Hydrochlorothiazide / Metoprolol Oral Tablet

Brand(s)
Lopressor HCT
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Validus Pharmaceuticals Llc (2012-10-22)
Oldest Current Product
1984-12-31
License(s)
NDA, ANDA
RxNORM
ORAL TABLET\HYDROCHLOROTHIAZIDE:METOPROLOL
FDAOB
ORAL\TABLET\HYDROCHLOROTHIAZIDE: METOPROLOL TARTRATE
SPL Active
ORAL\TABLET\HYDROCHLOROTHIAZIDE: METOPROLOL TARTRATE
SPL Moiety
ORAL\TABLET\HYDROCHLOROTHIAZIDE: METOPROLOL

product(s) by strength(s)

hydrochlorothiazide 25 mg / metoprolol tartrate 100 mg oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003780434ANDAMylan Pharmaceuticals Inc.2004-08-23HYDROCHLOROTHIAZIDE, METOPROLOL TARTRATEORALTABLETANDA076792b6cf0f43-8dc3-4535-b651-daf1f9e0336c
2138110670ANDATrigen Laboratories, Inc.2013-09-17HYDROCHLOROTHIAZIDE, METOPROLOL TARTRATEORALTABLETANDA202870364366b9-79ab-441d-8c90-d8713b5cf377
3167140418ANDANorthstar Rx Llc2013-09-17HYDROCHLOROTHIAZIDE, METOPROLOL TARTRATEORALTABLETANDA2028705571dc11-1c5c-41c1-be20-ed91b7ba5cc8
4623320116ANDAAlembic Pharmaceuticals Inc.2015-10-15HYDROCHLOROTHIAZIDE, METOPROLOL TARTRATEORALTABLETANDA2028702b77f66f-6891-4977-be8f-7955473d2f92
5627560368ANDASun Pharmaceutical Industries Limited2012-01-28HYDROCHLOROTHIAZIDE, METOPROLOL TARTRATEORALTABLETANDA090654faaf13ce-5d8d-4c57-a49f-a7a73daa41a5

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548685524ANDAPhysicians Total Care, Inc.2006-02-07HYDROCHLOROTHIAZIDE, METOPROLOL TARTRATEORALTABLET003780434ANDA07679267a67718-e59f-4988-8bfc-9b4ac103e370

hydrochlorothiazide 25 mg / metoprolol tartrate 50 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1306980460Lopressor HCTNDAValidus Pharmaceuticals Llc1984-12-31HYDROCHLOROTHIAZIDE, METOPROLOL TARTRATEORALTABLETNDA018303d8964894-3cd8-41c1-a844-148d2ef38a88

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003780424ANDAMylan Pharmaceuticals Inc.2004-08-23HYDROCHLOROTHIAZIDE, METOPROLOL TARTRATEORALTABLETANDA076792b6cf0f43-8dc3-4535-b651-daf1f9e0336c
2138110669ANDATrigen Laboratories, Inc.2013-09-17HYDROCHLOROTHIAZIDE, METOPROLOL TARTRATEORALTABLETANDA202870364366b9-79ab-441d-8c90-d8713b5cf377
3167140417ANDANorthstar Rx Llc2013-09-17HYDROCHLOROTHIAZIDE, METOPROLOL TARTRATEORALTABLETANDA2028705571dc11-1c5c-41c1-be20-ed91b7ba5cc8
4623320115ANDAAlembic Pharmaceuticals Inc.2015-10-15HYDROCHLOROTHIAZIDE, METOPROLOL TARTRATEORALTABLETANDA2028702b77f66f-6891-4977-be8f-7955473d2f92
5627560370ANDASun Pharmaceutical Industries Limited2012-01-28HYDROCHLOROTHIAZIDE, METOPROLOL TARTRATEORALTABLETANDA090654faaf13ce-5d8d-4c57-a49f-a7a73daa41a5

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548685400ANDAPhysicians Total Care, Inc.2005-09-01HYDROCHLOROTHIAZIDE, METOPROLOL TARTRATEORALTABLET003780424ANDA07679267a67718-e59f-4988-8bfc-9b4ac103e370

hydrochlorothiazide 50 mg / metoprolol tartrate 100 mg oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003780445ANDAMylan Pharmaceuticals Inc.2004-08-23HYDROCHLOROTHIAZIDE, METOPROLOL TARTRATEORALTABLETANDA076792b6cf0f43-8dc3-4535-b651-daf1f9e0336c
2138110671ANDATrigen Laboratories, Inc.2013-09-17HYDROCHLOROTHIAZIDE, METOPROLOL TARTRATEORALTABLETANDA202870364366b9-79ab-441d-8c90-d8713b5cf377
3167140419ANDANorthstar Rx Llc2013-09-17HYDROCHLOROTHIAZIDE, METOPROLOL TARTRATEORALTABLETANDA2028705571dc11-1c5c-41c1-be20-ed91b7ba5cc8
4623320117ANDAAlembic Pharmaceuticals Inc.2015-10-15HYDROCHLOROTHIAZIDE, METOPROLOL TARTRATEORALTABLETANDA2028702b77f66f-6891-4977-be8f-7955473d2f92
5627560369ANDASun Pharmaceutical Industries Limited2012-01-28HYDROCHLOROTHIAZIDE, METOPROLOL TARTRATEORALTABLETANDA090654faaf13ce-5d8d-4c57-a49f-a7a73daa41a5

application(s)

