Cefotaxime Injection

Brand(s)
Claforan
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Sanofi-Aventis U.S. Llc (2015-04-30)
Oldest Current Product
1981-03-11
License(s)
NDA, ANDA
RxNORM
INJECTION\CEFOTAXIME
FDAOB
INJECTION\INJECTION\CEFOTAXIME SODIUM\rdfq
SPL Active
INTRAMUSCULAR\INJECTION, POWDER, FOR SOLUTION\CEFOTAXIME SODIUM
INTRAMUSCULAR\INJECTION\CEFOTAXIME SODIUM
SPL Moiety
INTRAMUSCULAR\INJECTION, POWDER, FOR SOLUTION\CEFOTAXIME
INTRAMUSCULAR\INJECTION\CEFOTAXIME

product(s) by strength(s)

cefotaxime 1000 mg injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000390018ClaforanNDASanofi-Aventis U.S. Llc1981-03-11CEFOTAXIME SODIUMINTRAMUSCULARINJECTIONNDA05054706de783b-0762-4031-991e-2e726da33e16

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000390023ClaforanANDASanofi-Aventis U.S. Llc1987-01-13CEFOTAXIME SODIUMINTRAMUSCULARINJECTIONANDA06265906de783b-0762-4031-991e-2e726da33e16
2001439931ANDAWest-Ward Pharmaceutical Corp2002-11-20CEFOTAXIME SODIUMINTRAMUSCULARINJECTION, POWDER, FOR SOLUTIONANDA065072ed23b6bc-32c7-4c50-a53d-313ae78e5623
3556480986ANDAWockhardt Limited2006-08-29CEFOTAXIME SODIUMINTRAMUSCULARINJECTION, POWDER, FOR SOLUTIONANDA065197a401a44e-2c5c-4c4a-81d8-56a3ef9d57f7
4646790986ANDAWockhardt Usa Llc.2006-08-29CEFOTAXIME SODIUMINTRAMUSCULARINJECTION, POWDER, FOR SOLUTIONANDA065197f3c5895f-f54b-43d4-9b38-7bfbdf8335b7

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1525840018ClaforanNDAGeneral Injecatables & Vaccines, Inc2012-06-07CEFOTAXIME SODIUMINTRAMUSCULARINJECTION000390018NDA050547da74aee2-4596-4a41-a061-b9a2a487adb0

cefotaxime 2000 mg injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000390019ClaforanNDASanofi-Aventis U.S. Llc1981-03-11CEFOTAXIME SODIUMINTRAMUSCULARINJECTIONNDA05054706de783b-0762-4031-991e-2e726da33e16

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000390024ClaforanANDASanofi-Aventis U.S. Llc1987-01-13CEFOTAXIME SODIUMINTRAMUSCULARINJECTIONANDA06265906de783b-0762-4031-991e-2e726da33e16
2001439933ANDAWest-Ward Pharmaceutical Corp2002-11-20CEFOTAXIME SODIUMINTRAMUSCULARINJECTION, POWDER, FOR SOLUTIONANDA065072ed23b6bc-32c7-4c50-a53d-313ae78e5623
3556480948ANDAWockhardt Limited2008-06-20CEFOTAXIME SODIUMINTRAMUSCULARINJECTION, POWDER, FOR SOLUTIONANDA065197a401a44e-2c5c-4c4a-81d8-56a3ef9d57f7
4646790948ANDAWockhardt Usa Llc.2008-06-20CEFOTAXIME SODIUMINTRAMUSCULARINJECTION, POWDER, FOR SOLUTIONANDA065197f3c5895f-f54b-43d4-9b38-7bfbdf8335b7

cefotaxime 500 mg injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000390017ClaforanNDASanofi-Aventis U.S. Llc1981-03-11CEFOTAXIME SODIUMINTRAMUSCULARINJECTIONNDA05054706de783b-0762-4031-991e-2e726da33e16

