Fluconazole Injection

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Claris Lifesciences Inc. (2015-06-19)
Oldest Current Product
2004-07-29
License(s)
ANDA
RxNORM
INJECTION\FLUCONAZOLE
FDAOB
INJECTION\INJECTION\FLUCONAZOLE\rdfq
SPL Active
INTRAVENOUS\INJECTION, SOLUTION\FLUCONAZOLE
INTRAVENOUS\INJECTION\FLUCONAZOLE
SPL Moiety
INTRAVENOUS\INJECTION, SOLUTION\FLUCONAZOLE
INTRAVENOUS\INJECTION\FLUCONAZOLE

product(s) by strength(s)

fluconazole 2 mg/ml injection

generic product(s)(s)

#idcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formapplicationspl
1004094684ANDAHospira, Inc.2004-07-29FLUCONAZOLEINTRAVENOUSINJECTION, SOLUTIONANDA076304b3efaffa-9ef9-4a4f-998e-aa7d2eb61fc9
2004094688ANDAHospira, Inc.2004-07-292016-02-01FLUCONAZOLEINTRAVENOUSINJECTION, SOLUTIONANDA076303461c8c92-3126-4754-9aad-6575a312ff2f, b3efaffa-9ef9-4a4f-998e-aa7d2eb61fc9
3250210113ANDASagent Pharmaceuticals2009-09-01FLUCONAZOLEINTRAVENOUSINJECTION, SOLUTIONANDA079104b0172db6-fd8d-4ef3-873d-6c4de6538454

100 ml fluconazole 2 mg/ml injection

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000690038ANDAPfizer Labs2004-07-29FLUCONAZOLEINTRAVENOUSINJECTION, SOLUTIONANDA07676645f027f5-3bd9-4f2e-8626-1526bc559abf
2001439667ANDAWest-Ward Pharmaceutical Corp2012-01-30FLUCONAZOLEINTRAVENOUSINJECTIONANDA078764d3ca59bd-ae00-48ab-89aa-87c7f56e9989
3001439669ANDAWest-Ward Pharmaceutical Corp2012-01-30FLUCONAZOLEINTRAVENOUSINJECTIONANDA078698d3ca59bd-ae00-48ab-89aa-87c7f56e9989
4001439899ANDAWest-Ward Pharmaceutical Corp2005-08-23FLUCONAZOLEINTRAVENOUSINJECTIONANDA076736d3ca59bd-ae00-48ab-89aa-87c7f56e9989
5003386046ANDABaxter Healthcare Corporation2004-07-29FLUCONAZOLEINTRAVENOUSINJECTION, SOLUTIONANDA076766cd24a261-9c15-42b4-8040-89d2dbda174e
6360000002ANDAClaris Lifesciences Inc.2010-06-09FLUCONAZOLEINTRAVENOUSINJECTIONANDA0779099843b969-33e1-4859-8eae-0055bb71d933
7360000004ANDAClaris Lifesciences Inc.2010-06-09FLUCONAZOLEINTRAVENOUSINJECTIONANDA0779479843b969-33e1-4859-8eae-0055bb71d933
8360000006ANDAClaris Lifesciences Inc.2010-06-09FLUCONAZOLEINTRAVENOUSINJECTIONANDA0779889843b969-33e1-4859-8eae-0055bb71d933
9360000287ANDAClaris Lifesciences Inc.2015-02-19FLUCONAZOLEINTRAVENOUSINJECTIONANDA0779099843b969-33e1-4859-8eae-0055bb71d933

