Ciprofloxacin Injection

Brand(s)
Cipro
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Bayer Healthcare Pharmaceuticals Inc. (2015-03-17)
Oldest Current Product
2006-08-28
License(s)
NDA, ANDA
RxNORM
INJECTION\CIPROFLOXACIN
FDAOB
INJECTION\INJECTION\CIPROFLOXACIN\rdfq
SPL Active
INTRAVENOUS\INJECTION, SOLUTION, CONCENTRATE\CIPROFLOXACIN
INTRAVENOUS\INJECTION, SOLUTION\CIPROFLOXACIN
INTRAVENOUS\INJECTION\CIPROFLOXACIN
INTRAVENOUS\SOLUTION, CONCENTRATE\CIPROFLOXACIN
SPL Moiety
INTRAVENOUS\INJECTION, SOLUTION, CONCENTRATE\CIPROFLOXACIN
INTRAVENOUS\INJECTION, SOLUTION\CIPROFLOXACIN
INTRAVENOUS\INJECTION\CIPROFLOXACIN
INTRAVENOUS\SOLUTION, CONCENTRATE\CIPROFLOXACIN

product(s) by strength(s)

40 ml ciprofloxacin 10 mg/ml injection

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000693342ANDAPfizer Labs2009-09-11CIPROFLOXACININTRAVENOUSINJECTION, SOLUTION, CONCENTRATEANDA0780627217ffdd-bcd2-48b7-a397-da966ea533bd
2004094778ANDAHospira, Inc.2006-08-28CIPROFLOXACININTRAVENOUSINJECTION, SOLUTION, CONCENTRATEANDA077245a341d31b-a011-457a-76a1-a96146d2924e
3360000011ANDAClaris Lifesciences Inc.2009-09-17CIPROFLOXACININTRAVENOUSINJECTION, SOLUTION, CONCENTRATEANDA078062e82f52f2-ecf8-4c04-a206-f3253b265903

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1216950914ANDARebel Distributors Corp2009-12-08CIPROFLOXACININTRAVENOUSINJECTION, SOLUTION, CONCENTRATE004094778ANDA077245d4730085-b38e-43ce-bb51-2532da0a3e2b

20 ml ciprofloxacin 10 mg/ml injection

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000693241ANDAPfizer Labs2009-09-11CIPROFLOXACININTRAVENOUSINJECTION, SOLUTION, CONCENTRATEANDA0780627217ffdd-bcd2-48b7-a397-da966ea533bd
2004094765ANDAHospira, Inc.2006-08-28CIPROFLOXACININTRAVENOUSINJECTION, SOLUTION, CONCENTRATEANDA077245a341d31b-a011-457a-76a1-a96146d2924e
3360000010ANDAClaris Lifesciences Inc.2009-09-17CIPROFLOXACININTRAVENOUSINJECTION, SOLUTION, CONCENTRATEANDA078062e82f52f2-ecf8-4c04-a206-f3253b265903

invalid application product(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1216950422ANDARebel Distributors Corp2006-08-28CIPROFLOXACININTRAVENOUSINJECTION007030956ANDA07778219df63de-9f44-40ce-9a4f-0c96345b8a23

ciprofloxacin 2 mg/ml injection

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004094777ANDAHospira, Inc.2008-03-18CIPROFLOXACININTRAVENOUSINJECTION, SOLUTIONANDA07775365fff92f-b51b-4f5e-20bd-b651e613578d, 9deb95f4-83a0-4928-a55d-41f7f02bb3f3
2250210114ANDASagent Pharmaceuticals2008-03-24CIPROFLOXACININTRAVENOUSINJECTION, SOLUTIONANDA0782527049f870-6741-4a67-8033-398c36126a06

200 ml ciprofloxacin 2 mg/ml injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1504190759CiproNDABayer Healthcare Pharmaceuticals Inc.2009-04-22CIPROFLOXACININTRAVENOUSSOLUTION, CONCENTRATENDA019857457d7810-23f1-4318-9561-2cd58a9cf973

