Ceftriaxone Injectable Solution

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Lupin Pharmaceuticals, Inc. (2015-08-13)
Oldest Current Product
2005-05-17
License(s)
ANDA
RxNORM
INJECTABLE SOLUTION\CEFTRIAXONE
FDAOB
INJECTION\INJECTION\CEFTRIAXONE SODIUM: LIDOCAINE\rdfq
INJECTION\INJECTION\CEFTRIAXONE SODIUM\rdfq
INTRAMUSCULAR, INTRAVENOUS\INJECTION\CEFTRIAXONE SODIUM\rdfq
SPL Active
INTRAVENOUS\INJECTION, POWDER, FOR SOLUTION\CEFTRIAXONE SODIUM
SPL Moiety
INTRAVENOUS\INJECTION, POWDER, FOR SOLUTION\CEFTRIAXONE

product(s) by strength(s)

ceftriaxone 100 mg/ml injectable solution

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001439768ANDAWest-Ward Pharmaceutical Corp2009-08-06CEFTRIAXONE SODIUMINTRAVENOUSINJECTION, POWDER, FOR SOLUTIONANDA065328e38c48f6-4d07-422b-9bb2-3c1025946e86
2004097334ANDAHospira, Inc.2005-05-17CEFTRIAXONE SODIUMINTRAVENOUSINJECTION, POWDER, FOR SOLUTIONANDA065168365fc265-8e6c-432f-9fda-911f5f7fb451
3007813210ANDASandoz Inc2005-05-17CEFTRIAXONE SODIUMINTRAVENOUSINJECTION, POWDER, FOR SOLUTIONANDA06516853df951b-2eee-44b1-bae2-df7ed85bc0ed
4250210108ANDASagent Pharmaceuticals2009-11-05, 2015-07-01CEFTRIAXONE SODIUMINTRAVENOUSINJECTION, POWDER, FOR SOLUTIONANDA0653284d1ad77f-2c6b-4250-82e5-ab3574444e08, 9bcf7973-54fa-487c-99da-db8a92b5e074
5445670703ANDAWg Critical Care, Llc2008-07-24CEFTRIAXONE SODIUMINTRAVENOUSINJECTION, POWDER, FOR SOLUTIONANDA06532886ec0a92-a552-4a6d-9125-a54f95e43392
6605050679ANDAApotex Corp2005-08-02CEFTRIAXONE SODIUMINTRAVENOUSINJECTION, POWDER, FOR SOLUTIONANDA065232338c1b5f-1bb9-43f4-a5db-00e9bf3f7845
7605056103ANDAApotex Corp2005-08-02CEFTRIAXONE SODIUMINTRAVENOUSINJECTION, POWDER, FOR SOLUTIONANDA065232338c1b5f-1bb9-43f4-a5db-00e9bf3f7845
8633230348ANDAApp Pharmaceuticals, Llc2011-06-20CEFTRIAXONE SODIUMINTRAVENOUSINJECTION, POWDER, FOR SOLUTIONANDA0653288828d4c9-6e71-4d0a-9ca1-bd0d231184ab
9662886100ANDASamson Medical Technologies, Llc2014-06-30CEFTRIAXONE SODIUMINTRAVENOUSINJECTION, POWDER, FOR SOLUTIONANDA0900575cd2d96f-83e5-4326-ae87-d0ede4ba493a
10681800655ANDALupin Pharmaceuticals, Inc.2006-09-12CEFTRIAXONE SODIUMINTRAVENOUSINJECTION, POWDER, FOR SOLUTIONANDA065263750fdf6b-e2b1-4d28-a8b1-81b326c714a2

invalid application product(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1761260007ANDAAgila Specialties Private Limited2013-01-07CEFTRIAXONE SODIUMINTRAVENOUSINJECTION, POWDER, FOR SOLUTIONANDA0910682dd1be9e-74cc-48e8-bf02-f34a78d80fda

application(s)