200 ml fluconazole 2 mg/ml injection

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000690045ANDAPfizer Labs2004-07-29FLUCONAZOLEINTRAVENOUSINJECTION, SOLUTIONANDA07676645f027f5-3bd9-4f2e-8626-1526bc559abf
2001439666ANDAWest-Ward Pharmaceutical Corp2012-01-30FLUCONAZOLEINTRAVENOUSINJECTIONANDA078764d3ca59bd-ae00-48ab-89aa-87c7f56e9989
3001439668ANDAWest-Ward Pharmaceutical Corp2012-01-30FLUCONAZOLEINTRAVENOUSINJECTIONANDA078698d3ca59bd-ae00-48ab-89aa-87c7f56e9989
4003386045ANDABaxter Healthcare Corporation2004-07-29FLUCONAZOLEINTRAVENOUSINJECTION, SOLUTIONANDA076766cd24a261-9c15-42b4-8040-89d2dbda174e
5360000003ANDAClaris Lifesciences Inc.2010-06-09FLUCONAZOLEINTRAVENOUSINJECTIONANDA0779099843b969-33e1-4859-8eae-0055bb71d933
6360000005ANDAClaris Lifesciences Inc.2010-06-09FLUCONAZOLEINTRAVENOUSINJECTIONANDA0779479843b969-33e1-4859-8eae-0055bb71d933
7360000007ANDAClaris Lifesciences Inc.2010-06-09FLUCONAZOLEINTRAVENOUSINJECTIONANDA0779889843b969-33e1-4859-8eae-0055bb71d933
8360000288ANDAClaris Lifesciences Inc.2015-02-24FLUCONAZOLEINTRAVENOUSINJECTIONANDA0779099843b969-33e1-4859-8eae-0055bb71d933

50 ml fluconazole 2 mg/ml injection

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1360000261ANDAClaris Lifesciences Inc.2010-06-09FLUCONAZOLEINTRAVENOUSINJECTIONANDA0779479843b969-33e1-4859-8eae-0055bb71d933

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA076087FLUCONAZOLE IN SODIUM CHLORIDE 0.9%BEDFORD LABORATORIES DIV BEN VENUE LABORATORIES INC2004-07-29ANDA076087_001, ANDA076087_002, ANDA076087_003
2ANDA076145FLUCONAZOLE IN SODIUM CHLORIDE 0.9%FRESENIUS KABI USA LLC2004-07-29ANDA076145_001, ANDA076145_002
3ANDA076303FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERHOSPIRA INC2004-07-29ANDA076303_001, ANDA076303_002
4ANDA076304FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINERHOSPIRA INC2004-07-29ANDA076304_001, ANDA076304_002
5ANDA076617FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERTrueHOSPIRA INC2004-07-29ANDA076617_001, ANDA076617_002
6ANDA076653FLUCONAZOLE IN SODIUM CHLORIDE 0.9%TEVA PHARMACEUTICALS USA2004-07-29ANDA076653_001, ANDA076653_002
7ANDA076736FLUCONAZOLE IN SODIUM CHLORIDE 0.9%HIKMA FARMACEUTICA PORTUGAL LDA2005-08-23ANDA076736_001
8ANDA076766FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERBAXTER HEALTHCARE CORP2004-07-29ANDA076766_001, ANDA076766_002
9ANDA076837FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERTrueTEVA PHARMACEUTICALS USA2005-01-13ANDA076837_001, ANDA076837_002
10ANDA076888FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINERTrueMYLAN LABORATORIES LTD2005-03-25ANDA076888_001, ANDA076888_002
11ANDA076889FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERTrueMYLAN LABORATORIES LTD2005-03-25ANDA076889_001, ANDA076889_002
12ANDA077909FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERCLARIS PHARMASERVICES2010-05-26ANDA077909_001, ANDA077909_002, ANDA077909_003
13ANDA077947FLUCONAZOLE IN SODIUM CHLORIDE 0.9%CLARIS PHARMASERVICES2010-05-26ANDA077947_001, ANDA077947_002
14ANDA077988FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINERCLARIS PHARMASERVICES2010-05-26ANDA077988_001, ANDA077988_002
15ANDA078107FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERBEDFORD LABORATORIES2008-07-30ANDA078107_001, ANDA078107_002
16ANDA078698FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERHIKMA FARMACEUTICA (PORTUGAL) SA2012-01-30ANDA078698_001, ANDA078698_002
17ANDA078764FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINERHIKMA FARMACEUTICA (PORTUGAL) SA2012-01-30ANDA078764_001, ANDA078764_002
18ANDA079104FLUCANAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERACS DOBFAR INFO SA2009-07-30ANDA079104_001, ANDA079104_002
19NDA019950DIFLUCAN IN DEXTROSE 5% IN PLASTIC CONTAINERPFIZER INC1990-01-29NDA019950_001, NDA019950_002, NDA019950_003, NDA019950_004, NDA019950_005, NDA019950_006