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000694396ANDAPfizer Labs2009-09-11CIPROFLOXACININTRAVENOUSINJECTION, SOLUTIONANDA0780247217ffdd-bcd2-48b7-a397-da966ea533bd
2007813240ANDASandoz Inc2008-03-24CIPROFLOXACININTRAVENOUSINJECTIONANDA078252231b60f5-4b72-4f8f-a19e-b7068a601c3a
3360000009ANDAClaris Lifesciences Inc.2008-08-04CIPROFLOXACININTRAVENOUSINJECTION, SOLUTIONANDA078024e82f52f2-ecf8-4c04-a206-f3253b265903
4360000030ANDAClaris Lifesciences Inc.2012-10-23CIPROFLOXACININTRAVENOUSINJECTION, SOLUTIONANDA078024e82f52f2-ecf8-4c04-a206-f3253b265903

100 ml ciprofloxacin 2 mg/ml injection

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000694395ANDAPfizer Labs2009-09-11CIPROFLOXACININTRAVENOUSINJECTION, SOLUTIONANDA0780247217ffdd-bcd2-48b7-a397-da966ea533bd
2007813239ANDASandoz Inc2008-03-24CIPROFLOXACININTRAVENOUSINJECTIONANDA078252231b60f5-4b72-4f8f-a19e-b7068a601c3a
3360000008ANDAClaris Lifesciences Inc.2008-08-04CIPROFLOXACININTRAVENOUSINJECTION, SOLUTIONANDA078024e82f52f2-ecf8-4c04-a206-f3253b265903
4360000029ANDAClaris Lifesciences Inc.2008-08-04CIPROFLOXACININTRAVENOUSINJECTION, SOLUTIONANDA078024e82f52f2-ecf8-4c04-a206-f3253b265903

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA076484CIPROFLOXACINTrueFRESENIUS KABI USA LLC2006-08-28ANDA076484_001, ANDA076484_002
2ANDA076717CIPROFLOXACINHIKMA FARMACEUTICA (PORTUGAL) SA2009-12-22ANDA076717_001, ANDA076717_002
3ANDA076757CIPROFLOXACIN IN DEXTROSE 5%TrueHIKMA FARMACEUTICA (PORTUGAL) SA2008-04-21ANDA076757_001
4ANDA076992CIPROFLOXACINTrueBEDFORD LABORATORIES2006-08-28ANDA076992_001, ANDA076992_002
5ANDA076993CIPROFLOXACINTrueBEDFORD LABORATORIES2006-08-28ANDA076993_001
6ANDA077138CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINERTrueTEVA PHARMACEUTICALS USA2008-03-18ANDA077138_001, ANDA077138_002
7ANDA077245CIPROFLOXACINHOSPIRA INC2006-08-28ANDA077245_001, ANDA077245_002
8ANDA077753CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINERHOSPIRA INC2008-03-18ANDA077753_001, ANDA077753_002
9ANDA077782CIPROFLOXACINTrueTEVA PHARMACEUTICALS USA2006-08-28ANDA077782_001, ANDA077782_002
10ANDA077888CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINERTrueBAXTER HEALTHCARE CORP2008-03-18ANDA077888_001, ANDA077888_002
11ANDA078024CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINERCLARIS PHARMASERVICES2008-03-18ANDA078024_001, ANDA078024_002
12ANDA078062CIPROFLOXACINCLARIS PHARMASERVICES2008-04-29ANDA078062_001, ANDA078062_002
13ANDA078114CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINERTrueBEDFORD LABORATORIES DIV BEN VENUE LABORATORIES INC2008-03-18ANDA078114_001, ANDA078114_002
14ANDA078252CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINERACS DOBFAR INFO SA2008-03-18ANDA078252_001, ANDA078252_002
15ANDA078431CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINERHIKMA FARMACEUTICA (PORTUGAL) SA2009-11-18ANDA078431_001
16NDA019847CIPROBAYER HEALTHCARE PHARMACEUTICALS INC1990-12-26NDA019847_001, NDA019847_002, NDA019847_003
17NDA019857CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINERBAYER HEALTHCARE PHARMACEUTICALS INC1990-12-26NDA019857_001, NDA019857_002
18NDA019858CIPRO IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERTrueBAYER PHARMACEUTICALS CORP1990-12-26NDA019858_001

