Bisoprolol / Hydrochlorothiazide Oral Tablet

Brand(s)
Ziac
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Teva Women'S Health, Inc. (2011-03-30)
Oldest Current Product
1993-03-26
License(s)
NDA, ANDA
RxNORM
ORAL TABLET\BISOPROLOL:HYDROCHLOROTHIAZIDE
FDAOB
ORAL\TABLET\BISOPROLOL FUMARATE: HYDROCHLOROTHIAZIDE
SPL Active
ORAL\TABLET, COATED\BISOPROLOL FUMARATE: HYDROCHLOROTHIAZIDE
ORAL\TABLET, FILM COATED\BISOPROLOL FUMARATE: HYDROCHLOROTHIAZIDE
ORAL\TABLET\BISOPROLOL FUMARATE: HYDROCHLOROTHIAZIDE
SPL Moiety
ORAL\TABLET, COATED\BISOPROLOL: HYDROCHLOROTHIAZIDE
ORAL\TABLET, FILM COATED\BISOPROLOL: HYDROCHLOROTHIAZIDE
ORAL\TABLET\BISOPROLOL: HYDROCHLOROTHIAZIDE

product(s) by strength(s)

bisoprolol fumarate 10 mg / hydrochlorothiazide 6.25 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1512850040ZiacNDATeva Women'S Health, Inc.1993-03-26BISOPROLOL FUMARATE, HYDROCHLOROTHIAZIDEORALTABLET, FILM COATEDNDA020186238176e5-df10-457b-a5cf-c950a583e748

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001850707ANDAEon Labs, Inc.2000-09-25BISOPROLOL FUMARATE, HYDROCHLOROTHIAZIDEORALTABLET, COATEDANDA0755793bc17845-11ff-48b5-9a29-4b349df04f6f
2003780505ANDAMylan Pharmaceuticals Inc.2000-09-25BISOPROLOL FUMARATE, HYDROCHLOROTHIAZIDEORALTABLET, FILM COATEDANDA075768d4243a76-516c-417e-80ba-444a21ecc688

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1105440174ANDABlenheim Pharmacal, Inc.2013-11-15BISOPROLOL FUMARATE, HYDROCHLOROTHIAZIDEORALTABLET293000189ANDA0791067e310381-d7dd-410f-9064-31bcea2dcc87
2216950809ANDARebel Distributors Corp2000-09-25BISOPROLOL FUMARATE, HYDROCHLOROTHIAZIDEORALTABLET, COATED001850707ANDA0755794ae433f5-52bb-4403-984c-32f0fad50dd1
3430630134ANDAPd-Rx Pharmaceuticals, Inc.2011-10-03BISOPROLOL FUMARATE, HYDROCHLOROTHIAZIDEORALTABLET, FILM COATED003780505ANDA075768b0d3df23-9450-4ae8-b626-d14d8b9ef481
4548684578ANDAPhysicians Total Care, Inc.2003-08-01BISOPROLOL FUMARATE, HYDROCHLOROTHIAZIDEORALTABLET, COATED001850707ANDA075579ec524b62-3b42-4c36-bca6-7ef442fcd477
5636293226ANDABryant Ranch Prepack2011-10-03BISOPROLOL FUMARATE, HYDROCHLOROTHIAZIDEORALTABLET, FILM COATED003780505ANDA075768cc2b4c68-68a7-45fc-b27a-2e15960ee540
6636294075ANDABryant Ranch Prepack2000-09-25BISOPROLOL FUMARATE, HYDROCHLOROTHIAZIDEORALTABLET, COATED001850707ANDA075579ef3a204e-1209-67d8-038b-bfd04f7210a2

bisoprolol fumarate 2.5 mg / hydrochlorothiazide 6.25 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1512850047ZiacNDATeva Women'S Health, Inc.1993-03-26BISOPROLOL FUMARATE, HYDROCHLOROTHIAZIDEORALTABLET, FILM COATEDNDA020186238176e5-df10-457b-a5cf-c950a583e748

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001850701ANDAEon Labs, Inc.2000-09-25BISOPROLOL FUMARATE, HYDROCHLOROTHIAZIDEORALTABLET, COATEDANDA0755793bc17845-11ff-48b5-9a29-4b349df04f6f
2003780501ANDAMylan Pharmaceuticals Inc.2000-09-25BISOPROLOL FUMARATE, HYDROCHLOROTHIAZIDEORALTABLET, FILM COATEDANDA075768d4243a76-516c-417e-80ba-444a21ecc688
3293000187ANDAUnichem Pharmaceuticals (Usa), Inc.2010-10-12BISOPROLOL FUMARATE, HYDROCHLOROTHIAZIDEORALTABLETANDA079106b9ee689a-ea12-435d-b01c-70d45891e62f

