potassium citrate Extended Release Oral Tablet

Brand(s)
Urocit-K
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Mission Pharmacal Company (2010-04-23)
Oldest Current Product
2003-04-17
License(s)
NDA, NDA AUTHORIZED GENERIC, ANDA
RxNORM
EXTENDED RELEASE ORAL TABLET\POTASSIUM CITRATE
FDAOB
ORAL\TABLET, EXTENDED RELEASE\POTASSIUM CITRATE
SPL Active
ORAL\TABLET, EXTENDED RELEASE\POTASSIUM CITRATE
ORAL\TABLET\POTASSIUM CITRATE
SPL Moiety
ORAL\TABLET, EXTENDED RELEASE\ANHYDROUS CITRIC ACID
ORAL\TABLET, EXTENDED RELEASE\POTASSIUM CATION
ORAL\TABLET\ANHYDROUS CITRIC ACID

product(s) by strength(s)

potassium citrate 10 meq extended release oral tablet

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1002450071NDAUpsher-Smith Laboratories, Inc.2006-09-01POTASSIUM CITRATEORALTABLETNDA0190712215dc1d-0b5a-469e-9b51-4d7480a51078

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548684779Urocit-KNDAPhysicians Total Care, Inc.2003-04-17POTASSIUM CITRATEORALTABLET, EXTENDED RELEASE001780610NDA019071d2c923d5-85c1-4bbb-9f93-556080a5ef87
2548685644ANDAPhysicians Total Care, Inc.2006-07-24POTASSIUM CITRATEORALTABLET, EXTENDED RELEASE649800138ANDA07744090b9f6a9-0242-44dc-8514-91650d693e31
3680840850ANDAAmerican Health Packaging2014-10-01POTASSIUM CITRATEORALTABLET, EXTENDED RELEASE683820537ANDA2035461201c777-2388-4235-bb8f-eb7dc1e867f8

potassium citrate 15 meq extended release oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001780615Urocit-KNDAMission Pharmacal Company2010-01-27POTASSIUM CITRATEORALTABLET, EXTENDED RELEASENDA01907172cdea1b-2240-41db-987d-86d5c6aaa978

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1445230415NDA AUTHORIZED GENERICBiocomp Pharma, Inc.2013-12-23POTASSIUM CITRATEORALTABLETNDA019071b32fe71a-4a58-04a1-64d3-bc3cc4a895bf

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548686176Urocit-KNDAPhysicians Total Care, Inc.2010-09-15POTASSIUM CITRATEORALTABLET, EXTENDED RELEASE001780615NDA019071d2c923d5-85c1-4bbb-9f93-556080a5ef87

potassium citrate 5 meq extended release oral tablet

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1002450070NDAUpsher-Smith Laboratories, Inc.2006-09-01POTASSIUM CITRATEORALTABLETNDA0190712215dc1d-0b5a-469e-9b51-4d7480a51078

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1658410536ANDACadila Healthcare Limited2014-08-12POTASSIUM CITRATEORALTABLET, EXTENDED RELEASEANDA20354639f46084-fc4b-4bfc-91cb-9be7e647655a
2683820536ANDAZydus Pharmaceuticals (Usa) Inc.2014-08-12POTASSIUM CITRATEORALTABLET, EXTENDED RELEASEANDA2035461a839f91-9bbd-4f46-b350-c5e8074b5db7

application(s)

#idtitleapplicantapprovedapproved drug
1ANDA077440POTASSIUM CITRATECOREPHARMA LLC2006-06-09ANDA077440_001, ANDA077440_002
2ANDA203546POTASSIUM CITRATEZYDUS PHARMACEUTICALS USA INC2014-08-06ANDA203546_001, ANDA203546_002, ANDA203546_003
3NDA019071UROCIT-KMISSION PHARMACAL CO1985-08-30NDA019071_001, NDA019071_002, NDA019071_003

