Hydrochlorothiazide / quinapril Oral Tablet

Brand(s)
Accuretic
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Greenstone Llc (2015-10-13)
Oldest Current Product
1999-12-28
License(s)
NDA, NDA AUTHORIZED GENERIC, ANDA
RxNORM
ORAL TABLET\HYDROCHLOROTHIAZIDE:QUINAPRIL
FDAOB
ORAL\TABLET\HYDROCHLOROTHIAZIDE: QUINAPRIL HYDROCHLORIDE
SPL Active
ORAL\TABLET, FILM COATED\HYDROCHLOROTHIAZIDE: QUINAPRIL HYDROCHLORIDE
ORAL\TABLET\HYDROCHLOROTHIAZIDE: QUINAPRIL HYDROCHLORIDE
SPL Moiety
ORAL\TABLET, FILM COATED\HYDROCHLOROTHIAZIDE: QUINAPRIL
ORAL\TABLET, FILM COATED\HYDROCHLOROTHIAZIDE: QUINAPRILAT
ORAL\TABLET\HYDROCHLOROTHIAZIDE: QUINAPRILAT

product(s) by strength(s)

hydrochlorothiazide 12.5 mg / quinapril 10 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000710222AccureticNDAParke-Davis Div Of Pfizer Inc1999-12-28HYDROCHLOROTHIAZIDE, QUINAPRIL HYDROCHLORIDEORALTABLET, FILM COATEDNDA02012580e9d61d-9674-4ac4-b84c-79a875d408dd

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003780542ANDAMylan Pharmaceuticals Inc.2007-02-26HYDROCHLOROTHIAZIDE, QUINAPRIL HYDROCHLORIDEORALTABLET, FILM COATEDANDA077093845356a8-221c-41ec-9ac4-a1a114365275
2317220374ANDACamber Pharmaceuticals, Inc.2011-12-15HYDROCHLOROTHIAZIDE, QUINAPRIL HYDROCHLORIDEORALTABLETANDA2013567e97959c-d34d-4a6e-99f0-a821d5ce5089
3433860710ANDAGavis Pharmaceuticals, Llc2011-07-15HYDROCHLOROTHIAZIDE, QUINAPRIL HYDROCHLORIDEORALTABLETANDA076374383ecaa6-29c8-4280-a442-c47f101d7c88
4597620222NDA AUTHORIZED GENERICGreenstone Llc1999-12-28HYDROCHLOROTHIAZIDE, QUINAPRIL HYDROCHLORIDEORALTABLET, FILM COATEDNDA020125a4985462-793f-45ab-bbee-43bc9d1135ce
5605053409ANDAApotex Corp2013-03-12HYDROCHLOROTHIAZIDE, QUINAPRIL HYDROCHLORIDEORALTABLET, FILM COATEDANDA091524ae34a8e0-5f82-4aa8-d71c-b7a3f720925c
6633040161ANDARnabaxy Pharmaceuticals Inc.2009-03-04HYDROCHLOROTHIAZIDE, QUINAPRIL HYDROCHLORIDEORALTABLET, FILM COATEDANDA078211b630824c-bee7-4a78-9349-d995c1eb0f16
7658620161ANDAAurobindo Pharma Limited2007-08-24HYDROCHLOROTHIAZIDE, QUINAPRIL HYDROCHLORIDEORALTABLET, FILM COATEDANDA07845050a58159-9572-4445-9859-b392632597da

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1422910705ANDAAvkare, Inc.2012-08-02HYDROCHLOROTHIAZIDE, QUINAPRIL HYDROCHLORIDEORALTABLET317220374ANDA201356e61f57df-827c-efbd-ac1f-9e7fc1b47480
2548681802ANDAPhysicians Total Care, Inc.2007-02-14HYDROCHLOROTHIAZIDE, QUINAPRIL HYDROCHLORIDEORALTABLET, FILM COATED633040161ANDA078211ba72b914-1252-4370-9b4b-0105186ffb42

hydrochlorothiazide 12.5 mg / quinapril 20 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000710220AccureticNDAParke-Davis Div Of Pfizer Inc1999-12-28HYDROCHLOROTHIAZIDE, QUINAPRIL HYDROCHLORIDEORALTABLET, FILM COATEDNDA02012580e9d61d-9674-4ac4-b84c-79a875d408dd