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1105440173ANDABlenheim Pharmacal, Inc.2013-11-15BISOPROLOL FUMARATE, HYDROCHLOROTHIAZIDEORALTABLET293000187ANDA0791067e310381-d7dd-410f-9064-31bcea2dcc87
2548684577ANDAPhysicians Total Care, Inc.2003-06-12BISOPROLOL FUMARATE, HYDROCHLOROTHIAZIDEORALTABLET, COATED001850701ANDA075579ec524b62-3b42-4c36-bca6-7ef442fcd477
3636291674ANDABryant Ranch Prepack2000-09-25BISOPROLOL FUMARATE, HYDROCHLOROTHIAZIDEORALTABLET, COATED001850701ANDA0755790bbd736b-7a81-446e-a2e8-796f5c540cda

bisoprolol fumarate 5 mg / hydrochlorothiazide 6.25 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1512850050ZiacNDATeva Women'S Health, Inc.1993-03-26BISOPROLOL FUMARATE, HYDROCHLOROTHIAZIDEORALTABLET, FILM COATEDNDA020186238176e5-df10-457b-a5cf-c950a583e748

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001850704ANDAEon Labs, Inc.2000-09-25BISOPROLOL FUMARATE, HYDROCHLOROTHIAZIDEORALTABLET, COATEDANDA0755793bc17845-11ff-48b5-9a29-4b349df04f6f
2003780503ANDAMylan Pharmaceuticals Inc.2000-09-25BISOPROLOL FUMARATE, HYDROCHLOROTHIAZIDEORALTABLET, FILM COATEDANDA075768d4243a76-516c-417e-80ba-444a21ecc688

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1105440563ANDABlenheim Pharmacal, Inc.2013-11-15BISOPROLOL FUMARATE, HYDROCHLOROTHIAZIDEORALTABLET293000188ANDA0791067e310381-d7dd-410f-9064-31bcea2dcc87
2216950808ANDARebel Distributors Corp2000-09-25BISOPROLOL FUMARATE, HYDROCHLOROTHIAZIDEORALTABLET, COATED001850704ANDA0755794ae433f5-52bb-4403-984c-32f0fad50dd1
3332610918ANDAAidarex Pharmaceuticals Llc2010-10-12BISOPROLOL FUMARATE, HYDROCHLOROTHIAZIDEORALTABLET293000188ANDA079106b3afd73f-4640-4a73-aed1-66c46fe533dd
4548684576ANDAPhysicians Total Care, Inc.2002-01-15BISOPROLOL FUMARATE, HYDROCHLOROTHIAZIDEORALTABLET, COATED001850704ANDA075579ec524b62-3b42-4c36-bca6-7ef442fcd477
5636294072ANDABryant Ranch Prepack2000-09-25BISOPROLOL FUMARATE, HYDROCHLOROTHIAZIDEORALTABLET, COATED001850704ANDA075579ec0a685b-c389-433c-83ab-bbbbd23f8a02

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA075469BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDETrueWATSON LABORATORIES INC2000-09-25ANDA075469_001, ANDA075469_002, ANDA075469_003
2ANDA075527BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDETrueSANDOZ INC2000-09-25ANDA075527_001, ANDA075527_002, ANDA075527_003
3ANDA075579BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDESANDOZ INC2000-09-25ANDA075579_001, ANDA075579_002, ANDA075579_003
4ANDA075632BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDETrueIVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA2000-09-27ANDA075632_001, ANDA075632_002, ANDA075632_003
5ANDA075642BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDETrueAPOTHECON INC DIV BRISTOL MYERS SQUIBB2000-12-27ANDA075642_001, ANDA075642_002, ANDA075642_003
6ANDA075672BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDETrueACTAVIS ELIZABETH LLC2000-09-25ANDA075672_001, ANDA075672_002, ANDA075672_003
7ANDA075686BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDETrueTEVA PHARMACEUTICALS USA INC2001-01-19ANDA075686_001, ANDA075686_002, ANDA075686_003
8ANDA075768BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDEMYLAN PHARMACEUTICALS INC2000-09-25ANDA075768_001, ANDA075768_002, ANDA075768_003
9ANDA079106BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDEUNICHEM LABORATORIES LTD2010-07-28ANDA079106_001, ANDA079106_002, ANDA079106_003
10NDA020186ZIACTEVA WOMENS HEALTH INC1993-03-26NDA020186_001, NDA020186_002, NDA020186_003

