capecitabine Oral Tablet

Brand(s)
Xeloda
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Genentech, Inc. (2015-03-25)
Oldest Current Product
1998-04-30
License(s)
NDA, ANDA
RxNORM
ORAL TABLET\CAPECITABINE
FDAOB
ORAL\TABLET\CAPECITABINE
SPL Active
ORAL\TABLET, FILM COATED\CAPECITABINE
SPL Moiety
ORAL\TABLET, FILM COATED\CAPECITABINE

product(s) by strength(s)

capecitabine 150 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000041100XelodaNDAGenentech, Inc.1998-04-30CAPECITABINEORALTABLET, FILM COATEDNDA020896a1de8bba-3b1d-4c9d-ab8a-32d2c05e67c8

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000937473ANDATeva Pharmaceuticals Usa Inc2014-03-07CAPECITABINEORALTABLET, FILM COATEDANDA0916495753679a-506c-4ac4-b8b2-b27c664d1d40
2003782511ANDAMylan Pharmaceuticals Inc.2014-08-08CAPECITABINEORALTABLET, FILM COATEDANDA09094303dd3301-e9ce-40af-84e1-7b70fc6557b0
3167140467ANDANorthstar Rx Llc2015-11-01CAPECITABINEORALTABLET, FILM COATEDANDA2025937b260da3-dee2-4bbb-9235-39b16720d578
4167290072ANDAAccord Healthcare Inc.2015-06-09CAPECITABINEORALTABLET, FILM COATEDANDA2025938345d55e-ad02-4726-a04b-1a46e3337a4b

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1422910190ANDAAvkare, Inc.2015-03-20CAPECITABINEORALTABLET, FILM COATED000937473ANDA091649b2c7b4ba-831c-a80f-3078-145017268657
2548684143XelodaNDAPhysicians Total Care, Inc.2005-02-20CAPECITABINEORALTABLET, FILM COATED000041100NDA0208966b76b5bb-1d69-43f9-99c6-f39a0b6d8a26

capecitabine 500 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000041101XelodaNDAGenentech, Inc.1998-04-30CAPECITABINEORALTABLET, FILM COATEDNDA020896a1de8bba-3b1d-4c9d-ab8a-32d2c05e67c8

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000937474ANDATeva Pharmaceuticals Usa Inc2014-03-07CAPECITABINEORALTABLET, FILM COATEDANDA0916495753679a-506c-4ac4-b8b2-b27c664d1d40
2003782512ANDAMylan Pharmaceuticals Inc.2014-08-08CAPECITABINEORALTABLET, FILM COATEDANDA09094303dd3301-e9ce-40af-84e1-7b70fc6557b0
3167140468ANDANorthstar Rx Llc2015-11-01CAPECITABINEORALTABLET, FILM COATEDANDA2025937b260da3-dee2-4bbb-9235-39b16720d578
4167290073ANDAAccord Healthcare Inc.2015-05-20CAPECITABINEORALTABLET, FILM COATEDANDA2025938345d55e-ad02-4726-a04b-1a46e3337a4b

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1001790149ANDAKaiser Foundations Hospitals2014-05-14CAPECITABINEORALTABLET, FILM COATED000937474ANDA091649715ef37e-e700-4009-89ca-f5018c480c63
2422910191ANDAAvkare, Inc.2015-03-20CAPECITABINEORALTABLET, FILM COATED000937474ANDA091649b2c7b4ba-831c-a80f-3078-145017268657
3510790510ANDAMylan Institutional Inc.2014-08-23CAPECITABINEORALTABLET, FILM COATED003782512ANDA09094316145a4c-a3d0-404b-bd58-3f220a45ef73
4538080411XelodaNDAState Of Florida Doh Central Pharmacy2009-07-01CAPECITABINEORALTABLET, FILM COATED000041101NDA020896a732b303-9bbd-42ba-a7c5-61c21629ba93
5548685260XelodaNDAPhysicians Total Care, Inc.2005-06-28CAPECITABINEORALTABLET, FILM COATED000041101NDA0208966b76b5bb-1d69-43f9-99c6-f39a0b6d8a26
6606870149ANDAAmerican Health Packaging2015-10-01CAPECITABINEORALTABLET, FILM COATED000937474ANDA0916492777b481-7d7f-461a-b5e0-c09ce2990c34

application(s)

