Cefadroxil Oral Capsule

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Teva Pharmaceuticals Usa Inc (2014-09-22)
Oldest Current Product
1980-07-30
License(s)
ANDA
RxNORM
ORAL CAPSULE\CEFADROXIL
FDAOB
ORAL\CAPSULE\CEFADROXIL/CEFADROXIL HEMIHYDRATE
SPL Active
ORAL\CAPSULE\CEFADROXIL
ORAL\CAPSULE\CEFADROXIL HEMIHYDRATE
SPL Moiety
ORAL\CAPSULE\CEFADROXIL
ORAL\CAPSULE\CEFADROXIL ANHYDROUS
ORAL\CAPSULE\CEFADROXIL: CEFADROXIL ANHYDROUS

product(s) by strength(s)

cefadroxil 500 mg oral capsule

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000933196ANDATeva Pharmaceuticals Usa Inc2007-01-31CEFADROXILORALCAPSULEANDA065282bda86975-8c2f-4c4e-9a4c-a1a959f9336a
2001439947ANDAWest-Ward Pharmaceutical Corp2006-02-07CEFADROXILORALCAPSULEANDA0653113e21c084-bd72-4f5b-87b5-3dadc9db55e8
3007812938ANDASandoz Inc1980-07-30CEFADROXILORALCAPSULEANDA0622910ee42c97-d20c-4ee5-8f25-3a7539bda43b
4167140388ANDANorthstar Rx Llc2007-01-25CEFADROXILORALCAPSULEANDA06535217123057-58c7-401a-b87d-8c4c0764bbf6
5572370096ANDACitron Pharma Llc2007-01-25CEFADROXILORALCAPSULEANDA06535274c99fd8-16d1-4d2c-9158-42ff5eed2b7c
6658620085ANDAAurobindo Pharma Limited2007-01-25CEFADROXILORALCAPSULEANDA0653527bb90096-14d3-400e-94d3-048bff6b1292
7681800180ANDALupin Pharmaceuticals, Inc.2008-04-23CEFADROXILORALCAPSULEANDA0653925fe066ce-2f97-49d7-81bd-a672be1ebecd

invalid application product(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548683742ANDAPhysicians Total Care, Inc.1996-04-23CEFADROXIL HEMIHYDRATEORALCAPSULE633040582ANDA065015a3a7d398-59a7-468b-b05e-fb87e8311b32

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1105440135ANDABlenheim Pharmacal, Inc.2011-07-11CEFADROXILORALCAPSULE681800180ANDA065392615617a6-40b9-46e2-9a3d-169ea5a671de
2165900043ANDAStat Rx Usa Llc2007-01-25CEFADROXILORALCAPSULE658620085ANDA0653528cf65b07-115e-4499-92c4-5f16792a954d
3216950427ANDARebel Distributors Corp2006-02-07CEFADROXILORALCAPSULE001439947ANDA065311b757af04-e516-4ac7-8a2f-45fffab86c5d
4332610018ANDAAidarex Pharmaceuticals Llc2008-04-23CEFADROXILORALCAPSULE681800180ANDA065392d433e4e8-9f38-405e-ac80-bc8dfcba0649
5422540146ANDARebel Distributors Corp2008-04-01CEFADROXILORALCAPSULE681800180ANDA06539242f92a36-4c11-44f6-8f82-716a8b7a3f08
6425490504ANDAStat Rx Usa Llc2007-01-25CEFADROXILORALCAPSULE597622000ANDA065352487193e9-b9ab-443e-a1c5-26aa14cb2641
7430630553ANDAPd-Rx Pharmaceuticals, Inc.2008-04-23CEFADROXILORALCAPSULE681800180ANDA065392f5bbbf87-f059-4bbd-aea9-27d31462654f
8430630595ANDAPd-Rx Pharmaceuticals, Inc.2007-01-25CEFADROXILORALCAPSULE658620085ANDA065352ab9cf28c-7c16-4bfa-879d-c360b4d1d5a6
9529590428ANDAH.J. Harkins Company, Inc.2008-04-01CEFADROXILORALCAPSULE681800180ANDA0653927d49a2f4-c2b9-4127-82df-092da20a35d0
10545694391ANDAA-S Medication Solutions Llc2008-04-23CEFADROXILORALCAPSULE681800180ANDA06539282056bf6-7526-4d0d-9121-cfc19358c789
11552890405ANDAPd-Rx Pharmaceuticals, Inc.2007-01-25CEFADROXILORALCAPSULE597622000ANDA065352783c8a4c-53af-4a58-b3ee-58184d2e9549
12552890589ANDAPd-Rx Pharmaceuticals, Inc.2010-09-21CEFADROXILORALCAPSULE000933196ANDA06528288c7119e-404f-4718-b81f-d77d5eceb8f5
13687880708ANDAPreferred Pharmaceuticals, Inc.2014-10-20CEFADROXILORALCAPSULE681800180ANDA06539272ce2984-4d47-4764-8a92-190a72b9efe4