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA075469_001discontinuedBISOPROLOL FUMARATE (2.5MG), HYDROCHLOROTHIAZIDE (6.25MG)ORALTABLETFalse2000-09-25BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE
2ANDA075469_002discontinuedHYDROCHLOROTHIAZIDE (6.25MG), BISOPROLOL FUMARATE (5MG)ORALTABLETFalse2000-09-25BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE
3ANDA075469_003discontinuedBISOPROLOL FUMARATE (10MG), HYDROCHLOROTHIAZIDE (6.25MG)ORALTABLETFalse2000-09-25BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE
4ANDA075527_001discontinuedBISOPROLOL FUMARATE (2.5MG), HYDROCHLOROTHIAZIDE (6.25MG)ORALTABLETFalse2000-09-25BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE
5ANDA075527_002discontinuedBISOPROLOL FUMARATE (10MG), HYDROCHLOROTHIAZIDE (6.25MG)ORALTABLETFalse2000-09-25BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE
6ANDA075527_003discontinuedHYDROCHLOROTHIAZIDE (6.25MG), BISOPROLOL FUMARATE (5MG)ORALTABLETFalse2000-09-25BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE
7ANDA075579_001RXBISOPROLOL FUMARATE (2.5MG), HYDROCHLOROTHIAZIDE (6.25MG)ORALTABLETFalseAB2000-09-25BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE
8ANDA075579_002RXHYDROCHLOROTHIAZIDE (6.25MG), BISOPROLOL FUMARATE (5MG)ORALTABLETFalseAB2000-09-25BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE
9ANDA075579_003RXBISOPROLOL FUMARATE (10MG), HYDROCHLOROTHIAZIDE (6.25MG)ORALTABLETFalseAB2000-09-25BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE
10ANDA075632_001discontinuedHYDROCHLOROTHIAZIDE (6.25MG), BISOPROLOL FUMARATE (2.5MG)ORALTABLETFalse2000-09-27BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE
11ANDA075632_002discontinuedBISOPROLOL FUMARATE (5MG), HYDROCHLOROTHIAZIDE (6.25MG)ORALTABLETFalse2000-09-27BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE
12ANDA075632_003discontinuedBISOPROLOL FUMARATE (10MG), HYDROCHLOROTHIAZIDE (6.25MG)ORALTABLETFalse2000-09-27BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE
13ANDA075642_001discontinuedBISOPROLOL FUMARATE (5MG), HYDROCHLOROTHIAZIDE (6.25MG)ORALTABLETFalse2000-12-27BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE
14ANDA075642_002discontinuedHYDROCHLOROTHIAZIDE (6.25MG), BISOPROLOL FUMARATE (2.5MG)ORALTABLETFalse2000-12-27BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE
15ANDA075642_003discontinuedHYDROCHLOROTHIAZIDE (6.25MG), BISOPROLOL FUMARATE (10MG)ORALTABLETFalse2000-12-27BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE
16ANDA075672_001discontinuedBISOPROLOL FUMARATE (2.5MG), HYDROCHLOROTHIAZIDE (6.25MG)ORALTABLETFalse2000-09-25BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE
17ANDA075672_002discontinuedHYDROCHLOROTHIAZIDE (6.25MG), BISOPROLOL FUMARATE (5MG)ORALTABLETFalse2000-09-25BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE
18ANDA075672_003discontinuedBISOPROLOL FUMARATE (10MG), HYDROCHLOROTHIAZIDE (6.25MG)ORALTABLETFalse2000-09-25BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE
19ANDA075686_001discontinuedBISOPROLOL FUMARATE (2.5MG), HYDROCHLOROTHIAZIDE (6.25MG)ORALTABLETFalse2001-01-19BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE
20ANDA075686_002discontinuedHYDROCHLOROTHIAZIDE (6.25MG), BISOPROLOL FUMARATE (5MG)ORALTABLETFalse2001-01-19BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE
21ANDA075686_003discontinuedHYDROCHLOROTHIAZIDE (6.25MG), BISOPROLOL FUMARATE (10MG)ORALTABLETFalse2001-01-19BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE
22ANDA075768_001RXHYDROCHLOROTHIAZIDE (6.25MG), BISOPROLOL FUMARATE (2.5MG)ORALTABLETFalseAB2000-09-25BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE
23ANDA075768_002RXBISOPROLOL FUMARATE (5MG), HYDROCHLOROTHIAZIDE (6.25MG)ORALTABLETFalseAB2000-09-25BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE
24ANDA075768_003RXHYDROCHLOROTHIAZIDE (6.25MG), BISOPROLOL FUMARATE (10MG)ORALTABLETFalseAB2000-09-25BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE
25ANDA079106_001RXHYDROCHLOROTHIAZIDE (6.25MG), BISOPROLOL FUMARATE (2.5MG)ORALTABLETFalseAB2010-07-28BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE
26ANDA079106_002RXBISOPROLOL FUMARATE (5MG), HYDROCHLOROTHIAZIDE (6.25MG)ORALTABLETFalseAB2010-07-28BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE
27ANDA079106_003RXBISOPROLOL FUMARATE (10MG), HYDROCHLOROTHIAZIDE (6.25MG)ORALTABLETFalseAB2010-07-28BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE
28NDA020186_001RXHYDROCHLOROTHIAZIDE (6.25MG), BISOPROLOL FUMARATE (5MG)ORALTABLETFalseAB1993-03-26ZIAC
29NDA020186_002RXBISOPROLOL FUMARATE (10MG), HYDROCHLOROTHIAZIDE (6.25MG)ORALTABLETTrueAB1993-03-26ZIAC
30NDA020186_003RXBISOPROLOL FUMARATE (2.5MG), HYDROCHLOROTHIAZIDE (6.25MG)ORALTABLETFalseAB1993-03-26ZIAC

