWDER, FOR SOLUTION\CEFEPIME HYDROCHLORIDE
INTRAVENOUS\INJECTION, SOLUTION\CEFEPIME HYDROCHLORIDE
INTRAVENOUS\INJECTION\CEFEPIME HYDROCHLORIDE
SPL Moiety
INTRAMUSCULAR\INJECTION, POWDER, FOR SOLUTION\CEFEPIME
INTRAMUSCULAR\INJECTION\CEFEPIME
INTRAVENOUS\INJECTION, POWDER, FOR SOLUTION\CEFEPIME
INTRAVENOUS\INJECTION, SOLUTION\CEFEPIME
INTRAVENOUS\INJECTION\CEFEPIME

product(s) by strength(s)

cefepime 1000 mg injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1002643193NDAB. Braun Medical Inc.2010-05-06CEFEPIME HYDROCHLORIDEINTRAVENOUSINJECTION, SOLUTIONNDA05082157517a0e-ec1b-4605-a7cc-7e3801158ec9
2004090219MaxipimeHospira, Inc.CEFEPIME HYDROCHLORIDEINTRAMUSCULARINJECTION, POWDER, FOR SOLUTIONa96295cf-e652-4f10-9e25-9f2a2cc036f6

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004090809ANDAHospira, Inc.2012-07-30CEFEPIME HYDROCHLORIDEINTRAVENOUSINJECTION, POWDER, FOR SOLUTIONANDA2022687a8cb129-a82d-4cf7-b4aa-46d6298fad15
2007813222ANDASandoz Inc2008-05-01CEFEPIME HYDROCHLORIDEINTRAMUSCULARINJECTION, POWDER, FOR SOLUTIONANDA0654411eb8794e-2502-43cc-8a32-dcba78031f15
3250210121ANDASagent Pharmaceuticals2008-05-01, 2015-07-01CEFEPIME HYDROCHLORIDEINTRAMUSCULARINJECTION, POWDER, FOR SOLUTIONANDA0654415ef1d3af-40fb-4b38-bc71-abac88cb8feb, de477f37-40f6-4295-ae72-a2ee36a8922e
4445670240ANDAWg Critical Care, Llc2014-10-10CEFEPIME HYDROCHLORIDEINTRAMUSCULARINJECTION, POWDER, FOR SOLUTIONANDA0654415fd857e5-591f-44ca-80cf-fd903660b03c
5605050834ANDAApotex Corp2007-06-18CEFEPIME HYDROCHLORIDEINTRAMUSCULARINJECTION, POWDER, FOR SOLUTIONANDA065369e84ca5ed-dff5-4a13-a04f-6aeee4be4bb0
6605056030ANDAApotex Corp2007-06-18CEFEPIME HYDROCHLORIDEINTRAMUSCULARINJECTION, POWDER, FOR SOLUTIONANDA0653699df717ae-2d95-4ae3-bb5d-d1d285e15d26
7633230326ANDAApp Pharmaceuticals, Llc2010-08-30CEFEPIME HYDROCHLORIDEINTRAMUSCULARINJECTION, POWDER, FOR SOLUTIONANDA0654415e1695e0-1310-4cd8-a5da-ad1a7dcd1792

invalid application product(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1007813302ANDASandoz Inc2010-12-21CEFEPIME HYDROCHLORIDEINTRAMUSCULARINJECTIONANDA090291a02a3bfc-8e79-4e59-953e-361f92a3b3f1

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1551541056MaxipimeNDACardinal Health1996-01-18CEFEPIME HYDROCHLORIDEINTRAMUSCULARINJECTION, POWDER, FOR SOLUTION514790054NDA0506796ad768fe-10ec-47d5-9f98-4e396bc6aedb

cefepime 2000 mg injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1002643195NDAB. Braun Medical Inc.2010-05-06CEFEPIME HYDROCHLORIDEINTRAVENOUSINJECTION, SOLUTIONNDA05082157517a0e-ec1b-4605-a7cc-7e3801158ec9
2004090218MaxipimeHospira, Inc.CEFEPIME HYDROCHLORIDEINTRAVENOUSINJECTION, POWDER, FOR SOLUTIONa96295cf-e652-4f10-9e25-9f2a2cc036f6

