Enalapril / Hydrochlorothiazide Oral Tablet

Brand(s)
Vaseretic
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Valeant Pharmaceuticals North America Llc (2015-08-25)
Oldest Current Product
1986-10-31
License(s)
NDA, NDA AUTHORIZED GENERIC, ANDA
RxNORM
ORAL TABLET\ENALAPRIL:HYDROCHLOROTHIAZIDE
FDAOB
ORAL\TABLET\ENALAPRIL MALEATE: HYDROCHLOROTHIAZIDE
SPL Active
ORAL\TABLET\ENALAPRIL MALEATE: HYDROCHLOROTHIAZIDE
SPL Moiety
ORAL\TABLET\ENALAPRIL: HYDROCHLOROTHIAZIDE
ORAL\TABLET\ENALAPRILAT ANHYDROUS: HYDROCHLOROTHIAZIDE

product(s) by strength(s)

enalapril maleate 10 mg / hydrochlorothiazide 25 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001870146VasereticNDAValeant Pharmaceuticals North America Llc1986-10-31ENALAPRIL MALEATE, HYDROCHLOROTHIAZIDEORALTABLETNDA019221bf3007e2-8fcc-48de-8fd5-55e95033d62f

generic product(s)(s)

#idcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formapplicationspl
1000931052ANDATeva Pharmaceuticals Usa Inc2001-09-192016-04-30ENALAPRIL MALEATE, HYDROCHLOROTHIAZIDEORALTABLETANDA0757275cad2f43-3527-4152-820e-209c5179e3b8
2003780723ANDAMylan Pharmaceuticals Inc.2001-09-19ENALAPRIL MALEATE, HYDROCHLOROTHIAZIDEORALTABLETANDA07562432d83d93-85e3-4e9e-b60c-732aa78959c7
3516724046ANDATaro Pharmaceuticals U.S.A., Inc.2001-09-18ENALAPRIL MALEATE, HYDROCHLOROTHIAZIDEORALTABLETANDA0757887cb92cf2-46f2-4379-937c-168d230e43a4
4551110134ANDADr. Reddy'S Laboratories Ltd2001-10-15ENALAPRIL MALEATE, HYDROCHLOROTHIAZIDEORALTABLETANDA075909ed4a55a6-cd6a-c74a-cb93-4b45641691a0
5605050209ANDAApotex Corp2007-06-19ENALAPRIL MALEATE, HYDROCHLOROTHIAZIDEORALTABLETANDA076486cd6edb9c-0f06-2791-b5b4-6e3d78d3b534
6686820146NDA AUTHORIZED GENERICOceanside Pharmaceuticals1986-10-31ENALAPRIL MALEATE, HYDROCHLOROTHIAZIDEORALTABLETNDA019221b452b13f-64ba-4cd0-9007-bfe4c371f17e

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1216950780ANDARebel Distributors Corp2001-09-18ENALAPRIL MALEATE, HYDROCHLOROTHIAZIDEORALTABLET516724046ANDA075788c1d62153-8622-40de-a20b-3faecd718736
2422910269ANDAAvkare, Inc.2013-07-22ENALAPRIL MALEATE, HYDROCHLOROTHIAZIDEORALTABLET000931052ANDA0757277f6b7228-54b7-8299-7c62-a4019e8650eb
3499990823ANDALake Erie Medical Dba Quality Care Products Llc2009-07-23ENALAPRIL MALEATE, HYDROCHLOROTHIAZIDEORALTABLET605050209ANDA0764862d7d3838-318a-494d-9a78-05ad78e35ec4
4548685100ANDAPhysicians Total Care, Inc.2009-07-23ENALAPRIL MALEATE, HYDROCHLOROTHIAZIDEORALTABLET605050209ANDA076486e435ee3d-20b1-449b-8704-b2bf2a579af8
5636293217ANDABryant Ranch Prepack2001-09-18ENALAPRIL MALEATE, HYDROCHLOROTHIAZIDEORALTABLET516724046ANDA075788c9bed6ac-1e4a-453c-a891-b468a24a6ea6