#idtitleapplicantapprovedexclusivityapproved drug
1ANDA090943CAPECITABINEMYLAN PHARMACEUTICALS INC2014-08-08ANDA090943_001, ANDA090943_002
2ANDA091649CAPECITABINETEVA PHARMACEUTICALS USA INC2013-09-16ANDA091649_001, ANDA091649_002
3ANDA202593CAPECITABINEACCORD HEALTHCARE INC2015-04-23ANDA202593_001, ANDA202593_002
4NDA020896XELODAHOFFMANN LA ROCHE INC1998-04-30PEDIATRIC EXCLUSIVITY [2017-06-10]
INFORMATION FROM STUDIES CONDUCTED IN PEDIATRIC PATIENTS WITH NEWLY DIAGNOSED NON-DISSEMINATED DIFFUSED INTRINSIC BRAINSTEM GLIOMAS [2016-12-10]
NDA020896_001, NDA020896_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA090943_001RXCAPECITABINE (150MG)ORALTABLETFalseAB2014-08-08CAPECITABINE
2ANDA090943_002RXCAPECITABINE (500MG)ORALTABLETFalseAB2014-08-08CAPECITABINE
3ANDA091649_001RXCAPECITABINE (150MG)ORALTABLETFalseAB2013-09-16CAPECITABINE
4ANDA091649_002RXCAPECITABINE (500MG)ORALTABLETFalseAB2013-09-16CAPECITABINE
5ANDA202593_001RXCAPECITABINE (150MG)ORALTABLETFalseAB2015-04-23CAPECITABINE
6ANDA202593_002RXCAPECITABINE (500MG)ORALTABLETFalseAB2015-04-23CAPECITABINE
7NDA020896_001RXCAPECITABINE (150MG)ORALTABLETFalseAB1998-04-30XELODA
8NDA020896_002RXCAPECITABINE (500MG)ORALTABLETTrueAB1998-04-30XELODA

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
103dd3301-e9ce-40af-84e1-7b70fc6557b0 (view SPL)These highlights do not include all the information needed to use capecitabine tablets safely and effectively. See full prescribing information for capecitabine tablets.CAPECITABINE tablets, USP film coated for oral use Initial U.S. Approval: 1998prescriptionHuman PrescriptionMylan Pharmaceuticals Inc.2015-04-206003782511, 003782512
216145a4c-a3d0-404b-bd58-3f220a45ef73 (view SPL)These highlights do not include all the information needed to use capecitabine tablets safely and effectively. See full prescribing information for capecitabine tablets.CAPECITABINE tablets, USP Film Coated for Oral use Initial U.S. Approval: 1998prescriptionHuman PrescriptionMylan Institutional Inc.2014-06-061510790510
32777b481-7d7f-461a-b5e0-c09ce2990c34 (view SPL)These highlights do not include all the information needed to use capecitabine tablets USP safely and effectively. See full prescribing information for capecitabine tablets USP. CAPECITABINE tablets USP, for oral useInitial U.S. Approval: 1998prescriptionHuman PrescriptionAmerican Health PackagingREPACK2015-09-171606870149
45753679a-506c-4ac4-b8b2-b27c664d1d40 (view SPL)These highlights do not include all the information needed to use capecitabine tablets USP safely and effectively. See full prescribing information for capecitabine tablets USP. CAPECITABINE tablets, for oral useInitial U.S. Approval: 1998prescriptionHuman PrescriptionTeva Pharmaceuticals Usa Inc2015-06-194000937473, 000937474
56b76b5bb-1d69-43f9-99c6-f39a0b6d8a26 (view SPL)These highlights do not include all the information needed to use XELODA safely and effectively. See full prescribing information for XELODA. XELODA (capecitabine) Tablets, Film Coated for Oral use Initial U.S. Approval: 1998prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2012-06-073548684143, 548685260
6715ef37e-e700-4009-89ca-f5018c480c63 (view SPL)These highlights do not include all the information needed to use capecitabine tablets USP safely and effectively. See full prescribing information for capecitabine tablets USP. Capecitabine Tablets USP, Film-Coated for Oral useInitial U.S. Approval: 1998prescriptionHuman PrescriptionKaiser Foundations Hospitalsrepack2014-05-192001790149
77b260da3-dee2-4bbb-9235-39b16720d578 (view SPL)These highlights do not include all the information needed to use capecitabine tablets safely and effectively. See full prescribing information for capecitabine tablets. CAPECITABINE tablets USP, for oral use Initial U.S. Approval: 1998prescriptionHuman PrescriptionNorthstar Rx Llcanalysis, manufacture2015-10-081167140467, 167140468
88345d55e-ad02-4726-a04b-1a46e3337a4b (view SPL)These highlights do not include all the information needed to use capecitabine tablets safely and effectively. See full prescribing information for capecitabine tablets. CAPECITABINE tablets USP, for oral use Initial U.S. Approval: 1998prescriptionHuman PrescriptionAccord Healthcare Inc.analysis, manufacture2015-05-213167290072, 167290073
9a1de8bba-3b1d-4c9d-ab8a-32d2c05e67c8 (view SPL)These highlights do not include all the information needed to use XELODA safely and effectively. See full prescribing information for XELODA. XELODA (capecitabine) tablets, for oral use Initial U.S. Approval: 1998prescriptionHuman PrescriptionGenentech, Inc.ANALYSIS, API MANUFACTURE, LABEL, MANUFACTURE, PACK2015-03-2512000041100, 000041101
10a732b303-9bbd-42ba-a7c5-61c21629ba93 (view SPL)XELODA (capecitabine) TABLETSprescriptionHuman PrescriptionState Of Florida Doh Central Pharmacyrepack2010-05-201538080411
11b2c7b4ba-831c-a80f-3078-145017268657 (view SPL)These highlights do not include all the information needed to use capecitabine tablets USP safely and effectively. See full prescribing information for capecitabine tablets USP. CAPECITABINE tablets USP, for oral useInitial U.S. Approval: 1998prescriptionHuman PrescriptionAvkare, Inc.2015-03-201422910190, 422910191

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