Fosinopril / Hydrochlorothiazide Oral Tablet

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Heritage Pharmaceuticals Inc. (2014-01-31)
Oldest Current Product
2004-12-20
License(s)
ANDA
RxNORM
ORAL TABLET\FOSINOPRIL:HYDROCHLOROTHIAZIDE
FDAOB
ORAL\TABLET\FOSINOPRIL SODIUM: HYDROCHLOROTHIAZIDE
SPL Active
ORAL\TABLET\FOSINOPRIL SODIUM: HYDROCHLOROTHIAZIDE
SPL Moiety
ORAL\TABLET\FOSINOPRILAT: HYDROCHLOROTHIAZIDE

product(s) by strength(s)

fosinopril sodium 10 mg / hydrochlorothiazide 12.5 mg oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001850341ANDAEon Labs, Inc.2005-09-28FOSINOPRIL SODIUM, HYDROCHLOROTHIAZIDEORALTABLETANDA076961ef0261c6-58be-45ee-8a17-d6e7bbc006ba
2231550060ANDAHeritage Pharmaceuticals Inc.2011-11-15FOSINOPRIL SODIUM, HYDROCHLOROTHIAZIDEORALTABLETANDA0790259921249f-e15d-46e1-b4ad-4d6866f30ca6
3572370026ANDACitron Pharma Llc2009-07-09FOSINOPRIL SODIUM, HYDROCHLOROTHIAZIDEORALTABLETANDA079245978a5492-0c73-42ca-a15b-bba3eb70b41e
4633040403ANDARnabaxy Pharmaceuticals Inc.2004-12-20FOSINOPRIL SODIUM, HYDROCHLOROTHIAZIDEORALTABLETANDA07673952ee65a7-ca1f-48fd-8fad-d72ea0dad4de
5658620308ANDAAurobindo Pharma Limited2009-07-09FOSINOPRIL SODIUM, HYDROCHLOROTHIAZIDEORALTABLETANDA07924535019655-9a30-4305-a262-936ad0e73071
6684620554ANDAGlenmark Generics Inc., Usa2009-07-09FOSINOPRIL SODIUM, HYDROCHLOROTHIAZIDEORALTABLETANDA090228dfa547a8-cb88-47e8-b0a7-ec6cd3950358

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548685346ANDAPhysicians Total Care, Inc.2005-07-06FOSINOPRIL SODIUM, HYDROCHLOROTHIAZIDEORALTABLET68462055401ANDA090228fa2b99f6-84d2-4650-aaf0-5fcfc3570428

fosinopril sodium 20 mg / hydrochlorothiazide 12.5 mg oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001850342ANDAEon Labs, Inc.2005-09-28FOSINOPRIL SODIUM, HYDROCHLOROTHIAZIDEORALTABLETANDA076961ef0261c6-58be-45ee-8a17-d6e7bbc006ba
2231550061ANDAHeritage Pharmaceuticals Inc.2011-11-15FOSINOPRIL SODIUM, HYDROCHLOROTHIAZIDEORALTABLETANDA0790259921249f-e15d-46e1-b4ad-4d6866f30ca6
3572370027ANDACitron Pharma Llc2009-07-09FOSINOPRIL SODIUM, HYDROCHLOROTHIAZIDEORALTABLETANDA079245978a5492-0c73-42ca-a15b-bba3eb70b41e
4633040404ANDARnabaxy Pharmaceuticals Inc.2004-12-20FOSINOPRIL SODIUM, HYDROCHLOROTHIAZIDEORALTABLETANDA07673952ee65a7-ca1f-48fd-8fad-d72ea0dad4de
5658620309ANDAAurobindo Pharma Limited2009-07-09FOSINOPRIL SODIUM, HYDROCHLOROTHIAZIDEORALTABLETANDA07924535019655-9a30-4305-a262-936ad0e73071
6684620555ANDAGlenmark Generics Inc., Usa2009-07-09FOSINOPRIL SODIUM, HYDROCHLOROTHIAZIDEORALTABLETANDA090228dfa547a8-cb88-47e8-b0a7-ec6cd3950358

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548685469ANDAPhysicians Total Care, Inc.2005-11-15FOSINOPRIL SODIUM, HYDROCHLOROTHIAZIDEORALTABLET684620555ANDA090228fa2b99f6-84d2-4650-aaf0-5fcfc3570428

