cefdinir Oral Suspension

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Sandoz Inc (2012-04-10)
Oldest Current Product
2007-04-06
License(s)
ANDA
RxNORM
ORAL SUSPENSION\CEFDINIR
FDAOB
ORAL\FOR SUSPENSION\CEFDINIR
SPL Active
ORAL\POWDER, FOR SUSPENSION\CEFDINIR
ORAL\POWDER, FOR SUSPENSION\CEFDINIR MONOHYDRATE
SPL Moiety
ORAL\POWDER, FOR SUSPENSION\CEFDINIR

product(s) by strength(s)

cefdinir 25 mg/ml oral suspension

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000934136ANDATeva Pharmaceuticals Usa Inc2007-05-08CEFDINIR MONOHYDRATEORALPOWDER, FOR SUSPENSIONANDA065332a1f49fe1-b511-4f6b-a912-8ae8662d95a5
2007816077ANDASandoz Inc2007-04-06CEFDINIRORALPOWDER, FOR SUSPENSIONANDA0653375fb3c464-ab1a-4e2f-ba7a-9aa59b94ca00
3167140392ANDANorthstar Rx Llc2007-12-14CEFDINIRORALPOWDER, FOR SUSPENSIONANDA065473e49b6477-4c64-41a5-b3a3-37461757a6fd
4420430251ANDAOrchidpharma Inc2013-10-04CEFDINIR MONOHYDRATEORALPOWDER, FOR SUSPENSIONANDA065429542fb9ea-f289-43c3-81fa-555a632e6a45
5658620218ANDAAurobindo Pharma Limited2007-12-14CEFDINIRORALPOWDER, FOR SUSPENSIONANDA06547306fbdb63-d32f-4212-9962-f1de15597dda
6672530012ANDADava Pharmaceuticals, Inc.2014-05-01CEFDINIRORALPOWDER, FOR SUSPENSIONANDA065337c2e19cf4-d7cf-4adc-86de-0bc0144af88d
7681800722ANDALupin Pharmaceuticals, Inc.2007-05-01CEFDINIRORALPOWDER, FOR SUSPENSIONANDA0652597490df67-56c0-4a1c-8533-2107f3e8aea5

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548685768ANDAPhysicians Total Care, Inc.2007-05-08CEFDINIRORALPOWDER, FOR SUSPENSION658620218ANDA065473d9243be5-bd27-4f37-ba8b-9f6f55f8b3e4

cefdinir 50 mg/ml oral suspension

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000934137ANDATeva Pharmaceuticals Usa Inc2007-05-08CEFDINIR MONOHYDRATEORALPOWDER, FOR SUSPENSIONANDA065332a1f49fe1-b511-4f6b-a912-8ae8662d95a5
2007816078ANDASandoz Inc2007-04-06CEFDINIRORALPOWDER, FOR SUSPENSIONANDA0653375fb3c464-ab1a-4e2f-ba7a-9aa59b94ca00
3167140393ANDANorthstar Rx Llc2007-12-14CEFDINIRORALPOWDER, FOR SUSPENSIONANDA065473e49b6477-4c64-41a5-b3a3-37461757a6fd
4420430252ANDAOrchidpharma Inc2013-10-04CEFDINIR MONOHYDRATEORALPOWDER, FOR SUSPENSIONANDA065429542fb9ea-f289-43c3-81fa-555a632e6a45
5658620219ANDAAurobindo Pharma Limited2007-12-14CEFDINIRORALPOWDER, FOR SUSPENSIONANDA06547306fbdb63-d32f-4212-9962-f1de15597dda
6672530013ANDADava Pharmaceuticals, Inc.2014-05-01CEFDINIRORALPOWDER, FOR SUSPENSIONANDA065337c2e19cf4-d7cf-4adc-86de-0bc0144af88d

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1216950622ANDARebel Distributors Corp2007-12-14CEFDINIRORALPOWDER, FOR SUSPENSION658620219ANDA065473a9c339ac-14a5-465e-a4fe-1d361d017ccf
2332610905ANDAAidarex Pharmaceuticals Llc2007-05-01CEFDINIRORALPOWDER, FOR SUSPENSION681800723ANDA0652598640931e-317a-42b4-806a-146f00ddf2a6
3422540127ANDARebel Distributors Corp2007-05-01CEFDINIRORALPOWDER, FOR SUSPENSION681800723ANDA065259a4587ea9-c06b-4603-beea-1ef926a4d0be
4545695918ANDAA-S Medication Solutions Llc2007-05-01CEFDINIRORALPOWDER, FOR SUSPENSION681800723ANDA0652597216bbce-8e20-4b2e-af56-e520e0d5d2c7
5548685769ANDAPhysicians Total Care, Inc.2007-05-09CEFDINIRORALPOWDER, FOR SUSPENSION658620219ANDA065473d9243be5-bd27-4f37-ba8b-9f6f55f8b3e4
6581189974ANDAClinical Solutions Wholesale2007-12-14CEFDINIRORALPOWDER, FOR SUSPENSION658620219ANDA065473ee96536a-cd94-45aa-a5bb-60425b557be7
7682583053ANDADispensing Solutions, Inc.2007-05-01CEFDINIRORALPOWDER, FOR SUSPENSION681800723ANDA0652592c3705f2-0b44-4d38-a7f9-4b392d0a1a45