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001439930ANDAWest-Ward Pharmaceutical Corp2002-11-20CEFOTAXIME SODIUMINTRAMUSCULARINJECTION, POWDER, FOR SOLUTIONANDA065072ed23b6bc-32c7-4c50-a53d-313ae78e5623
2556480947ANDAWockhardt Limited2008-06-20CEFOTAXIME SODIUMINTRAMUSCULARINJECTION, POWDER, FOR SOLUTIONANDA065197a401a44e-2c5c-4c4a-81d8-56a3ef9d57f7
3646790947ANDAWockhardt Usa Llc.2008-06-20CEFOTAXIME SODIUMINTRAMUSCULARINJECTION, POWDER, FOR SOLUTIONANDA065197f3c5895f-f54b-43d4-9b38-7bfbdf8335b7
4681800811ANDALupin Pharmaceuticals, Inc.2005-05-27CEFOTAXIME SODIUMINTRAMUSCULARINJECTION, POWDER, FOR SOLUTIONANDA0651244ebb9704-6b9f-4b47-aac4-d54fe34f0b83

application(s)

#idtitledeprecatedapplicantapprovedapproved drugin other drug docs
1ANDA062659CLAFORANSANOFI AVENTIS US LLC1987-01-13ANDA062659_001, ANDA062659_002Cefotaxime Injectable Solution
2ANDA064200CEFOTAXIMETrueFRESENIUS KABI USA LLC2000-03-24ANDA064200_001, ANDA064200_002, ANDA064200_003Cefotaxime Injectable Solution
3ANDA064201CEFOTAXIMETrueFRESENIUS KABI USA LLC2000-03-24ANDA064201_001, ANDA064201_002Cefotaxime Injectable Solution
4ANDA065071CEFOTAXIMEHIKMA FARMACEUTICA LDA2002-11-20ANDA065071_001Cefotaxime Injectable Solution
5ANDA065072CEFOTAXIMEHIKMA FARMACEUTICA LDA2002-11-20ANDA065072_001, ANDA065072_002, ANDA065072_003Cefotaxime Injectable Solution
6ANDA065124CEFOTAXIME SODIUMLUPIN LTD2003-09-24ANDA065124_001, ANDA065124_002, ANDA065124_003Cefotaxime Injectable Solution
7ANDA065197CEFOTAXIMEWOCKHARDT LTD2006-08-29ANDA065197_001, ANDA065197_002, ANDA065197_003Cefotaxime Injectable Solution
8ANDA065290CEFOTAXIME SODIUMHOSPIRA INC2006-08-11ANDA065290_001, ANDA065290_002, ANDA065290_003Cefotaxime Injectable Solution
9ANDA065292CEFOTAXIME SODIUMHOSPIRA INC2006-08-10ANDA065292_001Cefotaxime Injectable Solution
10ANDA065293CEFOTAXIME SODIUMHOSPIRA INC2006-08-10ANDA065293_001, ANDA065293_002Cefotaxime Injectable Solution
11ANDA065348CEFOTAXIME SODIUMTrueCEPHAZONE PHARMA LLC2010-01-25ANDA065348_001Cefotaxime Injectable Solution
12ANDA065516CEFOTAXIME SODIUMTrueAUROBINDO PHARMA LTD2009-11-06ANDA065516_001Cefotaxime Injectable Solution
13ANDA065517CEFOTAXIME SODIUMTrueAUROBINDO PHARMA LTD2009-11-06ANDA065517_001, ANDA065517_002, ANDA065517_003Cefotaxime Injectable Solution
14NDA050547CLAFORANSANOFI AVENTIS US LLCNDA050547_001, NDA050547_002, NDA050547_003, NDA050547_004Cefotaxime Injectable Solution
15NDA050596CLAFORAN IN DEXTROSE 5% IN PLASTIC CONTAINERSANOFI AVENTIS US LLC1985-05-20NDA050596_001, NDA050596_002, NDA050596_003, NDA050596_004Cefotaxime Injectable Solution
16NDA050792CEFOTAXIME AND DEXTROSE 2.4% IN PLASTIC CONTAINERTrueB BRAUN MEDICAL INC2004-07-29NDA050792_001, NDA050792_002Cefotaxime Injectable Solution

