Cefuroxime Injection

Brand(s)
Zinacef
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Covis Pharmaceuticals, Inc. (2014-10-09)
Oldest Current Product
2004-01-09
License(s)
NDA, ANDA
RxNORM
INJECTION\CEFUROXIME
FDAOB
INJECTION\INJECTION\CEFUROXIME SODIUM\rdfq
INTRAMUSCULAR, INTRAVENOUS\INJECTION\CEFUROXIME SODIUM\rdfq
INTRAVENOUS\INJECTION\CEFUROXIME SODIUM
SPL Active
INTRAMUSCULAR\INJECTION, POWDER, FOR SOLUTION\CEFUROXIME
INTRAMUSCULAR\INJECTION, POWDER, FOR SOLUTION\CEFUROXIME SODIUM
INTRAVENOUS\INJECTION, POWDER, FOR SOLUTION\CEFUROXIME
INTRAVENOUS\INJECTION, POWDER, FOR SOLUTION\CEFUROXIME SODIUM
SPL Moiety
INTRAMUSCULAR\INJECTION, POWDER, FOR SOLUTION\CEFUROXIME
INTRAVENOUS\INJECTION, POWDER, FOR SOLUTION\CEFUROXIME

product(s) by strength(s)

cefuroxime 1500 mg injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1249870354ZinacefNDACovis Pharmaceuticals, Inc.2013-01-15CEFUROXIME SODIUMINTRAVENOUSINJECTION, POWDER, FOR SOLUTIONNDA0505585aa67341-d2fd-493d-ba58-0a0a573fb64a
2249870437ZinacefNDACovis Pharmaceuticals, Inc.2013-01-15CEFUROXIME SODIUMINTRAVENOUSINJECTION, POWDER, FOR SOLUTIONNDA0505585aa67341-d2fd-493d-ba58-0a0a573fb64a

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001439567ANDAWest-Ward Pharmaceutical Corp2004-01-09CEFUROXIME SODIUMINTRAVENOUSINJECTION, POWDER, FOR SOLUTIONANDA06504819902965-d2d6-433f-982d-0095014df4e8
2001439977ANDAWest-Ward Pharmaceutical Corp2004-01-09CEFUROXIME SODIUMINTRAVENOUSINJECTION, POWDER, FOR SOLUTIONANDA065048703cc338-c0b6-4a02-b8db-c27aeff181df
3004090802ANDAHospira, Inc.2009-04-27CEFUROXIME SODIUMINTRAVENOUSINJECTION, POWDER, FOR SOLUTIONANDA0655031fd2babd-4737-45ad-9464-a7479a3816d9
4250210119ANDASagent Pharmaceuticals2008-05-01CEFUROXIME SODIUMINTRAVENOUSINJECTION, POWDER, FOR SOLUTIONANDA0650480a145288-733a-4966-b7ae-dc96eb103d8c
5445670711ANDAWg Critical Care, Llc2012-10-04CEFUROXIME SODIUMINTRAVENOUSINJECTION, POWDER, FOR SOLUTIONANDA064125f4797359-d4a0-4967-86d3-d348518b3fe4
6445670722ANDAWg Critical Care, Llc2012-10-04CEFUROXIME SODIUMINTRAVENOUSINJECTION, POWDER, FOR SOLUTIONANDA064125f4797359-d4a0-4967-86d3-d348518b3fe4
7633230353ANDAApp Pharmaceuticals, Llc2011-05-24CEFUROXIMEINTRAVENOUSINJECTION, POWDER, FOR SOLUTIONANDA06412568e22782-f3a6-4e2c-8612-3f1608547919

cefuroxime 750 mg injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1249870352ZinacefNDACovis Pharmaceuticals, Inc.2013-01-15CEFUROXIME SODIUMINTRAVENOUSINJECTION, POWDER, FOR SOLUTIONNDA0505585aa67341-d2fd-493d-ba58-0a0a573fb64a

