Bumetanide Oral Tablet

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Eon Labs, Inc. (2011-09-21)
Oldest Current Product
1996-11-21
License(s)
NDA AUTHORIZED GENERIC, ANDA
RxNORM
ORAL TABLET\BUMETANIDE
FDAOB
ORAL\TABLET\BUMETANIDE
SPL Active
ORAL\TABLET\BUMETANIDE
SPL Moiety
ORAL\TABLET\BUMETANIDE

product(s) by strength(s)

bumetanide 0.5 mg oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000934232ANDATeva Pharmaceuticals Usa Inc2007-10-16BUMETANIDEORALTABLETANDA07422504236576-01c4-43a6-ac8a-60e23b5dc692
2001850128ANDAEon Labs, Inc.1996-11-21BUMETANIDEORALTABLETANDA07470005cb961d-ac33-4bcf-b04e-411e496c43c1
3427990119NDA AUTHORIZED GENERICEdenbridge Pharmaceuticals, Llc2015-10-15BUMETANIDEORALTABLETNDA01822532c4372e-54ea-4fc8-b9f8-827fa4c8edd3

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1353560988ANDALake Erie Medical Dba Quality Care Products Llc2007-10-16BUMETANIDEORALTABLET000934232ANDA0742259d1b82df-9e2f-4ac4-99ed-f109228dac52
2422910178ANDAAvkare, Inc.2015-01-26BUMETANIDEORALTABLET000934232ANDA074225509dba6d-7e53-02ed-8d86-fe83a2126250
3548683765ANDAPhysicians Total Care, Inc.2000-11-29BUMETANIDEORALTABLET001850128ANDA074700d91945d7-f626-4ae2-b252-c88a38fc9ca1

bumetanide 1 mg oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000934233ANDATeva Pharmaceuticals Usa Inc2007-10-16BUMETANIDEORALTABLETANDA07422504236576-01c4-43a6-ac8a-60e23b5dc692
2001850129ANDAEon Labs, Inc.1996-11-21BUMETANIDEORALTABLETANDA07470005cb961d-ac33-4bcf-b04e-411e496c43c1
3427990120NDA AUTHORIZED GENERICEdenbridge Pharmaceuticals, Llc2015-10-15BUMETANIDEORALTABLETNDA01822532c4372e-54ea-4fc8-b9f8-827fa4c8edd3

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1006154536ANDANcs Healthcare Of Ky, Inc Dba Vangard Labs2007-10-16BUMETANIDEORALTABLET000934233ANDA074225925b309a-8a0b-4bcd-bdf4-1ec42780ecc2
2332610983ANDAAidarex Pharmaceuticals Llc2007-10-16BUMETANIDEORALTABLET000934233ANDA0742251c4015ba-567a-403c-91f6-fad7749ea2a2
3353560912ANDALake Erie Medical Dba Quality Care Products Llc2007-10-16BUMETANIDEORALTABLET000934233ANDA0742259d1b82df-9e2f-4ac4-99ed-f109228dac52
4422910179ANDAAvkare, Inc.2015-01-26BUMETANIDEORALTABLET000934233ANDA074225509dba6d-7e53-02ed-8d86-fe83a2126250
5504364233ANDAUnit Dose Services2007-10-16BUMETANIDEORALTABLET000934233ANDA074225c386547a-e741-4dee-84f4-f520ea895291
6548683764ANDAPhysicians Total Care, Inc.2009-02-16BUMETANIDEORALTABLET001850129ANDA074700d91945d7-f626-4ae2-b252-c88a38fc9ca1
7551545489ANDACardinal Health2011-04-29BUMETANIDEORALTABLET510790892ANDA074700d788f9e9-105c-497d-8004-ac8ce80aee64
8607600446ANDASt Marys Medical Park Pharmacy2014-05-22BUMETANIDEORALTABLET000934233ANDA074225c2e1f993-434a-4f09-acf0-a3849957d5c5
9636294968ANDABryant Ranch Prepack2007-10-16BUMETANIDEORALTABLET000934233ANDA0742250fb6d547-9966-4352-8974-d02ea58e6445

bumetanide 2 mg oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000934234ANDATeva Pharmaceuticals Usa Inc2007-10-16BUMETANIDEORALTABLETANDA07422504236576-01c4-43a6-ac8a-60e23b5dc692
2001850130ANDAEon Labs, Inc.1996-11-21BUMETANIDEORALTABLETANDA07470005cb961d-ac33-4bcf-b04e-411e496c43c1
3427990121NDA AUTHORIZED GENERICEdenbridge Pharmaceuticals, Llc2015-10-15BUMETANIDEORALTABLETNDA01822532c4372e-54ea-4fc8-b9f8-827fa4c8edd3

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1006155534ANDANcs Healthcare Of Ky, Inc Dba Vangard Labs2007-10-16BUMETANIDEORALTABLET000934234ANDA074225925b309a-8a0b-4bcd-bdf4-1ec42780ecc2
2353560902ANDALake Erie Medical Dba Quality Care Products Llc2007-10-16BUMETANIDEORALTABLET000934234ANDA0742259d1b82df-9e2f-4ac4-99ed-f109228dac52
3422910180ANDAAvkare, Inc.2015-01-26BUMETANIDEORALTABLET000934234ANDA074225509dba6d-7e53-02ed-8d86-fe83a2126250
4504364234ANDAUnit Dose Services2007-10-16BUMETANIDEORALTABLET000934234ANDA074225a3594e64-c819-4b01-a7b2-ddacbda19ada
5548684352ANDAPhysicians Total Care, Inc.2006-12-13BUMETANIDEORALTABLET001850130ANDA074700d91945d7-f626-4ae2-b252-c88a38fc9ca1
6607600447ANDASt Marys Medical Park Pharmacy2014-08-20BUMETANIDEORALTABLET000934234ANDA074225f5e9dc4f-3b0b-4b2e-ace4-abe1d1989768

application(s)

