Cilastatin / Imipenem Injectable Solution

Brand(s)
Primaxin
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Merck Sharp & Dohme Corp. (2014-10-24)
Oldest Current Product
1985-11-26
License(s)
NDA, ANDA
RxNORM
INJECTABLE SOLUTION\CILASTATIN:IMIPENEM
FDAOB
INJECTION\INJECTION\CILASTATIN SODIUM: IMIPENEM\rdfq
INTRAVENOUS\POWDER\CILASTATIN SODIUM: IMIPENEM
SPL Active
INTRAVENOUS\INJECTION, POWDER, FOR SOLUTION\CILASTATIN SODIUM: IMIPENEM
SPL Moiety
INTRAVENOUS\INJECTION, POWDER, FOR SOLUTION\CILASTATIN: IMIPENEM ANHYDROUS

product(s) by strength(s)

cilastatin 2.5 mg/ml / imipenem 2.5 mg/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000063514PrimaxinNDAMerck Sharp & Dohme Corp.1985-11-26CILASTATIN SODIUM, IMIPENEMINTRAVENOUSINJECTION, POWDER, FOR SOLUTIONNDA050587f41d8abd-7792-4918-1b93-bd83ea01955e

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004093508ANDAHospira, Inc.2011-11-17CILASTATIN SODIUM, IMIPENEMINTRAVENOUSINJECTION, POWDER, FOR SOLUTIONANDA090825c2940d3c-762f-4467-97fa-28ba7d2b334b, fe44d24d-55cd-439c-895b-00a38cd59f65

invalid application product(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000063551PrimaxinANDAMerck Sharp & Dohme Corp.1987-01-08CILASTATIN SODIUM, IMIPENEMINTRAVENOUSINJECTION, POWDER, FOR SOLUTIONANDA062756f41d8abd-7792-4918-1b93-bd83ea01955e

cilastatin 5 mg/ml / imipenem 5 mg/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000063516PrimaxinNDAMerck Sharp & Dohme Corp.1985-11-26CILASTATIN SODIUM, IMIPENEMINTRAVENOUSINJECTION, POWDER, FOR SOLUTIONNDA050587f41d8abd-7792-4918-1b93-bd83ea01955e

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004093507ANDAHospira, Inc.2011-11-17CILASTATIN SODIUM, IMIPENEMINTRAVENOUSINJECTION, POWDER, FOR SOLUTIONANDA090825, ANDA0910074b652048-d5e1-48d1-acd4-091c14d9022d, c2940d3c-762f-4467-97fa-28ba7d2b334b, fe44d24d-55cd-439c-895b-00a38cd59f65

invalid application product(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1000063552PrimaxinANDAMerck Sharp & Dohme Corp.1987-01-08CILASTATIN SODIUM, IMIPENEMINTRAVENOUSINJECTION, POWDER, FOR SOLUTIONANDA062756f41d8abd-7792-4918-1b93-bd83ea01955e
2551545019PrimaxinANDACardinal Health1987-01-08CILASTATIN SODIUM, IMIPENEMINTRAVENOUSINJECTION, POWDER, FOR SOLUTION000063552ANDA0627567aa0ce90-156c-4583-ae6d-9ed3595960c8

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1551545030PrimaxinNDACardinal Health1985-11-26CILASTATIN SODIUM, IMIPENEMINTRAVENOUSINJECTION, POWDER, FOR SOLUTION000063516NDA0505877aa0ce90-156c-4583-ae6d-9ed3595960c8
2551549389ANDACardinal Health2012-01-03CILASTATIN SODIUM, IMIPENEMINTRAVENOUSINJECTION, POWDER, FOR SOLUTION633230322ANDA090577389c2e95-6473-4500-ae8c-93faf15ce68e