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA076608FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDEACTAVIS LABORATORIES FL INC2004-12-03ANDA076608_001, ANDA076608_002
2ANDA076739FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDESUN PHARMACEUTICAL INDUSTRIES LTD2004-12-17ANDA076739_001, ANDA076739_002
3ANDA076945FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDETrueTEVA PHARMACEUTICALS USA INC2006-07-05ANDA076945_001, ANDA076945_002
4ANDA076961FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDESANDOZ INC2005-09-28ANDA076961_001, ANDA076961_002
5ANDA077144FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDETrueWATSON LABORATORIES INC2005-08-16ANDA077144_001, ANDA077144_002
6ANDA077705FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDETrueMYLAN PHARMACEUTICALS INC2006-08-14ANDA077705_001, ANDA077705_002
7ANDA079025FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDEEMCURE PHARMACEUTICALS LTD INDIA2010-09-17ANDA079025_001, ANDA079025_002
8ANDA079245FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDEAUROBINDO PHARMA LTD2009-07-09ANDA079245_001, ANDA079245_002
9ANDA090228FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDEINVAGEN PHARMACEUTICALS INC2009-07-09ANDA090228_001, ANDA090228_002
10NDA020286MONOPRIL-HCTTrueBRISTOL MYERS SQUIBB1994-11-30NDA020286_001, NDA020286_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA076608_001RXHYDROCHLOROTHIAZIDE (12.5MG), FOSINOPRIL SODIUM (10MG)ORALTABLETFalseAB2004-12-03FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE
2ANDA076608_002RXFOSINOPRIL SODIUM (20MG), HYDROCHLOROTHIAZIDE (12.5MG)ORALTABLETFalseAB2004-12-03FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE
3ANDA076739_001RXFOSINOPRIL SODIUM (10MG), HYDROCHLOROTHIAZIDE (12.5MG)ORALTABLETFalseAB2004-12-17FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE
4ANDA076739_002RXHYDROCHLOROTHIAZIDE (12.5MG), FOSINOPRIL SODIUM (20MG)ORALTABLETFalseAB2004-12-17FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE
5ANDA076945_001discontinuedHYDROCHLOROTHIAZIDE (12.5MG), FOSINOPRIL SODIUM (10MG)ORALTABLETFalse2006-07-05FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE
6ANDA076945_002discontinuedFOSINOPRIL SODIUM (20MG), HYDROCHLOROTHIAZIDE (12.5MG)ORALTABLETFalse2006-07-05FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE
7ANDA076961_001RXFOSINOPRIL SODIUM (10MG), HYDROCHLOROTHIAZIDE (12.5MG)ORALTABLETFalseAB2005-09-28FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE
8ANDA076961_002RXHYDROCHLOROTHIAZIDE (12.5MG), FOSINOPRIL SODIUM (20MG)ORALTABLETFalseAB2005-09-28FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE
9ANDA077144_001discontinuedFOSINOPRIL SODIUM (10MG), HYDROCHLOROTHIAZIDE (12.5MG)ORALTABLETFalse2005-08-16FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE
10ANDA077144_002discontinuedHYDROCHLOROTHIAZIDE (12.5MG), FOSINOPRIL SODIUM (20MG)ORALTABLETFalse2005-08-16FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE
11ANDA077705_001discontinuedHYDROCHLOROTHIAZIDE (12.5MG), FOSINOPRIL SODIUM (10MG)ORALTABLETFalse2006-08-14FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE
12ANDA077705_002discontinuedHYDROCHLOROTHIAZIDE (12.5MG), FOSINOPRIL SODIUM (20MG)ORALTABLETFalse2006-08-14FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE
13ANDA079025_001RXHYDROCHLOROTHIAZIDE (12.5MG), FOSINOPRIL SODIUM (10MG)ORALTABLETFalseAB2010-09-17FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE
14ANDA079025_002RXFOSINOPRIL SODIUM (20MG), HYDROCHLOROTHIAZIDE (12.5MG)ORALTABLETTrueAB2010-09-17FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE
15ANDA079245_001RXHYDROCHLOROTHIAZIDE (12.5MG), FOSINOPRIL SODIUM (10MG)ORALTABLETFalseAB2009-07-09FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE
16ANDA079245_002RXFOSINOPRIL SODIUM (20MG), HYDROCHLOROTHIAZIDE (12.5MG)ORALTABLETFalseAB2009-07-09FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE
17ANDA090228_001RXFOSINOPRIL SODIUM (10MG), HYDROCHLOROTHIAZIDE (12.5MG)ORALTABLETFalseAB2009-07-09FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE
18ANDA090228_002RXHYDROCHLOROTHIAZIDE (12.5MG), FOSINOPRIL SODIUM (20MG)ORALTABLETFalseAB2009-07-09FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE
19NDA020286_001discontinuedFOSINOPRIL SODIUM (20MG), HYDROCHLOROTHIAZIDE (12.5MG)ORALTABLETFalse1994-11-30MONOPRIL-HCT
20NDA020286_002discontinuedHYDROCHLOROTHIAZIDE (12.5MG), FOSINOPRIL SODIUM (10MG)ORALTABLETFalse1994-11-30MONOPRIL-HCT

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
135019655-9a30-4305-a262-936ad0e73071 (view SPL)Fosinopril Sodium and Hydrochlorothiazide Tablets, USP Rx onlyprescriptionHuman PrescriptionAurobindo Pharma LimitedANALYSIS, API MANUFACTURE, MANUFACTURE2013-11-186658620308, 658620309
252ee65a7-ca1f-48fd-8fad-d72ea0dad4de (view SPL)Fosinopril Sodium and Hydrochlorothiazide Tablets, USPRx onlyprescriptionHuman PrescriptionRnabaxy Pharmaceuticals Inc.manufacture2013-11-104633040403, 633040404
3978a5492-0c73-42ca-a15b-bba3eb70b41e (view SPL)Fosinopril Sodium and Hydrochlorothiazide Tablets, USPRx onlyprescriptionHuman PrescriptionCitron Pharma Llc2013-12-161572370026, 572370027
49921249f-e15d-46e1-b4ad-4d6866f30ca6 (view SPL)Rx onlyprescriptionHuman PrescriptionHeritage Pharmaceuticals Inc.ANALYSIS, LABEL, MANUFACTURE, PACK2014-01-3110231550060, 231550061
5dfa547a8-cb88-47e8-b0a7-ec6cd3950358 (view SPL)Fosinopril Sodium and Hydrochlorothiazide Tablets, USPprescriptionHuman PrescriptionGlenmark Generics Inc., UsaANALYSIS, MANUFACTURE2015-11-093684620554, 684620555
6ef0261c6-58be-45ee-8a17-d6e7bbc006ba (view SPL)Fosinopril Sodium and Hydrochlorothiazide TabletsprescriptionHuman PrescriptionEon Labs, Inc.2013-12-0518001850341, 001850342
7fa2b99f6-84d2-4650-aaf0-5fcfc3570428 (view SPL)Fosinopril Sodium and Hydrochlorothiazide Tablets, USPprescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2009-12-071548685346, 548685469

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