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004090810ANDAHospira, Inc.2012-07-30CEFEPIME HYDROCHLORIDEINTRAVENOUSINJECTION, POWDER, FOR SOLUTIONANDA2022687a8cb129-a82d-4cf7-b4aa-46d6298fad15
2007813223ANDASandoz Inc2008-05-01CEFEPIME HYDROCHLORIDEINTRAVENOUSINJECTION, POWDER, FOR SOLUTIONANDA0654411eb8794e-2502-43cc-8a32-dcba78031f15
3250210122ANDASagent Pharmaceuticals2008-05-01, 2015-07-01CEFEPIME HYDROCHLORIDEINTRAVENOUSINJECTION, POWDER, FOR SOLUTIONANDA0654415ef1d3af-40fb-4b38-bc71-abac88cb8feb, de477f37-40f6-4295-ae72-a2ee36a8922e
4445670241ANDAWg Critical Care, Llc2014-10-10CEFEPIME HYDROCHLORIDEINTRAVENOUSINJECTION, POWDER, FOR SOLUTIONANDA0654415fd857e5-591f-44ca-80cf-fd903660b03c
5605050681ANDAApotex Corp2007-06-18CEFEPIME HYDROCHLORIDEINTRAVENOUSINJECTION, POWDER, FOR SOLUTIONANDA065369e84ca5ed-dff5-4a13-a04f-6aeee4be4bb0
6605056031ANDAApotex Corp2007-06-18CEFEPIME HYDROCHLORIDEINTRAVENOUSINJECTION, POWDER, FOR SOLUTIONANDA0653699df717ae-2d95-4ae3-bb5d-d1d285e15d26
7633230340ANDAApp Pharmaceuticals, Llc2010-08-30CEFEPIME HYDROCHLORIDEINTRAVENOUSINJECTION, POWDER, FOR SOLUTIONANDA0654415e1695e0-1310-4cd8-a5da-ad1a7dcd1792

invalid application product(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1007813303ANDASandoz Inc2010-12-21CEFEPIME HYDROCHLORIDEINTRAVENOUSINJECTIONANDA090291a02a3bfc-8e79-4e59-953e-361f92a3b3f1

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1551541057MaxipimeNDACardinal Health1996-01-18CEFEPIME HYDROCHLORIDEINTRAVENOUSINJECTION, POWDER, FOR SOLUTION514790055NDA0506796ad768fe-10ec-47d5-9f98-4e396bc6aedb

cefepime 500 mg injection

original product(s)(s)

#idbrandlabeleractive ingredient(s)routedose formspl
1004090221MaxipimeHospira, Inc.CEFEPIME HYDROCHLORIDEINTRAMUSCULARINJECTION, POWDER, FOR SOLUTIONa96295cf-e652-4f10-9e25-9f2a2cc036f6

generic product(s)(s)

#idcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formapplicationspl
1605050678ANDAApotex Corp2007-06-182013-04-09CEFEPIME HYDROCHLORIDEINTRAMUSCULARINJECTION, POWDER, FOR SOLUTIONANDA065369e84ca5ed-dff5-4a13-a04f-6aeee4be4bb0

invalid application product(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1007813301ANDASandoz Inc2010-12-21CEFEPIME HYDROCHLORIDEINTRAMUSCULARINJECTIONANDA090291a02a3bfc-8e79-4e59-953e-361f92a3b3f1

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA065369CEFEPIME HYDROCHLORIDEHOSPIRA INC2007-06-18ANDA065369_001, ANDA065369_002, ANDA065369_003
2ANDA065441CEFEPIME HYDROCHLORIDEACS DOBFAR SPA2008-03-20ANDA065441_001, ANDA065441_002
3ANDA090291CEFEPIME HYDROCHLORIDETrueSANDOZ INC2010-12-21ANDA090291_001, ANDA090291_002, ANDA090291_003
4ANDA202268CEFEPIME HYDROCHLORIDEHOSPIRA INC2012-07-30ANDA202268_001, ANDA202268_002
5NDA050679MAXIPIMEHOSPIRA INC1996-01-18NDA050679_001, NDA050679_002, NDA050679_003
6NDA050817CEFEPIME IN PLASTIC CONTAINERBAXTER HEALTHCARE CORP2008-08-05NDA050817_001, NDA050817_002
7NDA050821CEFEPIME AND DEXTROSE IN DUPLEX CONTAINERB BRAUN MEDICAL INC2010-05-06NDA050821_001, NDA050821_002