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1ANDA076484_001discontinuedCIPROFLOXACIN (200MG/20ML)INJECTIONFalse2006-08-28CIPROFLOXACIN
2ANDA076484_002discontinuedCIPROFLOXACIN (400MG/40ML)INJECTIONFalse2006-08-28CIPROFLOXACIN
3ANDA076717_001RXCIPROFLOXACIN (200MG/20ML)INJECTIONFalseAP2009-12-22CIPROFLOXACIN
4ANDA076717_002RXCIPROFLOXACIN (400MG/40ML)INJECTIONFalseAP2009-12-22CIPROFLOXACIN
5ANDA076757_001discontinuedCIPROFLOXACIN (200MG/100ML)INJECTIONFalse2008-04-21CIPROFLOXACIN IN DEXTROSE 5%
6ANDA076992_001discontinuedCIPROFLOXACIN (200MG/20ML)INJECTIONFalse2006-08-28CIPROFLOXACIN
7ANDA076992_002discontinuedCIPROFLOXACIN (400MG/40ML)INJECTIONFalse2006-08-28CIPROFLOXACIN
8ANDA076993_001discontinuedCIPROFLOXACIN (1200MG/120ML)INJECTIONFalse2006-08-28CIPROFLOXACIN
9ANDA077138_001discontinuedCIPROFLOXACIN (200MG/100ML)INJECTIONFalse2008-03-18CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
10ANDA077138_002discontinuedCIPROFLOXACIN (400MG/200ML)INJECTIONFalse2008-03-18CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
11ANDA077245_001RXCIPROFLOXACIN (200MG/20ML)INJECTIONFalseAP2006-08-28CIPROFLOXACIN
12ANDA077245_002RXCIPROFLOXACIN (400MG/40ML)INJECTIONFalseAP2006-08-28CIPROFLOXACIN
13ANDA077753_001RXCIPROFLOXACIN (200MG/100ML)INJECTIONFalseAP2008-03-18CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
14ANDA077753_002RXCIPROFLOXACIN (400MG/200ML)INJECTIONFalseAP2008-03-18CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
15ANDA077782_001discontinuedCIPROFLOXACIN (200MG/20ML)INJECTIONFalse2006-08-28CIPROFLOXACIN
16ANDA077782_002discontinuedCIPROFLOXACIN (400MG/40ML)INJECTIONFalse2006-08-28CIPROFLOXACIN
17ANDA077888_001discontinuedCIPROFLOXACIN (200MG/100ML)INJECTIONFalse2008-03-18CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
18ANDA077888_002discontinuedCIPROFLOXACIN (400MG/200ML)INJECTIONFalse2008-03-18CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
19ANDA078024_001RXCIPROFLOXACIN (200MG/100ML)INJECTIONFalseAP2008-03-18CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
20ANDA078024_002RXCIPROFLOXACIN (400MG/200ML)INJECTIONFalseAP2008-03-18CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
21ANDA078062_001RXCIPROFLOXACIN (200MG/20ML)INJECTIONFalseAP2008-04-29CIPROFLOXACIN
22ANDA078062_002RXCIPROFLOXACIN (400MG/40ML)INJECTIONFalseAP2008-04-29CIPROFLOXACIN
23ANDA078114_001discontinuedCIPROFLOXACIN (200MG/100ML)INJECTIONFalse2008-03-18CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
24ANDA078114_002discontinuedCIPROFLOXACIN (400MG/200ML)INJECTIONFalse2008-03-18CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
25ANDA078252_001RXCIPROFLOXACIN (200MG/100ML)INJECTIONFalseAP2008-03-18CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
26ANDA078252_002RXCIPROFLOXACIN (400MG/200ML)INJECTIONFalseAP2008-03-18CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
27ANDA078431_001RXCIPROFLOXACIN (400MG/200ML)INJECTIONFalseAP2009-11-18CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
28NDA019847_001RXCIPROFLOXACIN (400MG/40ML)INJECTIONTrueAP1990-12-26CIPRO
29NDA019847_002RXCIPROFLOXACIN (200MG/20ML)INJECTIONTrueAP1990-12-26CIPRO
30NDA019847_003discontinuedCIPROFLOXACIN (1200MG/120ML)INJECTIONFalse1990-12-26CIPRO
31NDA019857_001RXCIPROFLOXACIN (200MG/100ML)INJECTIONTrueAP1990-12-26CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER
32NDA019857_002RXCIPROFLOXACIN (400MG/200ML)INJECTIONTrueAP1990-12-26CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER
33NDA019858_001discontinuedCIPROFLOXACIN (200MG/100ML)INJECTIONFalse1990-12-26CIPRO IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
119df63de-9f44-40ce-9a4f-0c96345b8a23 (view SPL)Ciprofloxacin Injection, USPprescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2010-12-161216950422
2231b60f5-4b72-4f8f-a19e-b7068a601c3a (view SPL)CIPROFLOXACIN INJECTION, USP For Intravenous InfusionprescriptionHuman PrescriptionSandoz Inc2015-03-1012007813239, 007813240
3457d7810-23f1-4318-9561-2cd58a9cf973 (view SPL)These highlights do not include all the information needed to use CIPRO IV safely and effectively. See full prescribing information for CIPRO IV.CIPRO IV (ciprofloxacin) injection, for intravenous useInitial U.S. Approval: 1990prescriptionHuman PrescriptionBayer Healthcare Pharmaceuticals Inc.MANUFACTURE2015-03-1712504190759
465fff92f-b51b-4f5e-20bd-b651e613578d (view SPL)These highlights do not include all the information needed to use Ciprofloxacin safely and effectively. See full prescribing information for Ciprofloxacin. Ciprofloxacin Injection, USP in 5% Dextrose for intravenous infusion Initial U.S. Approval: 2006prescriptionHuman PrescriptionHospira, Inc.2015-09-299004094777
57049f870-6741-4a67-8033-398c36126a06 (view SPL)These highlights do not include all the information needed to use Ciprofloxacin Injection, USP safely and effectively. See full prescribing information for Ciprofloxacin Injection, USP.Ciprofloxacin Injection, USP, for intravenous useInitial U.S. Approval: 1990prescriptionHuman PrescriptionSagent Pharmaceuticals2015-05-2812250210114
67217ffdd-bcd2-48b7-a397-da966ea533bd (view SPL)ciprofloxacin injection, USP (1% w/v) and ciprofloxacin in dextrose (5%) injection, USP(ciprofloxacin)For Intravenous InfusionprescriptionHuman PrescriptionPfizer Labsanalysis, manufacture2009-09-172000693241, 000693342, 000694395, 000694396
79deb95f4-83a0-4928-a55d-41f7f02bb3f3 (view SPL)These highlights do not include all the information needed to use Ciprofloxacin safely and effectively. See full prescribing information for Ciprofloxacin.Ciprofloxacin Injection, USP in 5% Dextrose for intravenous infusion Initial U.S. Approval: 2006prescriptionHuman PrescriptionHospira, Inc.2015-10-023004094777
8a341d31b-a011-457a-76a1-a96146d2924e (view SPL)These highlights do not include all the information needed to use Ciprofloxacin safely and effectively. See full prescribing information for Ciprofloxacin. Ciprofloxacin Injection, USP for intravenous infusion Initial U.S. Approval: 2006prescriptionHuman PrescriptionHospira, Inc.2015-10-0113004094765, 004094778
9d4730085-b38e-43ce-bb51-2532da0a3e2b (view SPL)Ciprofloxacin Injection, USPprescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2011-01-111216950914
10e82f52f2-ecf8-4c04-a206-f3253b265903 (view SPL)Ciprofloxacin Injection, USP (1% w/v) and Ciprofloxacin in Dextrose (5%) Injection, USP(ciprofloxacin)For Intravenous InfusionprescriptionHuman PrescriptionClaris Lifesciences Inc.2015-07-0111360000008, 360000009, 360000010, 360000011, 360000029, 360000030

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