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1ANDA076087_001RXFLUCONAZOLE (200MG/100ML)INJECTIONFalseAP2004-07-29FLUCONAZOLE IN SODIUM CHLORIDE 0.9%
2ANDA076087_002RXFLUCONAZOLE (100MG/50ML)INJECTIONFalse2008-09-26FLUCONAZOLE IN SODIUM CHLORIDE 0.9%
3ANDA076087_003RXFLUCONAZOLE (400MG/200ML)INJECTIONFalseAP2004-07-29FLUCONAZOLE IN SODIUM CHLORIDE 0.9%
4ANDA076145_001RXFLUCONAZOLE (200MG/100ML)INJECTIONFalseAP2004-07-29FLUCONAZOLE IN SODIUM CHLORIDE 0.9%
5ANDA076145_002RXFLUCONAZOLE (400MG/200ML)INJECTIONFalseAP2004-07-29FLUCONAZOLE IN SODIUM CHLORIDE 0.9%
6ANDA076303_001RXFLUCONAZOLE (200MG/100ML)INJECTIONFalseAP2004-07-29FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
7ANDA076303_002RXFLUCONAZOLE (400MG/200ML)INJECTIONFalseAP2004-07-29FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
8ANDA076304_001RXFLUCONAZOLE (200MG/100ML)INJECTIONFalseAP2004-07-29FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER
9ANDA076304_002RXFLUCONAZOLE (400MG/200ML)INJECTIONFalseAP2004-07-29FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER
10ANDA076617_001discontinuedFLUCONAZOLE (200MG/100ML)INJECTIONFalse2004-07-29FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
11ANDA076617_002discontinuedFLUCONAZOLE (400MG/200ML)INJECTIONFalse2004-07-29FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
12ANDA076653_001RXFLUCONAZOLE (200MG/100ML)INJECTIONFalseAP2004-07-29FLUCONAZOLE IN SODIUM CHLORIDE 0.9%
13ANDA076653_002RXFLUCONAZOLE (400MG/200ML)INJECTIONFalseAP2004-07-29FLUCONAZOLE IN SODIUM CHLORIDE 0.9%
14ANDA076736_001RXFLUCONAZOLE (200MG/100ML)INJECTIONFalseAP2005-08-23FLUCONAZOLE IN SODIUM CHLORIDE 0.9%
15ANDA076766_001RXFLUCONAZOLE (200MG/100ML)INJECTIONFalseAP2004-07-29FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
16ANDA076766_002RXFLUCONAZOLE (400MG/200ML)INJECTIONFalseAP2004-07-29FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
17ANDA076837_001discontinuedFLUCONAZOLE (200MG/100ML)INJECTIONFalse2005-01-13FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
18ANDA076837_002discontinuedFLUCONAZOLE (400MG/200ML)INJECTIONFalse2005-01-13FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
19ANDA076888_001discontinuedFLUCONAZOLE (200MG/100ML)INJECTIONFalse2005-03-25FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER
20ANDA076888_002discontinuedFLUCONAZOLE (400MG/200ML)INJECTIONFalse2005-03-25FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER
21ANDA076889_001discontinuedFLUCONAZOLE (200MG/100ML)INJECTIONFalse2005-03-25FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
22ANDA076889_002discontinuedFLUCONAZOLE (400MG/200ML)INJECTIONFalse2005-03-25FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
23ANDA077909_001RXFLUCONAZOLE (200MG/100ML)INJECTIONFalseAP2010-05-26FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
24ANDA077909_002RXFLUCONAZOLE (400MG/200ML)INJECTIONFalseAP2010-05-26FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
25ANDA077909_003RXFLUCONAZOLE (100MG/50ML)INJECTIONFalse2015-04-20FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
26ANDA077947_001RXFLUCONAZOLE (200MG/100ML)INJECTIONFalseAP2010-05-26FLUCONAZOLE IN SODIUM CHLORIDE 0.9%
27ANDA077947_002RXFLUCONAZOLE (400MG/200ML)INJECTIONFalseAP2010-05-26FLUCONAZOLE IN SODIUM CHLORIDE 0.9%
28ANDA077988_001RXFLUCONAZOLE (200MG/100ML)INJECTIONFalseAP2010-05-26FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER
29ANDA077988_002RXFLUCONAZOLE (400MG/200ML)INJECTIONFalseAP2010-05-26FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER
30ANDA078107_001RXFLUCONAZOLE (200MG/100ML)INJECTIONFalseAP2008-07-30FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
31ANDA078107_002RXFLUCONAZOLE (400MG/200ML)INJECTIONFalseAP2008-07-30FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
32ANDA078698_001RXFLUCONAZOLE (200MG/100ML)INJECTIONFalseAP2012-01-30FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
33ANDA078698_002RXFLUCONAZOLE (400MG/200ML)INJECTIONFalseAP2012-01-30FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
34ANDA078764_001RXFLUCONAZOLE (200MG/100ML)INJECTIONFalseAP2012-01-30FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER
35ANDA078764_002RXFLUCONAZOLE (400MG/200ML)INJECTIONFalseAP2012-01-30FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER
36ANDA079104_001RXFLUCONAZOLE (200MG/100ML)INJECTIONFalseAP2009-07-30FLUCANAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
37ANDA079104_002RXFLUCONAZOLE (400MG/200ML)INJECTIONFalseAP2009-07-30FLUCANAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
38NDA019950_001RXFLUCONAZOLE (200MG/100ML)INJECTIONTrueAP1990-01-29DIFLUCAN IN DEXTROSE 5% IN PLASTIC CONTAINER
39NDA019950_002RXFLUCONAZOLE (200MG/100ML)INJECTIONTrueAP1990-01-29DIFLUCAN IN DEXTROSE 5% IN PLASTIC CONTAINER
40NDA019950_003RXFLUCONAZOLE (200MG/100ML)INJECTIONTrueAP1992-09-29DIFLUCAN IN DEXTROSE 5% IN PLASTIC CONTAINER
41NDA019950_004RXFLUCONAZOLE (400MG/200ML)INJECTIONTrueAP1990-01-29DIFLUCAN IN DEXTROSE 5% IN PLASTIC CONTAINER
42NDA019950_005RXFLUCONAZOLE (400MG/200ML)INJECTIONTrueAP1994-07-08DIFLUCAN IN DEXTROSE 5% IN PLASTIC CONTAINER
43NDA019950_006RXFLUCONAZOLE (400MG/200ML)INJECTIONTrueAP1990-01-29DIFLUCAN IN DEXTROSE 5% IN PLASTIC CONTAINER