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001439568ANDAWest-Ward Pharmaceutical Corp2004-01-09CEFUROXIME SODIUMINTRAMUSCULARINJECTION, POWDER, FOR SOLUTIONANDA06504819902965-d2d6-433f-982d-0095014df4e8
2001439979ANDAWest-Ward Pharmaceutical Corp2004-01-09CEFUROXIME SODIUMINTRAMUSCULARINJECTION, POWDER, FOR SOLUTIONANDA065048703cc338-c0b6-4a02-b8db-c27aeff181df
3250210118ANDASagent Pharmaceuticals2008-05-01CEFUROXIME SODIUMINTRAMUSCULARINJECTION, POWDER, FOR SOLUTIONANDA0650480a145288-733a-4966-b7ae-dc96eb103d8c
4445670710ANDAWg Critical Care, Llc2012-10-04CEFUROXIME SODIUMINTRAMUSCULARINJECTION, POWDER, FOR SOLUTIONANDA064125f4797359-d4a0-4967-86d3-d348518b3fe4
5445670720ANDAWg Critical Care, Llc2012-10-04CEFUROXIME SODIUMINTRAVENOUSINJECTION, POWDER, FOR SOLUTIONANDA064125f4797359-d4a0-4967-86d3-d348518b3fe4
6633230352ANDAApp Pharmaceuticals, Llc2011-05-24CEFUROXIMEINTRAMUSCULARINJECTION, POWDER, FOR SOLUTIONANDA06412568e22782-f3a6-4e2c-8612-3f1608547919

application(s)

#idtitledeprecatedapplicantapprovedapproved drugin other drug docs
1ANDA062590KEFUROX IN PLASTIC CONTAINERTrueELI LILLY AND CO1986-01-10ANDA062590_001, ANDA062590_002Cefuroxime Injectable Solution
2ANDA062591KEFUROXTrueACS DOBFAR SPA1986-01-10ANDA062591_001, ANDA062591_002, ANDA062591_003Cefuroxime Injectable Solution
3ANDA062592KEFUROXTrueELI LILLY AND CO1986-01-10ANDA062592_001, ANDA062592_002Cefuroxime Injectable Solution
4ANDA064035CEFUROXIME SODIUMTrueWATSON LABORATORIES INC1993-02-26ANDA064035_001, ANDA064035_002Cefuroxime Injectable Solution
5ANDA064036CEFUROXIME SODIUMTrueWATSON LABORATORIES INC1993-02-26ANDA064036_001Cefuroxime Injectable Solution
6ANDA064124CEFUROXIME SODIUMFACTA FARMACEUTICI SPA1997-05-30ANDA064124_001Cefuroxime Injectable Solution
7ANDA064125CEFUROXIME SODIUMFACTA FARMACEUTICI SPA1997-05-30ANDA064125_001, ANDA064125_002Cefuroxime Injectable Solution
8ANDA064191CEFUROXIME SODIUMTrueTEVA PHARMACEUTICALS USA1998-04-16ANDA064191_001Cefuroxime Injectable Solution
9ANDA064192CEFUROXIME SODIUMTrueTEVA PHARMACEUTICALS USA1998-04-16ANDA064192_001, ANDA064192_002Cefuroxime Injectable Solution
10ANDA065001CEFUROXIME SODIUMTrueFRESENIUS KABI USA LLC2001-05-30ANDA065001_001, ANDA065001_002Cefuroxime Injectable Solution
11ANDA065002CEFUROXIME SODIUMTrueFRESENIUS KABI USA LLC1998-09-28ANDA065002_001Cefuroxime Injectable Solution
12ANDA065046CEFUROXIME SODIUMHIKMA FARMACEUTICA PORTUGAL LDA2004-01-09ANDA065046_001Cefuroxime Injectable Solution
13ANDA065048CEFUROXIME SODIUMHIKMA FARMACEUTICA PORTUGAL LDA2004-01-09ANDA065048_001, ANDA065048_002Cefuroxime Injectable Solution
14ANDA065251CEFUROXIME SODIUM IN PLASTIC CONTAINERTrueSAMSON MEDICAL TECHNOLOGIES LLC2009-12-30ANDA065251_001, ANDA065251_002Cefuroxime Injectable Solution
15ANDA065483CEFUROXIME SODIUMHOSPIRA INC2008-10-15ANDA065483_001, ANDA065483_002Cefuroxime Injectable Solution
16ANDA065484CEFUROXIME SODIUMHOSPIRA INC2008-10-15ANDA065484_001Cefuroxime Injectable Solution
17ANDA065503CEFUROXIME SODIUMHOSPIRA INC2008-10-15ANDA065503_001Cefuroxime Injectable Solution
18NDA050558ZINACEFCONCORDIA PHARMACEUTICALS INC1983-10-19NDA050558_002, NDA050558_003, NDA050558_004Cefuroxime Injectable Solution
19NDA050643ZINACEF IN PLASTIC CONTAINERCONCORDIA PHARMACEUTICALS INC1989-04-28NDA050643_001, NDA050643_002Cefuroxime Injectable Solution
20NDA050780CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINERB BRAUN MEDICAL INC2001-02-21NDA050780_001, NDA050780_002Cefuroxime Injectable Solution

