cefdinir Oral Capsule

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 CAPSULE\CEFDINIR
FDAOB
ORAL\CAPSULE\CEFDINIR
SPL Active
ORAL\CAPSULE\CEFDINIR
ORAL\CAPSULE\CEFDINIR MONOHYDRATE
SPL Moiety
ORAL\CAPSULE\CEFDINIR

product(s) by strength(s)

cefdinir 300 mg oral capsule

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000933160ANDATeva Pharmaceuticals Usa Inc2007-05-09CEFDINIRORALCAPSULEANDA065368de3441e3-7fd2-4d29-a8b7-0f9b66e35c9c
2007812176ANDASandoz Inc2007-04-06CEFDINIRORALCAPSULEANDA06533038f6adf7-e26c-4764-8ec9-360813874dd4
3167140391ANDANorthstar Rx Llc2008-01-07CEFDINIRORALCAPSULEANDA065434831f04e4-4566-49f8-9552-2378307a10c8
4420430250ANDAOrchidpharma Inc2014-07-04CEFDINIR MONOHYDRATEORALCAPSULEANDA065418417d5645-ea57-4a07-a21d-31a7132721cd
5572370099ANDACitron Pharma Llc2008-01-07CEFDINIRORALCAPSULEANDA065434a5594006-8e37-459e-8e85-7e2a83d7a57e
6658620177ANDAAurobindo Pharma Limited2008-01-07CEFDINIRORALCAPSULEANDA065434df26edb0-9bd6-449c-a187-0be0c9e2600c
7672530011ANDADava Pharmaceuticals, Inc.2014-05-01CEFDINIRORALCAPSULEANDA065330befe82b9-e822-4917-9774-b4cbd0c66a1e
8680010150ANDABluepoint Laboratories2014-02-07CEFDINIRORALCAPSULEANDA065264a056eb8b-04e8-42fb-a4ff-42f017a113cb
9681800711ANDALupin Pharmaceuticals, Inc.2007-05-01CEFDINIRORALCAPSULEANDA065264cb7366ce-1778-451f-aba5-65cf73c9b87a

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1105440194ANDABlenheim Pharmacal, Inc.2013-11-15CEFDINIRORALCAPSULE658620177ANDA0654341181a59e-a433-20d0-e054-00144ff88e88
2216950620ANDARebel Distributors Corp2008-01-07CEFDINIRORALCAPSULE658620177ANDA065434a84712bf-221d-4366-9cf0-b8c19428c276
3422540177ANDARebel Distributors Corp2011-01-14CEFDINIRORALCAPSULE000933160ANDA065368f910ec1a-3896-45b9-b8b2-df50a50064a1
4430630466ANDAPd-Rx Pharmaceuticals, Inc.2007-05-01CEFDINIRORALCAPSULE681800711ANDA0652646f76b0f7-2b50-4d14-8bec-010597ae2880
5430630597ANDAPd-Rx Pharmaceuticals, Inc.2014-07-04CEFDINIR MONOHYDRATEORALCAPSULE420430250ANDA06541877e061e8-d3e2-4955-9f65-59510b5afc70
6430630603ANDAPd-Rx Pharmaceuticals, Inc.2014-07-04CEFDINIR MONOHYDRATEORALCAPSULE420430250ANDA065418eb3b3440-95f4-450a-af9c-a87aca480bad
7516550019ANDANorthwind Pharmaceuticals, Llc2015-02-10CEFDINIRORALCAPSULE672530011ANDA065330c36c0d83-583b-4448-97a3-00169fcbdf75
8516550214ANDANorthwind Pharmaceuticals, Llc2014-09-17CEFDINIRORALCAPSULE000933160ANDA065368145e4a41-286e-4033-97c4-92d674d7bb89
9529590134ANDAH.J. Harkins Company, Inc.2008-08-23CEFDINIRORALCAPSULE658620177ANDA065434a3262279-1f9e-401b-9b02-6da3ef374b46
10545695921ANDAA-S Medication Solutions Llc2007-05-01CEFDINIRORALCAPSULE681800711ANDA065264c2d25379-bec7-4583-a8bc-8c03cdb893ed
11548685767ANDAPhysicians Total Care, Inc.2007-05-08CEFDINIRORALCAPSULE658620177ANDA065434a78a68a4-5425-43c4-81cc-7733b72445b8
12552890081ANDAPd-Rx Pharmaceuticals, Inc.2011-01-14CEFDINIRORALCAPSULE000933160ANDA065368c3ca8720-8e27-47ed-9829-a42ae9eb885d
13672960469ANDARedpharm Drug Inc.2007-05-01CEFDINIRORALCAPSULE681800711ANDA065264bcf04f49-8d0b-4563-9d0f-93939cdf6a6c
14687889760ANDAPreferred Pharmaceuticals, Inc.2015-08-20CEFDINIR MONOHYDRATEORALCAPSULE420430250ANDA0654181165564d-025e-460d-a1bd-1ca5300ae3fe