#idtitledeprecatedapplicantapprovedapproved drugin other drug docs
1ANDA062510ROCEPHINTrueHOFFMANN LA ROCHE INC1985-03-12ANDA062510_001, ANDA062510_002, ANDA062510_003Ceftriaxone Injection
2ANDA062654ROCEPHINTrueHOFFMANN LA ROCHE INC1987-04-30ANDA062654_001, ANDA062654_002, ANDA062654_003Ceftriaxone Injection
3ANDA063239ROCEPHINHOFFMANN LA ROCHE INC1993-08-13ANDA063239_001, ANDA063239_002, ANDA063239_003Ceftriaxone Injection
4ANDA065168CEFTRIAXONESANDOZ INC2005-05-17ANDA065168_001Ceftriaxone Injection
5ANDA065180CEFTRIAXONEWOCKHARDT LTD2006-05-12ANDA065180_001Ceftriaxone Injection
6ANDA065204CEFTRIAXONESANDOZ INC2005-05-03ANDA065204_001, ANDA065204_002Ceftriaxone Injection
7ANDA065224CEFTRIAXONE IN PLASTIC CONTAINERBAXTER HEALTHCARE CORP2005-08-23ANDA065224_001, ANDA065224_002Ceftriaxone Injection
8ANDA065231CEFTRIAXONEHOSPIRA INC2005-08-02ANDA065231_001, ANDA065231_002Ceftriaxone Injection
9ANDA065232CEFTRIAXONEHOSPIRA INC2005-08-02ANDA065232_001Ceftriaxone Injection
10ANDA065252CEFTRIAXONETrueFRESENIUS KABI USA LLC2006-02-15ANDA065252_001Ceftriaxone Injection
11ANDA065263CEFTRIAXONELUPIN LTD2006-09-12ANDA065263_001Ceftriaxone Injection
12ANDA065269CEFTRIAXONEFACTA FARMACEUTICI SPA2007-02-28ANDA065269_001Ceftriaxone Injection
13ANDA065274CEFTRIAXONETrueTEVA PHARMACEUTICALS USA INC2006-05-01ANDA065274_001Ceftriaxone Injection
14ANDA065328CEFTRIAXONEACS DOBFAR SPA2008-07-24ANDA065328_001Ceftriaxone Injection
15ANDA065329CEFTRIAXONEACS DOBFAR SPA2008-07-24ANDA065329_001, ANDA065329_002, ANDA065329_003Ceftriaxone Injection
16ANDA065475CEFTRIAXONEBEDFORD LABORATORIES DIV BEN VENUE LABORATORIES INC2008-08-18ANDA065475_001Ceftriaxone Injection
17ANDA065504CEFTRIAXONETrueAUROBINDO PHARMA LTD2008-07-31ANDA065504_001Ceftriaxone Injection
18ANDA090057CEFTRIAXONESAMSON MEDICAL TECHNOLOGIES LLC2014-04-25ANDA090057_001Ceftriaxone Injection
19ANDA091068CEFTRIAXONETrueAGILA SPECIALTIES PRIVATE LTD2013-01-07ANDA091068_001Ceftriaxone Injection
20ANDA202563CEFTRIAXONEHOSPIRA INC2012-08-20ANDA202563_001, ANDA202563_002Ceftriaxone Injection
21NDA050585ROCEPHINTrueHOFFMANN LA ROCHE INC1984-12-21NDA050585_001, NDA050585_002, NDA050585_003, NDA050585_004, NDA050585_005, NDA050585_006, NDA050585_007Ceftriaxone Injection
22NDA050624ROCEPHIN W/ DEXTROSE IN PLASTIC CONTAINERTrueHOFFMANN LA ROCHE INC1987-02-11NDA050624_001, NDA050624_002, NDA050624_003Ceftriaxone Injection
23NDA050796CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINERB BRAUN MEDICAL INC2005-04-20NDA050796_001, NDA050796_002Ceftriaxone Injection