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA062590_001discontinuedCEFUROXIME SODIUM (EQ 750MG BASE/VIAL)INTRAVENOUSINJECTIONFalse1986-01-10KEFUROX IN PLASTIC CONTAINER
2ANDA062590_002discontinuedCEFUROXIME SODIUM (EQ 1.5GM BASE/VIAL)INJECTIONFalse1986-01-10KEFUROX IN PLASTIC CONTAINER
3ANDA062591_001discontinuedCEFUROXIME SODIUM (EQ 750MG BASE/VIAL)INJECTIONFalse1986-01-10KEFUROX
4ANDA062591_002discontinuedCEFUROXIME SODIUM (EQ 1.5GM BASE/VIAL)INJECTIONFalse1986-01-10KEFUROX
5ANDA062591_003discontinuedCEFUROXIME SODIUM (EQ 7.5GM BASE/VIAL)INJECTIONFalse1987-12-17KEFUROX
6ANDA062592_001discontinuedCEFUROXIME SODIUM (EQ 750MG BASE/VIAL)INTRAVENOUSINJECTIONFalse1986-01-10KEFUROX
7ANDA062592_002discontinuedCEFUROXIME SODIUM (EQ 1.5GM BASE/VIAL)INJECTIONFalse1986-01-10KEFUROX
8ANDA064035_001discontinuedCEFUROXIME SODIUM (EQ 750MG BASE/VIAL)INJECTIONFalse1993-02-26CEFUROXIME SODIUM
9ANDA064035_002discontinuedCEFUROXIME SODIUM (EQ 1.5GM BASE/VIAL)INJECTIONFalse1993-02-26CEFUROXIME SODIUM
10ANDA064036_001discontinuedCEFUROXIME SODIUM (EQ 7.5GM BASE/VIAL)INJECTIONFalse1993-02-26CEFUROXIME SODIUM
11ANDA064124_001RXCEFUROXIME SODIUM (EQ 7.5GM BASE/VIAL)INJECTIONFalseAP1997-05-30CEFUROXIME SODIUM
12ANDA064125_001RXCEFUROXIME SODIUM (EQ 750MG BASE/VIAL)INJECTIONFalseAB1997-05-30CEFUROXIME SODIUM
13ANDA064125_002RXCEFUROXIME SODIUM (EQ 1.5GM BASE/VIAL)INJECTIONFalseAP1997-05-30CEFUROXIME SODIUM
14ANDA064191_001discontinuedCEFUROXIME SODIUM (EQ 7.5GM BASE/VIAL)INJECTIONFalse1998-04-16CEFUROXIME SODIUM
15ANDA064192_001discontinuedCEFUROXIME SODIUM (EQ 1.5GM BASE/VIAL)INJECTIONFalse1998-04-16CEFUROXIME SODIUM
16ANDA064192_002discontinuedCEFUROXIME SODIUM (EQ 750MG BASE/VIAL)INJECTIONFalse1998-04-16CEFUROXIME SODIUM
17ANDA065001_001discontinuedCEFUROXIME SODIUM (EQ 750MG BASE/VIAL)INJECTIONFalse2001-05-30CEFUROXIME SODIUM
18ANDA065001_002discontinuedCEFUROXIME SODIUM (EQ 1.5GM BASE/VIAL)INJECTIONFalse2001-05-30CEFUROXIME SODIUM
19ANDA065002_001discontinuedCEFUROXIME SODIUM (EQ 7.5GM BASE/VIAL)INJECTIONFalse1998-09-28CEFUROXIME SODIUM
20ANDA065046_001RXCEFUROXIME SODIUM (EQ 7.5GM BASE/VIAL)INJECTIONFalseAP2004-01-09CEFUROXIME SODIUM
21ANDA065048_001RXCEFUROXIME SODIUM (EQ 750MG BASE/VIAL)INJECTIONFalseAB2004-01-09CEFUROXIME SODIUM
22ANDA065048_002RXCEFUROXIME SODIUM (EQ 1.5GM BASE/VIAL)INJECTIONFalseAP2004-01-09CEFUROXIME SODIUM
23ANDA065251_001discontinuedCEFUROXIME SODIUM (EQ 75GM BASE/VIAL)INJECTIONFalse2009-12-30CEFUROXIME SODIUM IN PLASTIC CONTAINER
24ANDA065251_002discontinuedCEFUROXIME SODIUM (EQ 225GM BASE/VIAL)INJECTIONFalse2009-12-30CEFUROXIME SODIUM IN PLASTIC CONTAINER