enalapril maleate 5 mg / hydrochlorothiazide 12.5 mg oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formapplicationspl
1000931044ANDATeva Pharmaceuticals Usa Inc2001-09-192015-10-31ENALAPRIL MALEATE, HYDROCHLOROTHIAZIDEORALTABLETANDA0757275cad2f43-3527-4152-820e-209c5179e3b8
2003780712ANDAMylan Pharmaceuticals Inc.2001-09-19ENALAPRIL MALEATE, HYDROCHLOROTHIAZIDEORALTABLETANDA07562432d83d93-85e3-4e9e-b60c-732aa78959c7
3516724045ANDATaro Pharmaceuticals U.S.A., Inc.2001-09-18ENALAPRIL MALEATE, HYDROCHLOROTHIAZIDEORALTABLETANDA0757887cb92cf2-46f2-4379-937c-168d230e43a4
4551110133ANDADr. Reddy'S Laboratories Ltd2001-10-15ENALAPRIL MALEATE, HYDROCHLOROTHIAZIDEORALTABLETANDA075909ed4a55a6-cd6a-c74a-cb93-4b45641691a0
5605050208ANDAApotex Corp2007-06-19ENALAPRIL MALEATE, HYDROCHLOROTHIAZIDEORALTABLETANDA076486cd6edb9c-0f06-2791-b5b4-6e3d78d3b534

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1521250770ANDARemedyrepack Inc.2013-11-12ENALAPRIL MALEATE, HYDROCHLOROTHIAZIDEORALTABLET605050208ANDA076486a342b0fa-0d5f-4594-ae66-5416994475da

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA075624ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDEMYLAN PHARMACEUTICALS INC2001-09-18ANDA075624_001, ANDA075624_002
2ANDA075727ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDEG AND W LABORATORIES INC2001-09-18ANDA075727_001, ANDA075727_002
3ANDA075736ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDETrueIVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA2003-03-25ANDA075736_001, ANDA075736_002
4ANDA075788ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDETARO PHARMACEUTICAL INDUSTRIES LTD2001-09-18ANDA075788_001, ANDA075788_002
5ANDA075909ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDEDR REDDYS LABORATORIES LTD2001-10-15ANDA075909_001, ANDA075909_002
6ANDA076116ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDETrueSANDOZ INC2001-09-19ANDA076116_001, ANDA076116_002
7ANDA076486ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDEAPOTEX INC ETOBICOKE SITE2004-10-27ANDA076486_001, ANDA076486_002
8NDA019221VASERETICVALEANT INTERNATIONAL BARBADOS SRL1986-10-31NDA019221_001, NDA019221_003

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA075624_001RXENALAPRIL MALEATE (5MG), HYDROCHLOROTHIAZIDE (12.5MG)ORALTABLETFalseAB2001-09-18ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE
2ANDA075624_002RXHYDROCHLOROTHIAZIDE (25MG), ENALAPRIL MALEATE (10MG)ORALTABLETFalseAB2001-09-18ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE
3ANDA075727_001RXHYDROCHLOROTHIAZIDE (12.5MG), ENALAPRIL MALEATE (5MG)ORALTABLETFalseAB2001-09-18ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE
4ANDA075727_002RXENALAPRIL MALEATE (10MG), HYDROCHLOROTHIAZIDE (25MG)ORALTABLETFalseAB2001-09-18ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE
5ANDA075736_001discontinuedHYDROCHLOROTHIAZIDE (12.5MG), ENALAPRIL MALEATE (5MG)ORALTABLETFalse2003-03-25ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE
6ANDA075736_002discontinuedENALAPRIL MALEATE (10MG), HYDROCHLOROTHIAZIDE (25MG)ORALTABLETFalse2003-03-25ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE
7ANDA075788_001RXHYDROCHLOROTHIAZIDE (12.5MG), ENALAPRIL MALEATE (5MG)ORALTABLETFalseAB2001-09-18ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE
8ANDA075788_002RXHYDROCHLOROTHIAZIDE (25MG), ENALAPRIL MALEATE (10MG)ORALTABLETFalseAB2001-09-18ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE
9ANDA075909_001RXENALAPRIL MALEATE (5MG), HYDROCHLOROTHIAZIDE (12.5MG)ORALTABLETFalseAB2001-10-15ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE
10ANDA075909_002RXENALAPRIL MALEATE (10MG), HYDROCHLOROTHIAZIDE (25MG)ORALTABLETFalseAB2001-10-15ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE
11ANDA076116_001discontinuedHYDROCHLOROTHIAZIDE (12.5MG), ENALAPRIL MALEATE (5MG)ORALTABLETFalse2001-09-19ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE
12ANDA076116_002discontinuedENALAPRIL MALEATE (10MG), HYDROCHLOROTHIAZIDE (25MG)ORALTABLETFalse2001-09-19ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE
13ANDA076486_001RXHYDROCHLOROTHIAZIDE (12.5MG), ENALAPRIL MALEATE (5MG)ORALTABLETFalseAB2004-10-27ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE
14ANDA076486_002RXHYDROCHLOROTHIAZIDE (25MG), ENALAPRIL MALEATE (10MG)ORALTABLETFalseAB2004-10-27ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE
15NDA019221_001RXENALAPRIL MALEATE (10MG), HYDROCHLOROTHIAZIDE (25MG)ORALTABLETTrueAB1986-10-31VASERETIC
16NDA019221_003RXENALAPRIL MALEATE (5MG), HYDROCHLOROTHIAZIDE (12.5MG)ORALTABLETFalseAB1995-07-12VASERETIC