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1ANDA062510_001discontinuedCEFTRIAXONE SODIUM (EQ 250MG BASE/VIAL)INJECTIONFalse1985-03-12ROCEPHIN
2ANDA062510_002discontinuedCEFTRIAXONE SODIUM (EQ 500MG BASE/VIAL)INJECTIONFalse1985-03-12ROCEPHIN
3ANDA062510_003discontinuedCEFTRIAXONE SODIUM (EQ 1GM BASE/VIAL)INJECTIONFalse1985-03-12ROCEPHIN
4ANDA062654_001discontinuedCEFTRIAXONE SODIUM (EQ 500MG BASE/VIAL)INJECTIONFalse1987-04-30ROCEPHIN
5ANDA062654_002discontinuedCEFTRIAXONE SODIUM (EQ 1GM BASE/VIAL)INJECTIONFalse1987-04-30ROCEPHIN
6ANDA062654_003discontinuedCEFTRIAXONE SODIUM (EQ 2GM BASE/VIAL)INJECTIONFalse1987-04-30ROCEPHIN
7ANDA063239_001discontinuedCEFTRIAXONE SODIUM (EQ 250MG BASE/VIAL)INJECTIONFalse1993-08-13ROCEPHIN
8ANDA063239_002RXCEFTRIAXONE SODIUM (EQ 500MG BASE/VIAL)INJECTIONTrueAP1993-08-13ROCEPHIN
9ANDA063239_003RXCEFTRIAXONE SODIUM (EQ 1GM BASE/VIAL)INJECTIONTrueAP1993-08-13ROCEPHIN
10ANDA065168_001RXCEFTRIAXONE SODIUM (EQ 10GM BASE/VIAL)INJECTIONTrueAP2005-05-17CEFTRIAXONE
11ANDA065180_001RXCEFTRIAXONE SODIUM (EQ 1GM BASE/VIAL)INJECTIONFalseAP2006-05-12CEFTRIAXONE
12ANDA065204_001RXCEFTRIAXONE SODIUM (EQ 1GM BASE/VIAL)INJECTIONTrueAP2005-05-03CEFTRIAXONE
13ANDA065204_002RXCEFTRIAXONE SODIUM (EQ 2GM BASE/VIAL)INJECTIONTrueAP2005-05-03CEFTRIAXONE
14ANDA065224_001RXCEFTRIAXONE SODIUM (EQ 20MG BASE/ML)INJECTIONTrue2005-08-23CEFTRIAXONE IN PLASTIC CONTAINER
15ANDA065224_002RXCEFTRIAXONE SODIUM (EQ 40MG BASE/ML)INJECTIONTrue2005-08-23CEFTRIAXONE IN PLASTIC CONTAINER
16ANDA065231_001RXCEFTRIAXONE SODIUM (EQ 1GM BASE/VIAL)INJECTIONFalseAP2005-08-02CEFTRIAXONE
17ANDA065231_002RXCEFTRIAXONE SODIUM (EQ 2GM BASE/VIAL)INJECTIONFalseAP2005-08-02CEFTRIAXONE
18ANDA065232_001RXCEFTRIAXONE SODIUM (EQ 10GM BASE/VIAL)INJECTIONFalseAP2005-08-02CEFTRIAXONE
19ANDA065252_001discontinuedCEFTRIAXONE SODIUM (EQ 10GM BASE/VIAL)INJECTIONFalse2006-02-15CEFTRIAXONE
20ANDA065263_001RXCEFTRIAXONE SODIUM (EQ 10GM BASE/VIAL)INJECTIONFalseAP2006-09-12CEFTRIAXONE
21ANDA065269_001RXCEFTRIAXONE SODIUM (EQ 10GM BASE/VIAL)INJECTIONFalseAP2007-02-28CEFTRIAXONE
22ANDA065274_001discontinuedCEFTRIAXONE SODIUM (EQ 10GM BASE/VIAL)INJECTIONFalse2006-05-01CEFTRIAXONE
23ANDA065328_001RXCEFTRIAXONE SODIUM (EQ 10GM BASE/VIAL)INJECTIONFalseAP2008-07-24CEFTRIAXONE
24ANDA065329_001RXCEFTRIAXONE SODIUM (EQ 500MG BASE/VIAL)INJECTIONFalseAP2008-07-24CEFTRIAXONE
25ANDA065329_002RXCEFTRIAXONE SODIUM (EQ 1GM BASE/VIAL)INJECTIONFalseAP2008-07-24CEFTRIAXONE
26ANDA065329_003RXCEFTRIAXONE SODIUM (EQ 2GM BASE/VIAL)INJECTIONFalseAP2008-07-24CEFTRIAXONE
27ANDA065475_001RXCEFTRIAXONE SODIUM (EQ 10GM BASE/VIAL)INJECTIONFalseAP2008-08-18CEFTRIAXONE
28ANDA065504_001discontinuedCEFTRIAXONE SODIUM (EQ 10GM BASE/VIAL)INJECTIONFalse2008-07-31CEFTRIAXONE
29ANDA090057_001RXCEFTRIAXONE SODIUM (EQ 100GM BASE/VIAL)INJECTIONFalse2014-04-25CEFTRIAXONE
30ANDA091068_001discontinuedCEFTRIAXONE SODIUM (EQ 10GM BASE/VIAL)INJECTIONFalse2013-01-07CEFTRIAXONE
31ANDA202563_001RXCEFTRIAXONE SODIUM (EQ 1GM BASE/VIAL)INJECTIONFalseAP2012-08-20CEFTRIAXONE
32ANDA202563_002RXCEFTRIAXONE SODIUM (EQ 2GM BASE/VIAL)INJECTIONFalseAP2012-08-20CEFTRIAXONE
33NDA050585_001discontinuedCEFTRIAXONE SODIUM (EQ 250MG BASE/VIAL)INJECTIONFalse1984-12-21ROCEPHIN
34NDA050585_002discontinuedCEFTRIAXONE SODIUM (EQ 500MG BASE/VIAL)INJECTIONFalse1984-12-21ROCEPHIN