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
145f027f5-3bd9-4f2e-8626-1526bc559abf (view SPL)Fluconazole Injection, USP For intraveneous infusion only in INTRAVIA Plastic ContainerprescriptionHuman PrescriptionPfizer LabsANALYSIS, LABEL, MANUFACTURE, PACK, STERILIZE2014-06-234000690038, 000690045
2461c8c92-3126-4754-9aad-6575a312ff2f (view SPL)Fluconazole InjectionRx onlyprescriptionHuman PrescriptionHospira, Inc.2014-12-041004094688
39843b969-33e1-4859-8eae-0055bb71d933 (view SPL)Fluconazole Injection, USP For Intravenous Use OnlyRx onlyprescriptionHuman PrescriptionClaris Lifesciences Inc.manufacture2015-06-1910360000002, 360000003, 360000004, 360000005, 360000006, 360000007, 360000261, 360000287, 360000288
4b0172db6-fd8d-4ef3-873d-6c4de6538454 (view SPL)FLUCONAZOLE INJECTION, USP(in 0.9% Sodium Chloride)For Intravenous Infusion onlyprescriptionHuman PrescriptionSagent Pharmaceuticals2015-04-0912250210113
5b3efaffa-9ef9-4a4f-998e-aa7d2eb61fc9 (view SPL)FluconazoleprescriptionHuman PrescriptionHospira, Inc.2014-11-0612004094684, 004094688
6cd24a261-9c15-42b4-8040-89d2dbda174e (view SPL)Fluconazole Injection, USP For intravenous infusion only in INTRAVIA Plastic ContainerprescriptionHuman PrescriptionBaxter Healthcare CorporationANALYSIS, LABEL, MANUFACTURE, PACK, STERILIZE2014-06-236003386045, 003386046
7d3ca59bd-ae00-48ab-89aa-87c7f56e9989 (view SPL)FLUCONAZOLE INJECTION, USPprescriptionHuman PrescriptionWest-Ward Pharmaceutical CorpANALYSIS, LABEL, MANUFACTURE, PACK2015-06-199001439666, 001439667, 001439668, 001439669, 001439899

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