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA065259CEFDINIRLUPIN LTD2006-05-31ANDA065259_001, ANDA065259_002
2ANDA065332CEFDINIRTEVA PHARMACEUTICALS USA2007-05-04ANDA065332_001, ANDA065332_002
3ANDA065337CEFDINIRSANDOZ INC2007-04-06ANDA065337_001, ANDA065337_002
4ANDA065429CEFDINIRORCHID HEALTHCARE2007-07-18ANDA065429_001, ANDA065429_002
5ANDA065473CEFDINIRAUROBINDO PHARMA LTD2007-12-14ANDA065473_001, ANDA065473_002
6NDA050749OMNICEFTrueABBVIE INC1997-12-04NDA050749_001, NDA050749_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA065259_001RXCEFDINIR (125MG/5ML)ORALFOR SUSPENSIONFalseAB2006-05-31CEFDINIR
2ANDA065259_002RXCEFDINIR (250MG/5ML)ORALFOR SUSPENSIONFalseAB2007-05-07CEFDINIR
3ANDA065332_001RXCEFDINIR (125MG/5ML)ORALFOR SUSPENSIONFalseAB2007-05-04CEFDINIR
4ANDA065332_002RXCEFDINIR (250MG/5ML)ORALFOR SUSPENSIONFalseAB2007-05-04CEFDINIR
5ANDA065337_001RXCEFDINIR (125MG/5ML)ORALFOR SUSPENSIONFalseAB2007-04-06CEFDINIR
6ANDA065337_002RXCEFDINIR (250MG/5ML)ORALFOR SUSPENSIONTrueAB2007-04-06CEFDINIR
7ANDA065429_001RXCEFDINIR (125MG/5ML)ORALFOR SUSPENSIONFalseAB2007-07-18CEFDINIR
8ANDA065429_002RXCEFDINIR (250MG/5ML)ORALFOR SUSPENSIONFalseAB2007-07-18CEFDINIR
9ANDA065473_001RXCEFDINIR (125MG/5ML)ORALFOR SUSPENSIONFalseAB2007-12-14CEFDINIR
10ANDA065473_002RXCEFDINIR (250MG/5ML)ORALFOR SUSPENSIONFalseAB2007-12-14CEFDINIR
11NDA050749_001discontinuedCEFDINIR (125MG/5ML)ORALFOR SUSPENSIONFalse1997-12-04OMNICEF
12NDA050749_002discontinuedCEFDINIR (250MG/5ML)ORALFOR SUSPENSIONFalse2004-07-29OMNICEF

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
106fbdb63-d32f-4212-9962-f1de15597dda (view SPL)CEFDINIR FOR ORAL SUSPENSION, USPRx OnlyprescriptionHuman PrescriptionAurobindo Pharma LimitedANALYSIS, API MANUFACTURE, MANUFACTURE2014-04-087658620218, 658620219
22c3705f2-0b44-4d38-a7f9-4b392d0a1a45 (view SPL)Cefdinir for Oral Suspension USPprescriptionHuman PrescriptionDispensing Solutions, Inc.relabel, repack2012-02-141682583053
3542fb9ea-f289-43c3-81fa-555a632e6a45 (view SPL)prescriptionHuman PrescriptionOrchidpharma Incanalysis, label, manufacture, pack2015-02-253420430251, 420430252
45fb3c464-ab1a-4e2f-ba7a-9aa59b94ca00 (view SPL)Cefdinir for Oral SuspensionprescriptionHuman PrescriptionSandoz Inc2012-04-1012007816077, 007816078
57216bbce-8e20-4b2e-af56-e520e0d5d2c7 (view SPL)Cefdinir for Oral Suspension USPprescriptionHuman PrescriptionA-S Medication Solutions Llcrelabel2013-06-221545695918
67490df67-56c0-4a1c-8533-2107f3e8aea5 (view SPL)Cefdinir for Oral Suspension USPprescriptionHuman PrescriptionLupin Pharmaceuticals, Inc.2011-03-301681800722
78640931e-317a-42b4-806a-146f00ddf2a6 (view SPL)Cefdinir for Oral Suspension USPprescriptionHuman PrescriptionAidarex Pharmaceuticals Llc2012-09-122332610905
8a1f49fe1-b511-4f6b-a912-8ae8662d95a5 (view SPL)CEFDINIR FOR ORAL SUSPENSION USP 4136 4137Rx onlyprescriptionHuman PrescriptionTeva Pharmaceuticals Usa Inc2015-01-067000934136, 000934137
9a4587ea9-c06b-4603-beea-1ef926a4d0be (view SPL)Cefdinir for Oral Suspension USPprescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2012-02-091422540127
10a9c339ac-14a5-465e-a4fe-1d361d017ccf (view SPL)CEFDINIR FOR ORAL SUSPENSIONprescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2011-01-261216950622
11c2e19cf4-d7cf-4adc-86de-0bc0144af88d (view SPL)CEFDINIR for ORAL SUSPENSIONprescriptionHuman PrescriptionDava Pharmaceuticals, Inc.2014-02-1310672530012, 672530013
12d9243be5-bd27-4f37-ba8b-9f6f55f8b3e4 (view SPL)CEFDINIR FOR ORAL SUSPENSIONprescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel2009-12-161548685768, 548685769
13e49b6477-4c64-41a5-b3a3-37461757a6fd (view SPL)prescriptionHuman PrescriptionNorthstar Rx LlcANALYSIS, API MANUFACTURE, MANUFACTURE2013-02-081167140392, 167140393
14ee96536a-cd94-45aa-a5bb-60425b557be7 (view SPL)CEFDINIR FOR ORAL SUSPENSION, USP Rx OnlyprescriptionHuman PrescriptionClinical Solutions WholesaleRELABEL2013-11-251581189974

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