Metolazone Oral Tablet

Brand(s)
Zaroxolyn
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Upstate Pharma, Llc (2015-06-05)
Oldest Current Product
1973-11-27
License(s)
NDA, NDA AUTHORIZED GENERIC, ANDA
RxNORM
ORAL TABLET\METOLAZONE
FDAOB
ORAL\TABLET\METOLAZONE
SPL Active
ORAL\TABLET\METOLAZONE
SPL Moiety
ORAL\TABLET\METOLAZONE

product(s) by strength(s)

metolazone 10 mg oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001855600ANDAEon Labs, Inc.2003-12-19METOLAZONEORALTABLETANDA0764660b619826-2567-49d7-8972-b6da5e4467df
2003786174ANDAMylan Pharmaceuticals Inc.2004-10-19METOLAZONEORALTABLETANDA0766986639d111-eb21-4997-b964-f5c61bc088f2
3655800645NDA AUTHORIZED GENERICUpstate Pharma, Llc1973-11-27METOLAZONEORALTABLETNDA017386f45f5353-38a3-42c6-bffc-96bea8dcf818

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548685119ANDAPhysicians Total Care, Inc.2004-07-20METOLAZONEORALTABLET001855600ANDA07646678105e5c-5d36-426c-9f79-f2e085460b75
2681512939ANDACarilion Materials Management2004-10-19METOLAZONEORALTABLET003786174ANDA076698e535c22d-ffe7-4adc-b188-9efe4cb580a9

metolazone 2.5 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formapplicationspl
1530140975ZaroxolynNDACelltech Pharmaceuticals, Inc.1973-11-272015-04-30METOLAZONEORALTABLETNDA01738616026409-e821-4680-a114-24c1761d6690

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001855050ANDAEon Labs, Inc.2003-12-19METOLAZONEORALTABLETANDA0767320b619826-2567-49d7-8972-b6da5e4467df
2003786172ANDAMylan Pharmaceuticals Inc.2004-01-06METOLAZONEORALTABLETANDA0766986639d111-eb21-4997-b964-f5c61bc088f2
3655800643NDA AUTHORIZED GENERICUpstate Pharma, Llc1973-11-27METOLAZONEORALTABLETNDA017386f45f5353-38a3-42c6-bffc-96bea8dcf818

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1006156501ANDANcs Healthcare Of Ky, Inc Dba Vangard Labs2003-12-19METOLAZONEORALTABLET001855050ANDA076732e15d3b19-062c-4a0c-b618-008277056853
2006157691ANDANcs Healthcare Of Ky, Inc Dba Vangard Labs2010-01-18METOLAZONEORALTABLET003786172ANDA076698449ebee4-6feb-428b-8cae-9bb0a49d1d3d
3510790023ANDAMylan Institutional Inc.2005-04-15METOLAZONEORALTABLET003786172ANDA076698e5fe856e-7fd6-47fb-87f7-7c1c621f50a0
4548685104ANDAPhysicians Total Care, Inc.2004-07-06METOLAZONEORALTABLET001855050ANDA07673278105e5c-5d36-426c-9f79-f2e085460b75
5551545687ANDACardinal Health2011-01-14METOLAZONEORALTABLET510790023ANDA076698c893c914-6195-45fa-a2bc-4e8b78004737
6681512943ZaroxolynNDACarilion Materials Management1973-11-27METOLAZONEORALTABLET530140975NDA01738658935d94-5bf1-4065-b8b5-ac61292436a7

metolazone 5 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1530140850ZaroxolynNDACelltech Pharmaceuticals, Inc.1973-11-27METOLAZONEORALTABLETNDA01738616026409-e821-4680-a114-24c1761d6690

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001850055ANDAEon Labs, Inc.2003-12-19METOLAZONEORALTABLETANDA0764660b619826-2567-49d7-8972-b6da5e4467df
2003786173ANDAMylan Pharmaceuticals Inc.2004-10-19METOLAZONEORALTABLETANDA0766986639d111-eb21-4997-b964-f5c61bc088f2
3655800644NDA AUTHORIZED GENERICUpstate Pharma, Llc1973-11-27METOLAZONEORALTABLETNDA017386f45f5353-38a3-42c6-bffc-96bea8dcf818

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1006156502ANDANcs Healthcare Of Ky, Inc Dba Vangard Labs2003-12-19METOLAZONEORALTABLET001850055ANDA076732e15d3b19-062c-4a0c-b618-008277056853
2006157692ANDANcs Healthcare Of Ky, Inc Dba Vangard Labs2010-01-18METOLAZONEORALTABLET003786173ANDA076698449ebee4-6feb-428b-8cae-9bb0a49d1d3d
3510790024ANDAMylan Institutional Inc.2005-02-01METOLAZONEORALTABLET003786173ANDA076698e5fe856e-7fd6-47fb-87f7-7c1c621f50a0
4548685056ANDAPhysicians Total Care, Inc.2004-04-27METOLAZONEORALTABLET001850055ANDA07646678105e5c-5d36-426c-9f79-f2e085460b75
5551545688ANDACardinal Health2011-01-14METOLAZONEORALTABLET510790024ANDA076698c893c914-6195-45fa-a2bc-4e8b78004737
6637390404ANDAMckesson Packaging Services A Business Unit Of Mckesson Corporation2006-11-15METOLAZONEORALTABLET001850055ANDA0764664813f476-3637-4f0f-abdd-c76c4074f8ae