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA062756PRIMAXINTrueMERCK AND CO INC1987-01-08ANDA062756_001, ANDA062756_002
2ANDA090577IMIPENEM AND CILASTATINACS DOBFAR SPA2011-12-21ANDA090577_001, ANDA090577_002
3ANDA090825IMIPENEM AND CILASTATINHOSPIRA INC2011-11-16ANDA090825_001, ANDA090825_002
4ANDA091007IMIPENEM AND CILASTATINHOSPIRA INC2011-11-16ANDA091007_001
5NDA050587PRIMAXINMERCK AND CO INC1985-11-26NDA050587_001, NDA050587_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA062756_001discontinuedIMIPENEM (250MG/VIAL), CILASTATIN SODIUM (EQ 250MG BASE/VIAL)INJECTIONFalse1987-01-08PRIMAXIN
2ANDA062756_002discontinuedIMIPENEM (500MG/VIAL), CILASTATIN SODIUM (EQ 500MG BASE/VIAL)INJECTIONFalse1987-01-08PRIMAXIN
3ANDA090577_001RXIMIPENEM (250MG/VIAL), CILASTATIN SODIUM (EQ 250MG BASE/VIAL)INTRAVENOUSPOWDERFalseAP2011-12-21IMIPENEM AND CILASTATIN
4ANDA090577_002RXCILASTATIN SODIUM (EQ 500MG BASE/VIAL), IMIPENEM (500MG/VIAL)INTRAVENOUSPOWDERFalseAP2011-12-21IMIPENEM AND CILASTATIN
5ANDA090825_001RXIMIPENEM (250MG/VIAL), CILASTATIN SODIUM (EQ 250MG BASE/VIAL)INTRAVENOUSPOWDERFalseAP2011-11-16IMIPENEM AND CILASTATIN
6ANDA090825_002RXIMIPENEM (500MG/VIAL), CILASTATIN SODIUM (EQ 500MG BASE/VIAL)INTRAVENOUSPOWDERFalseAP2011-11-16IMIPENEM AND CILASTATIN
7ANDA091007_001RXCILASTATIN SODIUM (EQ 500MG BASE/VIAL), IMIPENEM (500MG/VIAL)INTRAVENOUSPOWDERFalseAP2011-11-16IMIPENEM AND CILASTATIN
8NDA050587_001RXCILASTATIN SODIUM (EQ 250MG BASE/VIAL), IMIPENEM (250MG/VIAL)INTRAVENOUSPOWDERTrueAP1985-11-26PRIMAXIN
9NDA050587_002RXIMIPENEM (500MG/VIAL), CILASTATIN SODIUM (EQ 500MG BASE/VIAL)INTRAVENOUSPOWDERTrueAP1985-11-26PRIMAXIN

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1389c2e95-6473-4500-ae8c-93faf15ce68e (view SPL)IMIPENEM AND CILASTATIN FOR INJECTION, USP (I.V.)prescriptionHuman PrescriptionCardinal HealthREPACK2013-04-112551549389
24b652048-d5e1-48d1-acd4-091c14d9022d (view SPL)IMIPE NEM AND CILASTATIN FOR INJECTION, USP I.V.prescriptionHuman PrescriptionHospira, Inc.2015-06-224004093507
37aa0ce90-156c-4583-ae6d-9ed3595960c8 (view SPL)PRIMAXINI.V.(IMIPENEM AND CILASTATIN FOR INJECTION)prescriptionHuman PrescriptionCardinal HealthREPACK2013-04-113551545019, 551545030
4c2940d3c-762f-4467-97fa-28ba7d2b334b (view SPL)IMIPENEM AND CILASTATIN FOR INJECTION, USP (I.V.)prescriptionHuman PrescriptionHospira, Inc.2014-07-1523004093507, 004093508
5f41d8abd-7792-4918-1b93-bd83ea01955e (view SPL)PRIMAXINI.V.(IMIPENEM AND CILASTATIN FOR INJECTION)prescriptionHuman PrescriptionMerck Sharp & Dohme Corp.MANUFACTURE2014-10-2416000063514, 000063516, 000063551, 000063552
6fe44d24d-55cd-439c-895b-00a38cd59f65 (view SPL)IMIPENEM AND CILASTATIN FOR INJECTION, USP (I.V.)prescriptionHuman PrescriptionHospira, Inc.2015-05-2025004093507, 004093508

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