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA065264CEFDINIRLUPIN LTD2006-05-19ANDA065264_001
2ANDA065330CEFDINIRSANDOZ INC2007-04-06ANDA065330_001
3ANDA065368CEFDINIRTEVA PHARMACEUTICALS USA2007-05-09ANDA065368_001
4ANDA065418CEFDINIRORCHID HEALTHCARE2007-07-18ANDA065418_001
5ANDA065434CEFDINIRAUROBINDO PHARMA LTD2008-01-07ANDA065434_001
6NDA050739OMNICEFTrueABBVIE INC1997-12-04NDA050739_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA065264_001RXCEFDINIR (300MG)ORALCAPSULEFalseAB2006-05-19CEFDINIR
2ANDA065330_001RXCEFDINIR (300MG)ORALCAPSULETrueAB2007-04-06CEFDINIR
3ANDA065368_001RXCEFDINIR (300MG)ORALCAPSULEFalseAB2007-05-09CEFDINIR
4ANDA065418_001RXCEFDINIR (300MG)ORALCAPSULEFalseAB2007-07-18CEFDINIR
5ANDA065434_001RXCEFDINIR (300MG)ORALCAPSULEFalseAB2008-01-07CEFDINIR
6NDA050739_001discontinuedCEFDINIR (300MG)ORALCAPSULEFalse1997-12-04OMNICEF

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
11165564d-025e-460d-a1bd-1ca5300ae3fe (view SPL)Cefdinir Capsules, USPprescriptionHuman PrescriptionPreferred Pharmaceuticals, Inc.REPACK2015-08-201687889760
21181a59e-a433-20d0-e054-00144ff88e88 (view SPL)Cefdinir Capsules, USP Rx OnlyprescriptionHuman PrescriptionBlenheim Pharmacal, Inc.repack2015-03-171105440194
3145e4a41-286e-4033-97c4-92d674d7bb89 (view SPL)CefdinirprescriptionHuman PrescriptionNorthwind Pharmaceuticals, Llcrepack2014-09-231516550214
438f6adf7-e26c-4764-8ec9-360813874dd4 (view SPL)Cefdinir CapsulesprescriptionHuman PrescriptionSandoz Inc2012-04-1011007812176
5417d5645-ea57-4a07-a21d-31a7132721cd (view SPL)Cefdinir Capsules, USPprescriptionHuman PrescriptionOrchidpharma Incanalysis, label, manufacture, pack2014-07-252420430250
66f76b0f7-2b50-4d14-8bec-010597ae2880 (view SPL)CEFDINIR CAPSULES USPprescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2011-04-013430630466
777e061e8-d3e2-4955-9f65-59510b5afc70 (view SPL)Cefdinir Capsules, USPprescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2014-07-253430630597
8831f04e4-4566-49f8-9552-2378307a10c8 (view SPL)Cefdinir Capsules, USPprescriptionHuman PrescriptionNorthstar Rx LlcANALYSIS, API MANUFACTURE, MANUFACTURE2013-02-081167140391
9a056eb8b-04e8-42fb-a4ff-42f017a113cb (view SPL)CEFDINIR CAPSULES USPprescriptionHuman PrescriptionBluepoint LaboratoriesMANUFACTURE2015-05-132680010150
10a3262279-1f9e-401b-9b02-6da3ef374b46 (view SPL)Cefdinir CapsulesprescriptionHuman PrescriptionH.J. Harkins Company, Inc.MANUFACTURE2011-08-231529590134
11a5594006-8e37-459e-8e85-7e2a83d7a57e (view SPL)Cefdinir Capsules, USPRx OnlyprescriptionHuman PrescriptionCitron Pharma LlcANALYSIS, API MANUFACTURE, MANUFACTURE2014-08-071572370099
12a78a68a4-5425-43c4-81cc-7733b72445b8 (view SPL)Cefdinir CapsulesprescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2010-12-023548685767
13a84712bf-221d-4366-9cf0-b8c19428c276 (view SPL)Cefdinir CapsulesprescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2011-01-171216950620
14bcf04f49-8d0b-4563-9d0f-93939cdf6a6c (view SPL)Cednifir CapsulesprescriptionHuman PrescriptionRedpharm Drug Inc.manufacture2011-07-062672960469
15befe82b9-e822-4917-9774-b4cbd0c66a1e (view SPL)CEFDINIR CAPSULESprescriptionHuman PrescriptionDava Pharmaceuticals, Inc.2014-02-1210672530011
16c2d25379-bec7-4583-a8bc-8c03cdb893ed (view SPL)CEFDINIR CAPSULES USPprescriptionHuman PrescriptionA-S Medication Solutions Llcrepack2013-06-221545695921
17c36c0d83-583b-4448-97a3-00169fcbdf75 (view SPL)CEFDINIRprescriptionHuman PrescriptionNorthwind Pharmaceuticals, Llcrepack2015-03-251516550019
18c3ca8720-8e27-47ed-9829-a42ae9eb885d (view SPL)CEFDINIR CAPSULES3160Rx onlyprescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2011-01-143552890081
19cb7366ce-1778-451f-aba5-65cf73c9b87a (view SPL)CEFDINIR CAPSULES USPprescriptionHuman PrescriptionLupin Pharmaceuticals, Inc.2011-04-011681800711
20de3441e3-7fd2-4d29-a8b7-0f9b66e35c9c (view SPL)CEFDINIR CAPSULES USP3160Rx onlyprescriptionHuman PrescriptionTeva Pharmaceuticals Usa Inc2014-10-026000933160
21df26edb0-9bd6-449c-a187-0be0c9e2600c (view SPL)Cefdinir Capsules, USPRx OnlyprescriptionHuman PrescriptionAurobindo Pharma LimitedANALYSIS, API MANUFACTURE, MANUFACTURE2014-09-059658620177
22eb3b3440-95f4-450a-af9c-a87aca480bad (view SPL)Cefdinir Capsules, USPprescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2014-07-253430630603
23f910ec1a-3896-45b9-b8b2-df50a50064a1 (view SPL)CEFDINIR CAPSULES3160Rx onlyprescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2012-03-201422540177

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