25ANDA065483_001RXCEFUROXIME SODIUM (EQ 750MG BASE/VIAL)INJECTIONFalseAP2008-10-15CEFUROXIME SODIUM
26ANDA065483_002RXCEFUROXIME SODIUM (EQ 1.5GM BASE/VIAL)INJECTIONFalseAP2008-10-15CEFUROXIME SODIUM
27ANDA065484_001RXCEFUROXIME SODIUM (EQ 7.5GM BASE/VIAL)INJECTIONFalseAP2008-10-15CEFUROXIME SODIUM
28ANDA065503_001RXCEFUROXIME SODIUM (EQ 1.5GM BASE/VIAL)INJECTIONFalseAP2008-10-15CEFUROXIME SODIUM
29NDA050558_002RXCEFUROXIME SODIUM (EQ 750MG BASE/VIAL)INJECTIONTrueAB1983-10-19ZINACEF
30NDA050558_003RXCEFUROXIME SODIUM (EQ 1.5GM BASE/VIAL)INJECTIONTrueAP1983-10-19ZINACEF
31NDA050558_004RXCEFUROXIME SODIUM (EQ 7.5GM BASE/VIAL)INJECTIONTrueAP1986-10-23ZINACEF
32NDA050643_001discontinuedCEFUROXIME SODIUM (EQ 15MG BASE/ML)INJECTIONFalse1989-04-28ZINACEF IN PLASTIC CONTAINER
33NDA050643_002RXCEFUROXIME SODIUM (EQ 30MG BASE/ML)INJECTIONTrue1989-04-28ZINACEF IN PLASTIC CONTAINER
34NDA050780_001RXCEFUROXIME SODIUM (EQ 750MG BASE/VIAL)INJECTIONTrueAP2001-02-21CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER
35NDA050780_002RXCEFUROXIME SODIUM (EQ 1.5GM BASE/VIAL)INJECTIONTrueAP2001-02-21CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
10a145288-733a-4966-b7ae-dc96eb103d8c (view SPL)CEFUROXIME FOR INJECTION, USPprescriptionHuman PrescriptionSagent Pharmaceuticals2011-10-213250210118, 250210119
219902965-d2d6-433f-982d-0095014df4e8 (view SPL)CEFUROXIME FOR INJECTION, USPprescriptionHuman PrescriptionWest-Ward Pharmaceutical CorpANALYSIS, LABEL, MANUFACTURE, PACK2015-03-181001439567, 001439568
31fd2babd-4737-45ad-9464-a7479a3816d9 (view SPL)CEFUROXIME FOR INJECTION, USPprescriptionHuman PrescriptionHospira, Inc.2015-08-315004090802
45aa67341-d2fd-493d-ba58-0a0a573fb64a (view SPL)ZINACEF (cefuroxime for injection) ZINACEF (cefuroxime injection)prescriptionHuman PrescriptionCovis Pharmaceuticals, Inc.2014-10-097249870352, 249870354, 249870437, 249870400, 249870425, 249870436Cefuroxime Injectable Solution
568e22782-f3a6-4e2c-8612-3f1608547919 (view SPL)Cefuroxime for Injection, USPprescriptionHuman PrescriptionApp Pharmaceuticals, LlcMANUFACTURE2011-05-242633230352, 633230353
6703cc338-c0b6-4a02-b8db-c27aeff181df (view SPL)CEFUROXIME FOR INJECTION, USPprescriptionHuman PrescriptionWest-Ward Pharmaceutical CorpANALYSIS, LABEL, MANUFACTURE, PACK2015-03-182001439977, 001439979
7f4797359-d4a0-4967-86d3-d348518b3fe4 (view SPL)Cefuroxime for Injection, USPprescriptionHuman PrescriptionWg Critical Care, LlcMANUFACTURE2012-10-049445670710, 445670711, 445670720, 445670722

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