Metronidazole Injectable Solution

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Baxter Healthcare Corporation (2015-07-13)
Oldest Current Product
1981-12-24
License(s)
NDA, ANDA
RxNORM
INJECTABLE SOLUTION\METRONIDAZOLE
FDAOB
INJECTION\INJECTION\METRONIDAZOLE HYDROCHLORIDE\rdfq
INJECTION\INJECTION\METRONIDAZOLE\rdfq
SPL Active
INTRAVENOUS\INJECTION, SOLUTION\METRONIDAZOLE
INTRAVENOUS\SOLUTION\METRONIDAZOLE
SPL Moiety
INTRAVENOUS\INJECTION, SOLUTION\METRONIDAZOLE
INTRAVENOUS\SOLUTION\METRONIDAZOLE

product(s) by strength(s)

metronidazole 5 mg/ml injectable solution

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1002645535NDAB. Braun Medical Inc.1983-09-29METRONIDAZOLEINTRAVENOUSSOLUTIONNDA018900fd191c06-9d3b-4e46-9f79-90f6af614947
2003381055NDABaxter Healthcare Corporation1981-12-24METRONIDAZOLEINTRAVENOUSINJECTION, SOLUTIONNDA018657d2112f37-5080-4a19-bcc3-6386b49abe1d

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000692390ANDAPfizer Labs2008-11-20METRONIDAZOLEINTRAVENOUSINJECTION, SOLUTIONANDA0780849db2ddc3-8193-4efc-bd39-f532ccec47c5
2001439772ANDAWest-Ward Pharmaceutical Corp2009-08-04METRONIDAZOLEINTRAVENOUSINJECTION, SOLUTIONANDA0780846b35138f-491b-46cf-97d3-55f43e651d63
3360000001ANDAClaris Lifesciences Inc.2008-11-20METRONIDAZOLEINTRAVENOUSINJECTION, SOLUTIONANDA078084ecf64245-20b1-4bff-9fcc-b8a16905e27b
4360000028ANDAClaris Lifesciences Inc.2008-11-20METRONIDAZOLEINTRAVENOUSINJECTION, SOLUTIONANDA078084ecf64245-20b1-4bff-9fcc-b8a16905e27b

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1551545175NDACardinal Health1983-09-29METRONIDAZOLEINTRAVENOUSSOLUTION002645535NDA018900a7276a00-bb2f-4876-b58b-f2e953d716e4

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA070004METRONIDAZOLETrueINTERNATIONAL MEDICATION SYSTEMS LTD1985-05-08ANDA070004_001
2ANDA070042METRONIDAZOLETrueWATSON LABORATORIES INC1984-12-20ANDA070042_001
3ANDA070071METRONIDAZOLETrueABRAXIS PHARMACEUTICAL PRODUCTS1984-12-03ANDA070071_001
4ANDA070170METRONIDAZOLETrueWATSON LABORATORIES INC1986-04-01ANDA070170_001
5ANDA078084METRONIDAZOLE IN PLASTIC CONTAINERCLARIS PHARMASERVICES2008-03-31ANDA078084_001
6NDA018353FLAGYL I.V.PFIZER INCNDA018353_001, NDA018353_002
7NDA018657FLAGYL I.V. RTU IN PLASTIC CONTAINERBAXTER HEALTHCARE CORPNDA018657_001
8NDA018674METRO I.V.TrueB BRAUN MEDICAL INC1982-08-31NDA018674_001
9NDA018889METRONIDAZOLETrueABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV1983-11-18NDA018889_001
10NDA018890METRONIDAZOLE IN PLASTIC CONTAINERHOSPIRA INC1983-11-18NDA018890_002
11NDA018900METRO I.V. IN PLASTIC CONTAINERB BRAUN MEDICAL INC1983-09-29NDA018900_001
12NDA018907METRONIDAZOLETrueEUROHEALTH INTERNATIONAL SARL1984-03-30NDA018907_001