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1ANDA065369_001RXCEFEPIME HYDROCHLORIDE (EQ 500MG BASE/VIAL)INJECTIONFalseAP2007-06-18CEFEPIME HYDROCHLORIDE
2ANDA065369_002RXCEFEPIME HYDROCHLORIDE (EQ 1GM BASE/VIAL)INJECTIONFalseAP2007-06-18CEFEPIME HYDROCHLORIDE
3ANDA065369_003RXCEFEPIME HYDROCHLORIDE (EQ 2GM BASE/VIAL)INJECTIONFalseAP2007-06-18CEFEPIME HYDROCHLORIDE
4ANDA065441_001RXCEFEPIME HYDROCHLORIDE (EQ 1GM BASE/VIAL)INJECTIONFalseAP2008-03-20CEFEPIME HYDROCHLORIDE
5ANDA065441_002RXCEFEPIME HYDROCHLORIDE (EQ 2GM BASE/VIAL)INJECTIONFalseAP2008-03-20CEFEPIME HYDROCHLORIDE
6ANDA090291_001discontinuedCEFEPIME HYDROCHLORIDE (EQ 500MG BASE/VIAL)INJECTIONFalse2010-12-21CEFEPIME HYDROCHLORIDE
7ANDA090291_002discontinuedCEFEPIME HYDROCHLORIDE (EQ 1GM BASE/VIAL)INJECTIONFalse2010-12-21CEFEPIME HYDROCHLORIDE
8ANDA090291_003discontinuedCEFEPIME HYDROCHLORIDE (EQ 2GM BASE/VIAL)INJECTIONFalse2010-12-21CEFEPIME HYDROCHLORIDE
9ANDA202268_001RXCEFEPIME HYDROCHLORIDE (EQ 1GM BASE/VIAL)INJECTIONFalseAP2012-07-30CEFEPIME HYDROCHLORIDE
10ANDA202268_002RXCEFEPIME HYDROCHLORIDE (EQ 2GM BASE/VIAL)INJECTIONFalseAP2012-07-30CEFEPIME HYDROCHLORIDE
11NDA050679_001RXCEFEPIME HYDROCHLORIDE (EQ 500MG BASE/VIAL)INJECTIONTrueAP1996-01-18MAXIPIME
12NDA050679_002RXCEFEPIME HYDROCHLORIDE (EQ 1GM BASE/VIAL)INJECTIONTrueAP1996-01-18MAXIPIME
13NDA050679_003RXCEFEPIME HYDROCHLORIDE (EQ 2GM BASE/VIAL)INJECTIONTrueAP1996-01-18MAXIPIME
14NDA050817_001RXCEFEPIME HYDROCHLORIDE (EQ 1GM BASE/50ML)INJECTIONTrue2008-08-05CEFEPIME IN PLASTIC CONTAINER
15NDA050817_002RXCEFEPIME HYDROCHLORIDE (EQ 2GM BASE/100ML)INJECTIONTrue2008-08-05CEFEPIME IN PLASTIC CONTAINER
16NDA050821_001RXCEFEPIME HYDROCHLORIDE (EQ 1GM BASE/VIAL)INJECTIONFalse2010-05-06CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER
17NDA050821_002RXCEFEPIME HYDROCHLORIDE (EQ 2GM BASE/VIAL)INJECTIONFalse2010-05-06CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
11eb8794e-2502-43cc-8a32-dcba78031f15 (view SPL)Cefepime for Injection, USPprescriptionHuman PrescriptionSandoz Inc2015-04-1613007813222, 007813223
257517a0e-ec1b-4605-a7cc-7e3801158ec9 (view SPL)These highlights do not include all the information needed to use CEFEPIME FOR INJECTION USP AND DEXTROSE INJECTION USP safely and effectively. See full prescribing information for CEFEPIME FOR INJECTION USP AND DEXTROSE INJECTION USP. CEFEPIME FOR INJECTION USP AND DEXTROSE INJECTION USP IN DUPLEX CONTAINER, for intravenous useInitial U.S. Approval: 1996prescriptionHuman PrescriptionB. Braun Medical Inc.2015-11-0518002643193, 002643195
35e1695e0-1310-4cd8-a5da-ad1a7dcd1792 (view SPL)CEFEPIME FOR INJECTION, USPprescriptionHuman PrescriptionApp Pharmaceuticals, LlcAPI MANUFACTURE, MANUFACTURE2015-07-275633230326, 633230340
45ef1d3af-40fb-4b38-bc71-abac88cb8feb (view SPL)CEFEPIME FOR INJECTION, USPprescriptionHuman PrescriptionSagent Pharmaceuticals2015-03-132250210121, 250210122
55fd857e5-591f-44ca-80cf-fd903660b03c (view SPL)Cefepime for Injection, USPprescriptionHuman PrescriptionWg Critical Care, Llc2014-10-103445670240, 445670241
66ad768fe-10ec-47d5-9f98-4e396bc6aedb (view SPL)MAXIPIME (Cefepime Hydrochloride, USP) for InjectionprescriptionHuman PrescriptionCardinal HealthREPACK2012-02-022551541056, 551541057
77a8cb129-a82d-4cf7-b4aa-46d6298fad15 (view SPL)Cefepime for Injection, USPprescriptionHuman PrescriptionHospira, Inc.analysis, manufacture2012-08-1015004090809, 004090810
89df717ae-2d95-4ae3-bb5d-d1d285e15d26 (view SPL)Cefepime for Injection, USPprescriptionHuman PrescriptionApotex Corp2013-12-0312605056030, 605056031
9a02a3bfc-8e79-4e59-953e-361f92a3b3f1 (view SPL)Cefepime for Injection, USPprescriptionHuman PrescriptionSandoz Inc2011-10-0717007813301, 007813302, 007813303
10a96295cf-e652-4f10-9e25-9f2a2cc036f6 (view SPL)MAXIPIMETMprescriptionHuman PrescriptionHospira, Inc.2015-05-225004090218, 004090219, 004090221, 004090217, 004090220
11de477f37-40f6-4295-ae72-a2ee36a8922e (view SPL)CEFEPIME FOR INJECTION, USPprescriptionHuman PrescriptionSagent Pharmaceuticals2014-06-1212250210121, 250210122
12e84ca5ed-dff5-4a13-a04f-6aeee4be4bb0 (view SPL)Cefepime for Injection, USPprescriptionHuman PrescriptionApotex Corp2013-12-0313605050678, 605050681, 605050834

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