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA077440_001RXPOTASSIUM CITRATE (5MEQ)ORALTABLET, EXTENDED RELEASEFalseAB2006-06-09POTASSIUM CITRATE
2ANDA077440_002RXPOTASSIUM CITRATE (10MEQ)ORALTABLET, EXTENDED RELEASEFalseAB2006-06-09POTASSIUM CITRATE
3ANDA203546_001RXPOTASSIUM CITRATE (5MEQ)ORALTABLET, EXTENDED RELEASEFalseAB2014-08-06POTASSIUM CITRATE
4ANDA203546_002RXPOTASSIUM CITRATE (10MEQ)ORALTABLET, EXTENDED RELEASEFalseAB2014-08-06POTASSIUM CITRATE
5ANDA203546_003RXPOTASSIUM CITRATE (15MEQ)ORALTABLET, EXTENDED RELEASEFalseAB2014-08-06POTASSIUM CITRATE
6NDA019071_001RXPOTASSIUM CITRATE (5MEQ)ORALTABLET, EXTENDED RELEASEFalseAB1985-08-30UROCIT-K
7NDA019071_002RXPOTASSIUM CITRATE (10MEQ)ORALTABLET, EXTENDED RELEASEFalseAB1992-08-31UROCIT-K
8NDA019071_003RXPOTASSIUM CITRATE (15MEQ)ORALTABLET, EXTENDED RELEASETrueAB2009-12-30UROCIT-K

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
11201c777-2388-4235-bb8f-eb7dc1e867f8 (view SPL)These highlights do not include all the information needed to use Potassium Citrate Extended-release Tablets safely and effectively. See full prescribing information for Potassium Citrate Extended-release Tablets. POTASSIUM citrate extended-release tablets for oral use Initial U.S. Approval: 1985prescriptionHuman PrescriptionAmerican Health PackagingREPACK2015-10-212680840850
21a839f91-9bbd-4f46-b350-c5e8074b5db7 (view SPL)These highlights do not include all the information needed to use Potassium Citrate Extended-release Tablets safely and effectively. See full prescribing information for Potassium Citrate Extended-release Tablets. POTASSIUM citrate extended-release tablets for oral use Initial U.S. Approval: 1985prescriptionHuman PrescriptionZydus Pharmaceuticals (Usa) Inc.Analysis, Manufacture2014-02-261683820536
32215dc1d-0b5a-469e-9b51-4d7480a51078 (view SPL)These highlights do not include all the information needed to use Potassium Citrate Extended-release Tablets safely and effectively. See full prescribing information for Potassium Citrate Extended-release Tablets. Potassium Citrate Extended-release Tablets for oral useInitial U.S. Approval: 1985prescriptionHuman PrescriptionUpsher-Smith Laboratories, Inc.ANALYSIS, MANUFACTURE, RELABEL, REPACK2012-11-293002450070, 002450071
439f46084-fc4b-4bfc-91cb-9be7e647655a (view SPL)These highlights do not include all the information needed to use Potassium Citrate Extended-release Tablets safely and effectively. See full prescribing information for Potassium Citrate Extended-release Tablets. POTASSIUM citrate extended-release tablets for oral use Initial U.S. Approval: 1985prescriptionHuman PrescriptionCadila Healthcare Limited2014-08-111658410536
572cdea1b-2240-41db-987d-86d5c6aaa978 (view SPL)These highlights do not include all the information needed to use Urocit-K safely and effectively. See full prescribing information for Urocit-K. Urocit-K (Potassium Citrate) Extended-release tablets for oral use Initial U.S. Approval: 1985prescriptionHuman PrescriptionMission Pharmacal CompanyMANUFACTURE2010-04-232001780615, 001780600, 001780610
690b9f6a9-0242-44dc-8514-91650d693e31 (view SPL)POTASSIUM CITRATE EXTENDED-RELEASE TABLETS USP5 mEq (540 mg) and 10 mEq (1080 mg)Rx onlyprescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2010-02-181548685644
7b32fe71a-4a58-04a1-64d3-bc3cc4a895bf (view SPL)These highlights do not include all the information needed to use Potassium Citrate safely and effectively. See full prescribing information for Potassium Citrate.Potassium Citrate Extended-release tablets for oral useInitial U.S. Approval: 1985prescriptionHuman PrescriptionBiocomp Pharma, Inc.MANUFACTURE2013-12-181445230415
8d2c923d5-85c1-4bbb-9f93-556080a5ef87 (view SPL)These highlights do not include all the information needed to use Urocit-K safely and effectively. See full prescribing information for Urocit-K. Urocit-K (Potassium Citrate) Extended-release tablets for oral use Initial U.S. Approval: 1985prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2010-04-231548684779, 548686176

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