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1ANDA070004_001discontinuedMETRONIDAZOLE (500MG/100ML)INJECTIONFalse1985-05-08METRONIDAZOLE
2ANDA070042_001discontinuedMETRONIDAZOLE (500MG/100ML)INJECTIONFalse1984-12-20METRONIDAZOLE
3ANDA070071_001discontinuedMETRONIDAZOLE (500MG/100ML)INJECTIONFalse1984-12-03METRONIDAZOLE
4ANDA070170_001discontinuedMETRONIDAZOLE (500MG/100ML)INJECTIONFalse1986-04-01METRONIDAZOLE
5ANDA078084_001RXMETRONIDAZOLE (500MG/100ML)INJECTIONFalseAP2008-03-31METRONIDAZOLE IN PLASTIC CONTAINER
6NDA018353_001discontinuedMETRONIDAZOLE HYDROCHLORIDE (EQ 500MG BASE/VIAL)INJECTIONFalseFLAGYL I.V.
7NDA018353_002RXMETRONIDAZOLE (500MG/100ML)INJECTIONTrueAPFLAGYL I.V.
8NDA018657_001RXMETRONIDAZOLE (500MG/100ML)INJECTIONTrueAPFLAGYL I.V. RTU IN PLASTIC CONTAINER
9NDA018674_001discontinuedMETRONIDAZOLE (500MG/100ML)INJECTIONFalse1982-08-31METRO I.V.
10NDA018889_001discontinuedMETRONIDAZOLE (500MG/100ML)INJECTIONFalse1983-11-18METRONIDAZOLE
11NDA018890_002RXMETRONIDAZOLE (500MG/100ML)INJECTIONTrueAP1983-11-18METRONIDAZOLE IN PLASTIC CONTAINER
12NDA018900_001RXMETRONIDAZOLE (500MG/100ML)INJECTIONTrueAP1983-09-29METRO I.V. IN PLASTIC CONTAINER
13NDA018907_001discontinuedMETRONIDAZOLE (500MG/100ML)INJECTIONFalse1984-03-30METRONIDAZOLE

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
12cf52b9d-7010-4126-b442-dcae2ddc9310 (view SPL)METRONIDAZOLEprescriptionHuman PrescriptionHospira, Inc.2015-06-222004097811
23dc5f411-3312-4add-8198-161eed98132b (view SPL)METRONIDAZOLEprescriptionHuman PrescriptionHospira, Inc.2015-06-1714004097811
36b35138f-491b-46cf-97d3-55f43e651d63 (view SPL)Metronidazole InjectionprescriptionHuman PrescriptionWest-Ward Pharmaceutical CorpMANUFACTURE2010-02-022001439772
49d762edb-12ac-429d-b1f0-7af5d3b909d4 (view SPL)Metronidazole Injection, USPin Plastic Container VIAFLEX Plus ContainerprescriptionHuman PrescriptionBaxter Healthcare CorporationANALYSIS, LABEL, MANUFACTURE, PACK, STERILIZE2015-07-132003389541
59db2ddc3-8193-4efc-bd39-f532ccec47c5 (view SPL)Metronidazole Injection, USPprescriptionHuman PrescriptionPfizer Labsanalysis, manufacture2010-01-271000692390
6a7276a00-bb2f-4876-b58b-f2e953d716e4 (view SPL)METRONIDAZOLE Injection USP METRONIDAZOLEprescriptionHuman PrescriptionCardinal HealthREPACK2014-08-123551545175
7d2112f37-5080-4a19-bcc3-6386b49abe1d (view SPL)Metronidazole Injection, USP in Plastic Container VIAFLEX Plus ContainerprescriptionHuman PrescriptionBaxter Healthcare CorporationANALYSIS, LABEL, MANUFACTURE, PACK, STERILIZE2015-07-138003381055
8ecf64245-20b1-4bff-9fcc-b8a16905e27b (view SPL)Metronidazole Injection, USPprescriptionHuman PrescriptionClaris Lifesciences Inc.2015-06-2911360000001, 360000028
9fd191c06-9d3b-4e46-9f79-90f6af614947 (view SPL)METRONIDAZOLE Injection USPMETRONIDAZOLEprescriptionHuman PrescriptionB. Braun Medical Inc.2015-07-239002645535

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