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA062291CEFADROXILSANDOZ INCANDA062291_001
2ANDA062378ULTRACEFTrueBRISTOL LABORATORIES INC DIV BRISTOL MYERS CO1982-03-16ANDA062378_001
3ANDA062695CEFADROXILTrueTEVA PHARMACEUTICALS USA INC1989-02-10ANDA062695_001
4ANDA062766CEFADROXILTrueIVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA1987-03-03ANDA062766_001
5ANDA063017CEFADROXILTruePUREPAC PHARMACEUTICAL CO1989-01-05ANDA063017_001
6ANDA065015CEFADROXILTrueRANBAXY LABORATORIES LTD1999-06-22ANDA065015_001
7ANDA065282CEFADROXILTEVA PHARMACEUTICALS USA2006-01-20ANDA065282_001
8ANDA065309CEFADROXILORCHID HEALTHCARE2006-09-18ANDA065309_001
9ANDA065311CEFADROXILHIKMA PHARMACEUTICALS2006-02-07ANDA065311_001
10ANDA065352CEFADROXILAUROBINDO PHARMA LTD2007-01-25ANDA065352_001
11ANDA065392CEFADROXILLUPIN LTD2007-05-29ANDA065392_001
12NDA050512DURICEFTrueWARNER CHILCOTT INCNDA050512_001, NDA050512_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA062291_001RXCEFADROXIL/CEFADROXIL HEMIHYDRATE (EQ 500MG BASE)ORALCAPSULEFalseABCEFADROXIL
2ANDA062378_001discontinuedCEFADROXIL/CEFADROXIL HEMIHYDRATE (EQ 500MG BASE)ORALCAPSULEFalse1982-03-16ULTRACEF
3ANDA062695_001discontinuedCEFADROXIL/CEFADROXIL HEMIHYDRATE (EQ 500MG BASE)ORALCAPSULEFalse1989-02-10CEFADROXIL
4ANDA062766_001discontinuedCEFADROXIL/CEFADROXIL HEMIHYDRATE (EQ 500MG BASE)ORALCAPSULEFalse1987-03-03CEFADROXIL
5ANDA063017_001discontinuedCEFADROXIL/CEFADROXIL HEMIHYDRATE (EQ 500MG BASE)ORALCAPSULEFalse1989-01-05CEFADROXIL
6ANDA065015_001discontinuedCEFADROXIL/CEFADROXIL HEMIHYDRATE (EQ 500MG BASE)ORALCAPSULEFalse1999-06-22CEFADROXIL
7ANDA065282_001RXCEFADROXIL/CEFADROXIL HEMIHYDRATE (EQ 500MG BASE)ORALCAPSULETrueAB2006-01-20CEFADROXIL
8ANDA065309_001RXCEFADROXIL/CEFADROXIL HEMIHYDRATE (EQ 500MG BASE)ORALCAPSULEFalseAB2006-09-18CEFADROXIL
9ANDA065311_001RXCEFADROXIL/CEFADROXIL HEMIHYDRATE (EQ 500MG BASE)ORALCAPSULEFalseAB2006-02-07CEFADROXIL
10ANDA065352_001RXCEFADROXIL/CEFADROXIL HEMIHYDRATE (EQ 500MG BASE)ORALCAPSULEFalseAB2007-01-25CEFADROXIL
11ANDA065392_001RXCEFADROXIL/CEFADROXIL HEMIHYDRATE (EQ 500MG BASE)ORALCAPSULEFalseAB2007-05-29CEFADROXIL
12NDA050512_001discontinuedCEFADROXIL/CEFADROXIL HEMIHYDRATE (EQ 500MG BASE)ORALCAPSULEFalseDURICEF
13NDA050512_002discontinuedCEFADROXIL/CEFADROXIL HEMIHYDRATE (EQ 250MG BASE)ORALCAPSULEFalseDURICEF