#idtitleapplicantapprovedapproved drug
1ANDA076792METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDEMYLAN PHARMACEUTICALS2004-08-20ANDA076792_001, ANDA076792_002, ANDA076792_003
2ANDA090654METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDESUN PHARMACEUTICAL INDUSTRIES LTD2012-01-19ANDA090654_001, ANDA090654_002, ANDA090654_003
3ANDA202870METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDEALEMBIC PHARMACEUTICALS LTD2013-11-06ANDA202870_001, ANDA202870_002, ANDA202870_003
4NDA018303LOPRESSOR HCTUS PHARMACEUTICALS HOLDINGS I LLC1984-12-31NDA018303_001, NDA018303_002, NDA018303_003

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA076792_001RXMETOPROLOL TARTRATE (50MG), HYDROCHLOROTHIAZIDE (25MG)ORALTABLETFalseAB2004-08-20METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE
2ANDA076792_002RXHYDROCHLOROTHIAZIDE (25MG), METOPROLOL TARTRATE (100MG)ORALTABLETFalseAB2004-08-20METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE
3ANDA076792_003RXMETOPROLOL TARTRATE (100MG), HYDROCHLOROTHIAZIDE (50MG)ORALTABLETFalseAB2004-08-20METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE
4ANDA090654_001RXHYDROCHLOROTHIAZIDE (25MG), METOPROLOL TARTRATE (50MG)ORALTABLETFalseAB2012-01-19METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE
5ANDA090654_002RXMETOPROLOL TARTRATE (100MG), HYDROCHLOROTHIAZIDE (25MG)ORALTABLETFalseAB2012-01-19METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE
6ANDA090654_003RXMETOPROLOL TARTRATE (100MG), HYDROCHLOROTHIAZIDE (50MG)ORALTABLETFalseAB2012-01-19METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE
7ANDA202870_001RXHYDROCHLOROTHIAZIDE (25MG), METOPROLOL TARTRATE (50MG)ORALTABLETFalseAB2013-11-06METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE
8ANDA202870_002RXMETOPROLOL TARTRATE (100MG), HYDROCHLOROTHIAZIDE (25MG)ORALTABLETFalseAB2013-11-06METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE
9ANDA202870_003RXMETOPROLOL TARTRATE (100MG), HYDROCHLOROTHIAZIDE (50MG)ORALTABLETFalseAB2013-11-06METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE
10NDA018303_001RXHYDROCHLOROTHIAZIDE (25MG), METOPROLOL TARTRATE (50MG)ORALTABLETFalseAB1984-12-31LOPRESSOR HCT
11NDA018303_002RXMETOPROLOL TARTRATE (100MG), HYDROCHLOROTHIAZIDE (25MG)ORALTABLETTrueAB1984-12-31LOPRESSOR HCT
12NDA018303_003discontinuedMETOPROLOL TARTRATE (100MG), HYDROCHLOROTHIAZIDE (50MG)ORALTABLETFalse1984-12-31LOPRESSOR HCT

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
12b77f66f-6891-4977-be8f-7955473d2f92 (view SPL)Metoprolol Tartrate and Hydrochlorothiazide Tablets USP 50 mg/25 mg, 100 mg/25 mg and 100 mg/50 mg Beta Blocker/Diuretic Antihypertensive Rx only Prescribing InformationprescriptionHuman PrescriptionAlembic Pharmaceuticals Inc.MANUFACTURE2015-09-251623320115, 623320116, 623320117
2364366b9-79ab-441d-8c90-d8713b5cf377 (view SPL)Metoprolol Tartrate and Hydrochlorothiazide Tablets USP 50 mg/25 mg, 100 mg/25 mg and 100 mg/50 mg Beta Blocker/Diuretic Antihypertensive Rx only Prescribing InformationprescriptionHuman PrescriptionTrigen Laboratories, Inc.MANUFACTURE2014-09-011138110669, 138110670, 138110671
35571dc11-1c5c-41c1-be20-ed91b7ba5cc8 (view SPL)Metoprolol Tartrate and Hydrochlorothiazide Tablets USP 50 mg/25 mg, 100 mg/25 mg and 100 mg/50 mg Beta Blocker/Diuretic Antihypertensive Rx only Prescribing InformationprescriptionHuman PrescriptionNorthstar Rx LlcMANUFACTURE2013-11-133167140417, 167140418, 167140419
467a67718-e59f-4988-8bfc-9b4ac103e370 (view SPL)prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2011-03-311548685400, 548685524
5b6cf0f43-8dc3-4535-b651-daf1f9e0336c (view SPL)prescriptionHuman PrescriptionMylan Pharmaceuticals Inc.2010-04-145003780424, 003780434, 003780445
6d8964894-3cd8-41c1-a844-148d2ef38a88 (view SPL)Lopressor HCT metoprolol tartrate USP and hydrochlorothiazide USP 50/25 Tablets 100/25 Tablets 100/50 TabletsprescriptionHuman PrescriptionValidus Pharmaceuticals Llcmanufacture2012-10-221306980460
7faaf13ce-5d8d-4c57-a49f-a7a73daa41a5 (view SPL)Metoprolol Tartrate and Hydrochlorothiazide Tablets, USPBeta-Blocker/Diuretic AntihypertensiveprescriptionHuman PrescriptionSun Pharmaceutical Industries LimitedANALYSIS, MANUFACTURE2015-05-063627560368, 627560369, 627560370

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