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
12d7d3838-318a-494d-9a78-05ad78e35ec4 (view SPL)prescriptionHuman PrescriptionLake Erie Medical Dba Quality Care Products Llcrepack2013-08-301499990823
232d83d93-85e3-4e9e-b60c-732aa78959c7 (view SPL)prescriptionHuman PrescriptionMylan Pharmaceuticals Inc.2015-03-238003780712, 003780723
35cad2f43-3527-4152-820e-209c5179e3b8 (view SPL)ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE TABLETS USP, 5 mg/12.5 mg and 10 mg/25 mg10441052Rx onlyprescriptionHuman PrescriptionTeva Pharmaceuticals Usa Inc2015-04-2711000931044, 000931052
47cb92cf2-46f2-4379-937c-168d230e43a4 (view SPL)Enalapril Maleate and Hydrochlorothiazide Tablets, USPprescriptionHuman PrescriptionTaro Pharmaceuticals U.S.A., Inc.MANUFACTURE2015-06-175516724045, 516724046
57f6b7228-54b7-8299-7c62-a4019e8650eb (view SPL)ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDEprescriptionHuman PrescriptionAvkare, Inc.2013-07-222422910269
6a342b0fa-0d5f-4594-ae66-5416994475da (view SPL)Enalapril Maleate and Hydrochlorothiazide Tablets, USP 5/12.5 mg and 10/25 mgprescriptionHuman PrescriptionRemedyrepack Inc.2013-11-121521250770
7b452b13f-64ba-4cd0-9007-bfe4c371f17e (view SPL)ENALAPRIL MALEATE and HYDROCHLOROTHIAZIDE TABLETSprescriptionHuman PrescriptionOceanside PharmaceuticalsMANUFACTURE2014-09-052686820146
8bf3007e2-8fcc-48de-8fd5-55e95033d62f (view SPL)VASERETIC (ENALAPRIL MALEATE-HYDROCHLOROTHIAZIDE)prescriptionHuman PrescriptionValeant Pharmaceuticals North America LlcMANUFACTURE2015-08-2512001870146
9c1d62153-8622-40de-a20b-3faecd718736 (view SPL)ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE TABLETS, USPprescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2010-12-201216950780
10c9bed6ac-1e4a-453c-a891-b468a24a6ea6 (view SPL)Enalapril Maleate and Hydrochlorothiazide Tablets, USPprescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2010-05-101000636293217
11cd6edb9c-0f06-2791-b5b4-6e3d78d3b534 (view SPL)ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE TABLETS, USP 5/12.5 mg and 10/25 mg Rx OnlyprescriptionHuman PrescriptionApotex Corpanalysis, manufacture2015-09-238605050208, 605050209
12e435ee3d-20b1-449b-8704-b2bf2a579af8 (view SPL)prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2009-11-201548685100, 548685503
13ed4a55a6-cd6a-c74a-cb93-4b45641691a0 (view SPL)ENALAPRIL MALEATE ANDHYDROCHLOROTHIAZIDE TABLETS, USPprescriptionHuman PrescriptionDr. Reddy'S Laboratories Ltdanalysis, manufacture2010-02-171551110133, 551110134

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