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
10bbd736b-7a81-446e-a2e8-796f5c540cda (view SPL)Bisoprolol Fumarate and Hydrochlorothiazide TabletsprescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2013-01-181000636291674
2238176e5-df10-457b-a5cf-c950a583e748 (view SPL)ZIAC (Bisoprolol Fumarate and Hydrochlorothiazide) TabletsprescriptionHuman PrescriptionTeva Women'S Health, Inc.2011-03-306512850040, 512850047, 512850050
33bc17845-11ff-48b5-9a29-4b349df04f6f (view SPL)Bisoprolol Fumarate and Hydrochlorothiazide TabletsprescriptionHuman PrescriptionEon Labs, Inc.2011-12-2019001850701, 001850704, 001850707
44ae433f5-52bb-4403-984c-32f0fad50dd1 (view SPL)Bisoprolol Fumarate and Hydrochlorothiazide Tablets, 2.5 mg/6.25 mg, 5 mg/6.25 mg and 10 mg/6.25 mgprescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2010-12-101216950808, 216950809
57e310381-d7dd-410f-9064-31bcea2dcc87 (view SPL)Bisoprolol Fumarate and Hydrochlorothiazide Tablets USPprescriptionHuman PrescriptionBlenheim Pharmacal, Inc.RELABEL, REPACK2015-02-121105440173, 105440174, 105440563
6b0d3df23-9450-4ae8-b626-d14d8b9ef481 (view SPL)prescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2011-09-013430630134
7b3afd73f-4640-4a73-aed1-66c46fe533dd (view SPL)Bisoprolol Fumarate and Hydrochlorothiazide Tablets USPprescriptionHuman PrescriptionAidarex Pharmaceuticals Llc2013-12-142332610918
8b9ee689a-ea12-435d-b01c-70d45891e62f (view SPL)Bisoprolol Fumarate and Hydrochlorothiazide Tablets USPprescriptionHuman PrescriptionUnichem Pharmaceuticals (Usa), Inc.2011-09-094293000187
9cc2b4c68-68a7-45fc-b27a-2e15960ee540 (view SPL)prescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2013-05-171000636293226
10d4243a76-516c-417e-80ba-444a21ecc688 (view SPL)prescriptionHuman PrescriptionMylan Pharmaceuticals Inc.2011-09-014003780501, 003780503, 003780505
11ec0a685b-c389-433c-83ab-bbbbd23f8a02 (view SPL)Bisoprolol Fumarate and Hydrochlorothiazide TabletsprescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2013-01-171000636294072
12ec524b62-3b42-4c36-bca6-7ef442fcd477 (view SPL)Bisoprolol Fumarate and Hydrochlorothiazide TabletsprescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2011-12-152548684576, 548684577, 548684578
13ef3a204e-1209-67d8-038b-bfd04f7210a2 (view SPL)Bisoprolol Fumarate and Hydrochlorothiazide TabletsprescriptionHuman PrescriptionBryant Ranch PrepackMANUFACTURE, RELABEL, REPACK2012-10-122636294075

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