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1ANDA062659_001RXCEFOTAXIME SODIUM (EQ 1GM BASE/VIAL)INJECTIONTrueAP1987-01-13CLAFORAN
2ANDA062659_002RXCEFOTAXIME SODIUM (EQ 2GM BASE/VIAL)INJECTIONTrueAP1987-01-13CLAFORAN
3ANDA064200_001discontinuedCEFOTAXIME SODIUM (EQ 500MG BASE/VIAL)INJECTIONFalse2000-03-24CEFOTAXIME
4ANDA064200_002discontinuedCEFOTAXIME SODIUM (EQ 1GM BASE/VIAL)INJECTIONFalse2000-03-24CEFOTAXIME
5ANDA064200_003discontinuedCEFOTAXIME SODIUM (EQ 2GM BASE/VIAL)INJECTIONFalse2000-03-24CEFOTAXIME
6ANDA064201_001discontinuedCEFOTAXIME SODIUM (EQ 10GM BASE/VIAL)INJECTIONFalse2000-03-24CEFOTAXIME
7ANDA064201_002discontinuedCEFOTAXIME SODIUM (EQ 20GM BASE/VIAL)INJECTIONFalse2000-03-24CEFOTAXIME
8ANDA065071_001RXCEFOTAXIME SODIUM (EQ 10GM BASE/VIAL)INJECTIONFalseAP2002-11-20CEFOTAXIME
9ANDA065072_001RXCEFOTAXIME SODIUM (EQ 500MG BASE/VIAL)INJECTIONFalseAP2002-11-20CEFOTAXIME
10ANDA065072_002RXCEFOTAXIME SODIUM (EQ 1GM BASE/VIAL)INJECTIONFalseAP2002-11-20CEFOTAXIME
11ANDA065072_003RXCEFOTAXIME SODIUM (EQ 2GM BASE/VIAL)INJECTIONFalseAP2002-11-20CEFOTAXIME
12ANDA065124_001RXCEFOTAXIME SODIUM (EQ 500MG BASE/VIAL)INJECTIONFalseAP2003-09-24CEFOTAXIME SODIUM
13ANDA065124_002RXCEFOTAXIME SODIUM (EQ 1GM BASE/VIAL)INJECTIONFalseAP2003-09-24CEFOTAXIME SODIUM
14ANDA065124_003RXCEFOTAXIME SODIUM (EQ 2GM BASE/VIAL)INJECTIONFalseAP2003-09-24CEFOTAXIME SODIUM
15ANDA065197_001RXCEFOTAXIME SODIUM (EQ 1GM BASE/VIAL)INJECTIONFalseAP2006-08-29CEFOTAXIME
16ANDA065197_002RXCEFOTAXIME SODIUM (EQ 500MG BASE/VIAL)INJECTIONFalseAP2008-06-20CEFOTAXIME
17ANDA065197_003RXCEFOTAXIME SODIUM (EQ 2GM BASE/VIAL)INJECTIONFalseAP2008-06-20CEFOTAXIME
18ANDA065290_001RXCEFOTAXIME SODIUM (EQ 500MG BASE/VIAL)INJECTIONFalseAP2006-08-11CEFOTAXIME SODIUM
19ANDA065290_002RXCEFOTAXIME SODIUM (EQ 1GM BASE/VIAL)INJECTIONFalseAP2006-08-11CEFOTAXIME SODIUM
20ANDA065290_003RXCEFOTAXIME SODIUM (EQ 2GM BASE/VIAL)INJECTIONFalseAP2006-08-11CEFOTAXIME SODIUM
21ANDA065292_001RXCEFOTAXIME SODIUM (EQ 10GM BASE/VIAL)INJECTIONFalseAP2006-08-10CEFOTAXIME SODIUM
22ANDA065293_001RXCEFOTAXIME SODIUM (EQ 1GM BASE/VIAL)INJECTIONFalseAP2006-08-10CEFOTAXIME SODIUM
23ANDA065293_002RXCEFOTAXIME SODIUM (EQ 2GM BASE/VIAL)INJECTIONFalseAP2006-08-10CEFOTAXIME SODIUM
24ANDA065348_001discontinuedCEFOTAXIME SODIUM (EQ 10GM BASE/VIAL)INJECTIONFalse2010-01-25CEFOTAXIME SODIUM
25ANDA065516_001discontinuedCEFOTAXIME SODIUM (EQ 10GM BASE/VIAL)INJECTIONFalse2009-11-06CEFOTAXIME SODIUM
26ANDA065517_001discontinuedCEFOTAXIME SODIUM (EQ 500MG BASE/VIAL)INJECTIONFalse2009-11-06CEFOTAXIME SODIUM
27ANDA065517_002discontinuedCEFOTAXIME SODIUM (EQ 1GM BASE/VIAL)INJECTIONFalse2009-11-06CEFOTAXIME SODIUM
28ANDA065517_003discontinuedCEFOTAXIME SODIUM (EQ 2GM BASE/VIAL)INJECTIONFalse2009-11-06CEFOTAXIME SODIUM
29NDA050547_001RXCEFOTAXIME SODIUM (EQ 500MG BASE/VIAL)INJECTIONTrueAPCLAFORAN
30NDA050547_002RXCEFOTAXIME SODIUM (EQ 1GM BASE/VIAL)INJECTIONTrueAPCLAFORAN
31NDA050547_003RXCEFOTAXIME SODIUM (EQ 2GM BASE/VIAL)INJECTIONTrueAPCLAFORAN
32NDA050547_004RXCEFOTAXIME SODIUM (EQ 10GM BASE/VIAL)INJECTIONTrueAP1983-12-29CLAFORAN
33NDA050596_001discontinuedCEFOTAXIME SODIUM (EQ 20MG BASE/ML)INJECTIONFalse1985-05-20CLAFORAN IN DEXTROSE 5% IN PLASTIC CONTAINER
34NDA050596_002RXCEFOTAXIME SODIUM (EQ 20MG BASE/ML)INJECTIONTrue1985-05-20CLAFORAN IN DEXTROSE 5% IN PLASTIC CONTAINER
35NDA050596_003discontinuedCEFOTAXIME SODIUM (EQ 40MG BASE/ML)INJECTIONFalse1985-05-20CLAFORAN IN DEXTROSE 5% IN PLASTIC CONTAINER
36NDA050596_004RXCEFOTAXIME SODIUM (EQ 40MG BASE/ML)INJECTIONTrue1985-05-20CLAFORAN IN DEXTROSE 5% IN PLASTIC CONTAINER
37NDA050792_001discontinuedCEFOTAXIME SODIUM (EQ 2GM BASE)INJECTIONFalse2004-07-29CEFOTAXIME AND DEXTROSE 2.4% IN PLASTIC CONTAINER
38NDA050792_002discontinuedCEFOTAXIME SODIUM (EQ 1GM BASE)INJECTIONFalse2004-07-29CEFOTAXIME AND DEXTROSE 2.4% IN PLASTIC CONTAINER