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
10ee42c97-d20c-4ee5-8f25-3a7539bda43b (view SPL)Cefadroxil Capsules, USPprescriptionHuman PrescriptionSandoz Inc2011-10-1412007812938
217123057-58c7-401a-b87d-8c4c0764bbf6 (view SPL)prescriptionHuman PrescriptionNorthstar Rx LlcANALYSIS, API MANUFACTURE, MANUFACTURE2014-03-202167140388
33e21c084-bd72-4f5b-87b5-3dadc9db55e8 (view SPL)Cefadroxil Capsules and Tablets - MFD by JazeeraprescriptionHuman PrescriptionWest-Ward Pharmaceutical CorpMANUFACTURE2014-03-1311001439947
442f92a36-4c11-44f6-8f82-716a8b7a3f08 (view SPL)Cefadroxil Capsules USP 500 mgprescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2012-03-131422540146
5487193e9-b9ab-443e-a1c5-26aa14cb2641 (view SPL)cefadroxil capsules, USPprescriptionHuman PrescriptionStat Rx Usa Llcrelabel, repack2012-03-301425490504
65fe066ce-2f97-49d7-81bd-a672be1ebecd (view SPL)Cefadroxil Capsules USP 500 mgprescriptionHuman PrescriptionLupin Pharmaceuticals, Inc.2015-01-024681800180
7615617a6-40b9-46e2-9a3d-169ea5a671de (view SPL)Cefadroxil Capsules USP 500 mgprescriptionHuman PrescriptionBlenheim Pharmacal, Inc.repack2015-11-102105440135
872ce2984-4d47-4764-8a92-190a72b9efe4 (view SPL)Cefadroxil Capsules USP 500 mgprescriptionHuman PrescriptionPreferred Pharmaceuticals, Inc.REPACK2014-10-271687880708
974c99fd8-16d1-4d2c-9158-42ff5eed2b7c (view SPL)Cefadroxil Capsules, USPprescriptionHuman PrescriptionCitron Pharma Llc2014-09-061572370096
10783c8a4c-53af-4a58-b3ee-58184d2e9549 (view SPL)cefadroxil capsules, USPprescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2012-01-181552890405
117bb90096-14d3-400e-94d3-048bff6b1292 (view SPL)Cefadroxil Capsules, USPprescriptionHuman PrescriptionAurobindo Pharma LimitedANALYSIS, API MANUFACTURE, MANUFACTURE2014-02-277658620085
127d49a2f4-c2b9-4127-82df-092da20a35d0 (view SPL)Cefadroxil Capsules USP 500 mgprescriptionHuman PrescriptionH.J. Harkins Company, Inc.relabel, repack2012-01-192529590428
1382056bf6-7526-4d0d-9121-cfc19358c789 (view SPL)Cefadroxil Capsules USP 500 mgprescriptionHuman PrescriptionA-S Medication Solutions Llcrepack2013-06-201545694391
1488c7119e-404f-4718-b81f-d77d5eceb8f5 (view SPL)CEFADROXIL CAPSULES USP3196Rx onlyprescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2010-09-213552890589
158cf65b07-115e-4499-92c4-5f16792a954d (view SPL)Cefadroxil Capsules, USPprescriptionHuman PrescriptionStat Rx Usa Llcrelabel, repack2010-08-111165900043
16a3a7d398-59a7-468b-b05e-fb87e8311b32 (view SPL)prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2010-05-111548683742
17ab9cf28c-7c16-4bfa-879d-c360b4d1d5a6 (view SPL)Cefadroxil Capsules, USPprescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2014-02-278430630595
18b757af04-e516-4ac7-8a2f-45fffab86c5d (view SPL)CEFADROXIL CAPSULES USPCEFADROXIL TABLETS USPprescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2011-01-261216950427
19bda86975-8c2f-4c4e-9a4c-a1a959f9336a (view SPL)CEFADROXIL CAPSULES USP3196Rx onlyprescriptionHuman PrescriptionTeva Pharmaceuticals Usa Inc2014-09-228000933196
20d433e4e8-9f38-405e-ac80-bc8dfcba0649 (view SPL)Cefadroxil Capsules USP 500 mgprescriptionHuman PrescriptionAidarex Pharmaceuticals Llc2013-12-161332610018
21f5bbbf87-f059-4bbd-aea9-27d31462654f (view SPL)Cefadroxil Capsules USP 500 mgprescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2012-09-118430630553

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