Cefuroxime Injectable Solution

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
INJECTABLE SOLUTION\CEFUROXIME
FDAOB
INJECTION\INJECTION\CEFUROXIME SODIUM\rdfq
INTRAMUSCULAR, INTRAVENOUS\INJECTION\CEFUROXIME SODIUM\rdfq
INTRAVENOUS\INJECTION\CEFUROXIME SODIUM
SPL Active
INTRAVENOUS\INJECTION, POWDER, FOR SOLUTION\CEFUROXIME
INTRAVENOUS\INJECTION, POWDER, FOR SOLUTION\CEFUROXIME SODIUM
SPL Moiety
INTRAVENOUS\INJECTION, POWDER, FOR SOLUTION\CEFUROXIME

product(s) by strength(s)

cefuroxime 95 mg/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1249870400ZinacefNDACovis Pharmaceuticals, Inc.2013-01-15CEFUROXIME SODIUMINTRAVENOUSINJECTION, POWDER, FOR SOLUTIONNDA0505585aa67341-d2fd-493d-ba58-0a0a573fb64a

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001439569ANDAWest-Ward Pharmaceutical Corp2004-01-09CEFUROXIME SODIUMINTRAVENOUSINJECTION, POWDER, FOR SOLUTIONANDA06504679f5cf6f-a5e2-49a2-9704-fa1bd21338c3
2001439976ANDAWest-Ward Pharmaceutical Corp2004-01-09CEFUROXIME SODIUMINTRAVENOUSINJECTION, POWDER, FOR SOLUTIONANDA06504665daa2aa-cc4a-4eba-b7dc-7a151806865a
3250210120ANDASagent Pharmaceuticals2008-05-01CEFUROXIME SODIUMINTRAVENOUSINJECTION, POWDER, FOR SOLUTIONANDA065046cc834761-8700-4970-ba49-b8ddecb51a1b
4445670712ANDAWg Critical Care, Llc2012-10-04CEFUROXIME SODIUMINTRAVENOUSINJECTION, POWDER, FOR SOLUTIONANDA064124a7b50175-e978-4edd-9d61-593df4806657
5633230354ANDAApp Pharmaceuticals, Llc2010-07-30CEFUROXIMEINTRAVENOUSINJECTION, POWDER, FOR SOLUTIONANDA064124a1c53a0c-78b0-4c6e-b2bc-0ee90cbe9e73

invalid application product(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1662882075ANDASamson Medical Technologies, Llc2010-02-01CEFUROXIME SODIUMINTRAVENOUSINJECTION, POWDER, FOR SOLUTIONANDA06525198ea197c-b3ff-47bc-8d0f-fce91b539959
2662882225ANDASamson Medical Technologies, Llc2010-02-01CEFUROXIME SODIUMINTRAVENOUSINJECTION, POWDER, FOR SOLUTIONANDA06525198ea197c-b3ff-47bc-8d0f-fce91b539959

application(s)

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

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
15aa67341-d2fd-493d-ba58-0a0a573fb64a (view SPL)ZINACEF (cefuroxime for injection) ZINACEF (cefuroxime injection)prescriptionHuman PrescriptionCovis Pharmaceuticals, Inc.2014-10-097249870400, 249870352, 249870354, 249870425, 249870436, 249870437Cefuroxime Injection
265daa2aa-cc4a-4eba-b7dc-7a151806865a (view SPL)CEFUROXIME FOR INJECTION, USPprescriptionHuman PrescriptionWest-Ward Pharmaceutical CorpANALYSIS, LABEL, MANUFACTURE, PACK2015-04-274001439976
379f5cf6f-a5e2-49a2-9704-fa1bd21338c3 (view SPL)CEFUROXIME FOR INJECTION, USPprescriptionHuman PrescriptionWest-Ward Pharmaceutical CorpANALYSIS, LABEL, MANUFACTURE, PACK2015-04-141001439569
498ea197c-b3ff-47bc-8d0f-fce91b539959 (view SPL)Cefuroxime for Injection, USPprescriptionHuman PrescriptionSamson Medical Technologies, LlcMANUFACTURE2010-02-083662882075, 662882225
5a1c53a0c-78b0-4c6e-b2bc-0ee90cbe9e73 (view SPL)Cefuroxime for Injection, USPprescriptionHuman PrescriptionApp Pharmaceuticals, LlcMANUFACTURE2010-08-303633230354
6a7b50175-e978-4edd-9d61-593df4806657 (view SPL)Cefuroxime for Injection, USPprescriptionHuman PrescriptionWg Critical Care, LlcMANUFACTURE2012-10-045445670712
7cc834761-8700-4970-ba49-b8ddecb51a1b (view SPL)CEFUROXIME FOR INJECTION, USPprescriptionHuman PrescriptionSagent PharmaceuticalsMANUFACTURE2010-12-281250210120

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