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
106de783b-0762-4031-991e-2e726da33e16 (view SPL)CLAFORAN Sterile (cefotaxime for injection, USP) and Injection (cefotaxime injection, USP)prescriptionHuman PrescriptionSanofi-Aventis U.S. LlcANALYSIS, LABEL, MANUFACTURE, PACK2015-04-3010000390017, 000390018, 000390019, 000390023, 000390024, 000390020, 000390037, 000390038Cefotaxime Injectable Solution
24ebb9704-6b9f-4b47-aac4-d54fe34f0b83 (view SPL)CEFOTAXIME FOR INJECTION USP500 mg, 1 g and 2 gRx onlyprescriptionHuman PrescriptionLupin Pharmaceuticals, Inc.manufacture, pack2015-07-023681800811
3a401a44e-2c5c-4c4a-81d8-56a3ef9d57f7 (view SPL)Prescribing information Cefotaxime for Injection, USP Rx only To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefotaxime for injection and other antibacterial drugs, cefotaxime for injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.prescriptionHuman PrescriptionWockhardt Limitedmanufacture2010-10-191556480947, 556480948, 556480986
4da74aee2-4596-4a41-a061-b9a2a487adb0 (view SPL)ClaforanSterile cefotaxime for injection, USP andInjection cefotaxime injection, USPprescriptionHuman PrescriptionGeneral Injecatables & Vaccines, Inc2014-01-106525840018
5ed23b6bc-32c7-4c50-a53d-313ae78e5623 (view SPL)CEFOTAXIME FOR INJECTION, USPprescriptionHuman PrescriptionWest-Ward Pharmaceutical CorpANALYSIS, LABEL, MANUFACTURE, PACK2014-07-0310001439930, 001439931, 001439933
6f3c5895f-f54b-43d4-9b38-7bfbdf8335b7 (view SPL)Prescribing information Cefotaxime for Injection, USP Rx only To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefotaxime for injection and other antibacterial drugs, cefotaxime for injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.prescriptionHuman PrescriptionWockhardt Usa Llc.manufacture2009-11-201646790947, 646790948, 646790986

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