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA075543METOLAZONETrueTEVA PHARMACEUTICALS USA INC2003-12-24ANDA075543_003
2ANDA076466METOLAZONESANDOZ INC2003-12-19ANDA076466_001, ANDA076466_002
3ANDA076482METOLAZONETrueROXANE LABORATORIES INC2004-04-29ANDA076482_002
4ANDA076600METOLAZONETrueTEVA PHARMACEUTICALS USA INC2004-01-06ANDA076600_001
5ANDA076698METOLAZONEMYLAN PHARMACEUTICALS INC2003-12-23ANDA076698_001, ANDA076698_002, ANDA076698_003
6ANDA076732METOLAZONESANDOZ INC2003-12-19ANDA076732_001
7ANDA076833METOLAZONETrueTEVA PHARMACEUTICALS USA INC2004-03-01ANDA076833_001
8ANDA076891METOLAZONETrueWATSON LABORATORIES INC2004-07-21ANDA076891_001
9NDA017386ZAROXOLYNUCB INCNDA017386_001, NDA017386_002, NDA017386_003
10NDA018535DIULOTrueGD SEARLE LLCNDA018535_001, NDA018535_002, NDA018535_003
11NDA019532MYKROXTrueUCB INC1987-10-30NDA019532_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA075543_003discontinuedMETOLAZONE (10MG)ORALTABLETFalse2003-12-24METOLAZONE
2ANDA076466_001RXMETOLAZONE (5MG)ORALTABLETFalseAB2003-12-19METOLAZONE
3ANDA076466_002RXMETOLAZONE (10MG)ORALTABLETFalseAB2003-12-19METOLAZONE
4ANDA076482_002discontinuedMETOLAZONE (10MG)ORALTABLETFalse2004-04-29METOLAZONE
5ANDA076600_001discontinuedMETOLAZONE (2.5MG)ORALTABLETFalse2004-01-06METOLAZONE
6ANDA076698_001RXMETOLAZONE (2.5MG)ORALTABLETFalseAB2003-12-23METOLAZONE
7ANDA076698_002RXMETOLAZONE (5MG)ORALTABLETFalseAB2004-10-19METOLAZONE
8ANDA076698_003RXMETOLAZONE (10MG)ORALTABLETFalseAB2004-10-19METOLAZONE
9ANDA076732_001RXMETOLAZONE (2.5MG)ORALTABLETFalseAB2003-12-19METOLAZONE
10ANDA076833_001discontinuedMETOLAZONE (5MG)ORALTABLETFalse2004-03-01METOLAZONE
11ANDA076891_001discontinuedMETOLAZONE (10MG)ORALTABLETFalse2004-07-21METOLAZONE
12NDA017386_001RXMETOLAZONE (2.5MG)ORALTABLETFalseABZAROXOLYN
13NDA017386_002RXMETOLAZONE (5MG)ORALTABLETTrueABZAROXOLYN
14NDA017386_003RXMETOLAZONE (10MG)ORALTABLETTrueABZAROXOLYN
15NDA018535_001discontinuedMETOLAZONE (2.5MG)ORALTABLETFalseDIULO
16NDA018535_002discontinuedMETOLAZONE (5MG)ORALTABLETFalseDIULO
17NDA018535_003discontinuedMETOLAZONE (10MG)ORALTABLETFalseDIULO
18NDA019532_001discontinuedMETOLAZONE (0.5MG)ORALTABLETFalse1987-10-30MYKROX

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
10b619826-2567-49d7-8972-b6da5e4467df (view SPL)Metolazone Tablets USPprescriptionHuman PrescriptionEon Labs, Inc.2011-09-2816001850055, 001855050, 001855600
216026409-e821-4680-a114-24c1761d6690 (view SPL)Zaroxolyn Tablets(metolazone tablets, USP)prescriptionHuman PrescriptionCelltech Pharmaceuticals, Inc.2015-05-067530140850, 530140975
3449ebee4-6feb-428b-8cae-9bb0a49d1d3d (view SPL)Metolazone TabletsprescriptionHuman PrescriptionNcs Healthcare Of Ky, Inc Dba Vangard LabsRELABEL, REPACK2012-05-082006157691, 006157692
44813f476-3637-4f0f-abdd-c76c4074f8ae (view SPL)Metolazone Tablets USPprescriptionHuman PrescriptionMckesson Packaging Services A Business Unit Of Mckesson CorporationREPACK2012-08-311637390404
558935d94-5bf1-4065-b8b5-ac61292436a7 (view SPL)Zaroxolyn Tablets (metolazone tablets, USP)prescriptionHuman PrescriptionCarilion Materials ManagementREPACK2014-02-242681512943
66639d111-eb21-4997-b964-f5c61bc088f2 (view SPL)prescriptionHuman PrescriptionMylan Pharmaceuticals Inc.2004-10-014003786172, 003786173, 003786174
778105e5c-5d36-426c-9f79-f2e085460b75 (view SPL)Metolazone Tablets USPprescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2012-04-242548685056, 548685104, 548685119
8c893c914-6195-45fa-a2bc-4e8b78004737 (view SPL)prescriptionHuman PrescriptionCardinal HealthREPACK2014-10-076551545687, 551545688
9e15d3b19-062c-4a0c-b618-008277056853 (view SPL)Rx onlyprescriptionHuman PrescriptionNcs Healthcare Of Ky, Inc Dba Vangard LabsRELABEL, REPACK2013-07-107006156501, 006156502
10e535c22d-ffe7-4adc-b188-9efe4cb580a9 (view SPL)prescriptionHuman PrescriptionCarilion Materials ManagementREPACK2004-10-012681512939
11e5fe856e-7fd6-47fb-87f7-7c1c621f50a0 (view SPL)prescriptionHuman PrescriptionMylan Institutional Inc.2013-02-012510790023, 510790024
12f45f5353-38a3-42c6-bffc-96bea8dcf818 (view SPL)Metolazone Tablets, USPprescriptionHuman PrescriptionUpstate Pharma, Llc2015-06-053655800643, 655800644, 655800645

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