35NDA050585_003discontinuedCEFTRIAXONE SODIUM (EQ 1GM BASE/VIAL)INJECTIONFalse1984-12-21ROCEPHIN
36NDA050585_004discontinuedCEFTRIAXONE SODIUM (EQ 2GM BASE/VIAL)INJECTIONFalse1984-12-21ROCEPHIN
37NDA050585_005discontinuedCEFTRIAXONE SODIUM (EQ 10GM BASE/VIAL)INJECTIONFalse1984-12-21ROCEPHIN
38NDA050585_006discontinuedLIDOCAINE (N/A,1%), CEFTRIAXONE SODIUM (EQ 1GM BASE/VIAL,N/A)INJECTIONFalse1996-05-08ROCEPHIN
39NDA050585_007discontinuedCEFTRIAXONE SODIUM (EQ 500MG BASE/VIAL,N/A), LIDOCAINE (N/A,1%)INJECTIONFalse1996-05-08ROCEPHIN
40NDA050624_001discontinuedCEFTRIAXONE SODIUM (EQ 10MG BASE/ML)INJECTIONFalse1987-02-11ROCEPHIN W/ DEXTROSE IN PLASTIC CONTAINER
41NDA050624_002discontinuedCEFTRIAXONE SODIUM (EQ 20MG BASE/ML)INJECTIONFalse1987-02-11ROCEPHIN W/ DEXTROSE IN PLASTIC CONTAINER
42NDA050624_003discontinuedCEFTRIAXONE SODIUM (EQ 40MG BASE/ML)INJECTIONFalse1987-02-11ROCEPHIN W/ DEXTROSE IN PLASTIC CONTAINER
43NDA050796_001RXCEFTRIAXONE SODIUM (EQ 1GM BASE/VIAL)INJECTIONTrueAP2005-04-20CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER
44NDA050796_002RXCEFTRIAXONE SODIUM (EQ 2GM BASE/VIAL)INJECTIONTrueAP2005-04-20CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
12dd1be9e-74cc-48e8-bf02-f34a78d80fda (view SPL)Ceftriaxone for Injection, USPprescriptionHuman PrescriptionAgila Specialties Private LimitedAnalysis, Manufacture, Pack, Sterilize2014-06-063761260007
2338c1b5f-1bb9-43f4-a5db-00e9bf3f7845 (view SPL)Ceftriaxone for Injection, USPprescriptionHuman PrescriptionApotex Corpanalysis, api manufacture, manufacture2013-10-2910605050679, 605056103
3365fc265-8e6c-432f-9fda-911f5f7fb451 (view SPL)Ceftriaxone for Injection, USPprescriptionHuman PrescriptionHospira, Inc.2015-07-0618004097334
44d1ad77f-2c6b-4250-82e5-ab3574444e08 (view SPL)CEFTRIAXONE FOR INJECTION, USPprescriptionHuman PrescriptionSagent Pharmaceuticals2013-09-2412250210108
553df951b-2eee-44b1-bae2-df7ed85bc0ed (view SPL)Ceftriaxone for Injection, USPprescriptionHuman PrescriptionSandoz Inc2015-07-0619007813210
65cd2d96f-83e5-4326-ae87-d0ede4ba493a (view SPL)These highlights do not include all the information needed to use Ceftriaxone for Injection, USP safely and effectively. See full prescribing information for Ceftriaxone for Injection, USP. CEFTRIAXONE FOR INJECTION, USP Ceftriaxone for Injection, for intravenous use Initial U.S. Approval: 1984prescriptionHuman PrescriptionSamson Medical Technologies, Llc2014-05-011662886100
7750fdf6b-e2b1-4d28-a8b1-81b326c714a2 (view SPL)Ceftriaxone for Injection USP10 gprescriptionHuman PrescriptionLupin Pharmaceuticals, Inc.manufacture, pack2015-08-134681800655
886ec0a92-a552-4a6d-9125-a54f95e43392 (view SPL)Ceftriaxone for Injection, USPprescriptionHuman PrescriptionWg Critical Care, Llc2012-05-186445670703
98828d4c9-6e71-4d0a-9ca1-bd0d231184ab (view SPL)Ceftriaxone for Injection, USPprescriptionHuman PrescriptionApp Pharmaceuticals, LlcMANUFACTURE2011-06-201633230348
109bcf7973-54fa-487c-99da-db8a92b5e074 (view SPL)CEFTRIAXONE FOR INJECTION, USPprescriptionHuman PrescriptionSagent Pharmaceuticals2015-04-162250210108
11e38c48f6-4d07-422b-9bb2-3c1025946e86 (view SPL)Ceftriaxone for InjectionprescriptionHuman PrescriptionWest-Ward Pharmaceutical Corp2013-07-307001439768

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