#idtitleapplicantapprovedapproved drug
1ANDA074225BUMETANIDEIVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA1995-04-24ANDA074225_001, ANDA074225_002, ANDA074225_003
2ANDA074700BUMETANIDESANDOZ INC1996-11-21ANDA074700_001, ANDA074700_002, ANDA074700_003
3NDA018225BUMEXVALIDUS PHARMACEUTICALS INC1983-02-28NDA018225_001, NDA018225_002, NDA018225_003

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA074225_001RXBUMETANIDE (0.5MG)ORALTABLETFalseAB1995-04-24BUMETANIDE
2ANDA074225_002RXBUMETANIDE (1MG)ORALTABLETFalseAB1995-04-24BUMETANIDE
3ANDA074225_003RXBUMETANIDE (2MG)ORALTABLETFalseAB1995-04-24BUMETANIDE
4ANDA074700_001RXBUMETANIDE (0.5MG)ORALTABLETFalseAB1996-11-21BUMETANIDE
5ANDA074700_002RXBUMETANIDE (1MG)ORALTABLETFalseAB1996-11-21BUMETANIDE
6ANDA074700_003RXBUMETANIDE (2MG)ORALTABLETTrueAB1996-11-21BUMETANIDE
7NDA018225_001RXBUMETANIDE (1MG)ORALTABLETFalseAB1983-02-28BUMEX
8NDA018225_002RXBUMETANIDE (0.5MG)ORALTABLETFalseAB1983-02-28BUMEX
9NDA018225_003RXBUMETANIDE (2MG)ORALTABLETFalseAB1985-06-14BUMEX

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
104236576-01c4-43a6-ac8a-60e23b5dc692 (view SPL)BUMETANIDE TABLETS USPprescriptionHuman PrescriptionTeva Pharmaceuticals Usa Inc2013-09-056000934232, 000934233, 000934234
205cb961d-ac33-4bcf-b04e-411e496c43c1 (view SPL)Bumetanide Tablets USPprescriptionHuman PrescriptionEon Labs, Inc.2011-09-2114001850128, 001850129, 001850130
30fb6d547-9966-4352-8974-d02ea58e6445 (view SPL)BUMETANIDE TABLETS USPprescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2014-05-231000636294968
41c4015ba-567a-403c-91f6-fad7749ea2a2 (view SPL)BUMETANIDE TABLETS USPprescriptionHuman PrescriptionAidarex Pharmaceuticals Llc2013-12-141332610983
532c4372e-54ea-4fc8-b9f8-827fa4c8edd3 (view SPL)Bumetanide Tablets USPprescriptionHuman PrescriptionEdenbridge Pharmaceuticals, Llc2015-10-161427990119, 427990120, 427990121
6509dba6d-7e53-02ed-8d86-fe83a2126250 (view SPL)BUMETANIDE TABLETS USPprescriptionHuman PrescriptionAvkare, Inc.2015-01-262422910178, 422910179, 422910180
7925b309a-8a0b-4bcd-bdf4-1ec42780ecc2 (view SPL)BUMETANIDE TABLETS USPprescriptionHuman PrescriptionNcs Healthcare Of Ky, Inc Dba Vangard LabsRELABEL, REPACK2012-10-182006154536, 006155534
89d1b82df-9e2f-4ac4-99ed-f109228dac52 (view SPL)BUMETANIDE TABLETS USPprescriptionHuman PrescriptionLake Erie Medical Dba Quality Care Products Llcrepack2013-07-171353560902, 353560912, 353560988
9a3594e64-c819-4b01-a7b2-ddacbda19ada (view SPL)BUMETANIDE TABLETS USPprescriptionHuman PrescriptionUnit Dose ServicesREPACK2012-07-302504364234
10c2e1f993-434a-4f09-acf0-a3849957d5c5 (view SPL)BUMETANIDE TABLETS USPprescriptionHuman PrescriptionSt Marys Medical Park Pharmacymanufacture, relabel, repack2014-05-221607600446
11c386547a-e741-4dee-84f4-f520ea895291 (view SPL)BUMETANIDE TABLETS USPprescriptionHuman PrescriptionUnit Dose ServicesREPACK2012-07-302504364233
12d788f9e9-105c-497d-8004-ac8ce80aee64 (view SPL)Bumetanide Tablets USPprescriptionHuman PrescriptionCardinal HealthREPACK2013-10-168551545489
13d91945d7-f626-4ae2-b252-c88a38fc9ca1 (view SPL)Bumetanide Tablets USPprescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2012-09-134548683764, 548683765, 548684352
14f5e9dc4f-3b0b-4b2e-ace4-abe1d1989768 (view SPL)BUMETANIDE TABLETS USPprescriptionHuman PrescriptionSt Marys Medical Park Pharmacymanufacture, relabel, repack2014-08-201607600447

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