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003780543ANDAMylan Pharmaceuticals Inc.2007-02-26HYDROCHLOROTHIAZIDE, QUINAPRIL HYDROCHLORIDEORALTABLET, FILM COATEDANDA077093845356a8-221c-41ec-9ac4-a1a114365275
2317220375ANDACamber Pharmaceuticals, Inc.2011-12-15HYDROCHLOROTHIAZIDE, QUINAPRIL HYDROCHLORIDEORALTABLETANDA2013567e97959c-d34d-4a6e-99f0-a821d5ce5089
3433860711ANDAGavis Pharmaceuticals, Llc2011-07-15HYDROCHLOROTHIAZIDE, QUINAPRIL HYDROCHLORIDEORALTABLETANDA076374383ecaa6-29c8-4280-a442-c47f101d7c88
4597620220NDA AUTHORIZED GENERICGreenstone Llc1999-12-28HYDROCHLOROTHIAZIDE, QUINAPRIL HYDROCHLORIDEORALTABLET, FILM COATEDNDA020125a4985462-793f-45ab-bbee-43bc9d1135ce
5605053410ANDAApotex Corp2013-03-12HYDROCHLOROTHIAZIDE, QUINAPRIL HYDROCHLORIDEORALTABLET, FILM COATEDANDA091524ae34a8e0-5f82-4aa8-d71c-b7a3f720925c
6633040162ANDARnabaxy Pharmaceuticals Inc.2009-03-04HYDROCHLOROTHIAZIDE, QUINAPRIL HYDROCHLORIDEORALTABLET, FILM COATEDANDA078211b630824c-bee7-4a78-9349-d995c1eb0f16
7658620162ANDAAurobindo Pharma Limited2007-08-24HYDROCHLOROTHIAZIDE, QUINAPRIL HYDROCHLORIDEORALTABLET, FILM COATEDANDA07845050a58159-9572-4445-9859-b392632597da

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1353560998ANDALake Erie Medical Dba Quality Care Products Llc2007-08-24HYDROCHLOROTHIAZIDE, QUINAPRIL HYDROCHLORIDEORALTABLET, FILM COATED658620162ANDA078450c3c8e14c-d226-4d2b-bfe5-9246bba86369
2422910706ANDAAvkare, Inc.2012-08-02HYDROCHLOROTHIAZIDE, QUINAPRIL HYDROCHLORIDEORALTABLET317220375ANDA201356e61f57df-827c-efbd-ac1f-9e7fc1b47480
3548682847ANDAPhysicians Total Care, Inc.2006-08-03HYDROCHLOROTHIAZIDE, QUINAPRIL HYDROCHLORIDEORALTABLET, FILM COATED633040162ANDA078211ba72b914-1252-4370-9b4b-0105186ffb42

hydrochlorothiazide 25 mg / quinapril 20 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000710223AccureticNDAParke-Davis Div Of Pfizer Inc1999-12-28HYDROCHLOROTHIAZIDE, QUINAPRIL HYDROCHLORIDEORALTABLET, FILM COATEDNDA02012580e9d61d-9674-4ac4-b84c-79a875d408dd

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003780544ANDAMylan Pharmaceuticals Inc.2007-02-26HYDROCHLOROTHIAZIDE, QUINAPRIL HYDROCHLORIDEORALTABLET, FILM COATEDANDA077093845356a8-221c-41ec-9ac4-a1a114365275
2317220376ANDACamber Pharmaceuticals, Inc.2011-12-15HYDROCHLOROTHIAZIDE, QUINAPRIL HYDROCHLORIDEORALTABLETANDA2013567e97959c-d34d-4a6e-99f0-a821d5ce5089
3433860712ANDAGavis Pharmaceuticals, Llc2011-07-15HYDROCHLOROTHIAZIDE, QUINAPRIL HYDROCHLORIDEORALTABLETANDA076374383ecaa6-29c8-4280-a442-c47f101d7c88
4597620223NDA AUTHORIZED GENERICGreenstone Llc1999-12-28HYDROCHLOROTHIAZIDE, QUINAPRIL HYDROCHLORIDEORALTABLET, FILM COATEDNDA020125a4985462-793f-45ab-bbee-43bc9d1135ce
5605053411ANDAApotex Corp2013-03-12HYDROCHLOROTHIAZIDE, QUINAPRIL HYDROCHLORIDEORALTABLET, FILM COATEDANDA091524ae34a8e0-5f82-4aa8-d71c-b7a3f720925c
6633040163ANDARnabaxy Pharmaceuticals Inc.2009-03-04HYDROCHLOROTHIAZIDE, QUINAPRIL HYDROCHLORIDEORALTABLET, FILM COATEDANDA078211b630824c-bee7-4a78-9349-d995c1eb0f16
7658620163ANDAAurobindo Pharma Limited2007-08-24HYDROCHLOROTHIAZIDE, QUINAPRIL HYDROCHLORIDEORALTABLET, FILM COATEDANDA07845050a58159-9572-4445-9859-b392632597da

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1422910707ANDAAvkare, Inc.2012-08-02HYDROCHLOROTHIAZIDE, QUINAPRIL HYDROCHLORIDEORALTABLET317220376ANDA201356e61f57df-827c-efbd-ac1f-9e7fc1b47480
2548685475ANDAPhysicians Total Care, Inc.2008-01-01HYDROCHLOROTHIAZIDE, QUINAPRIL HYDROCHLORIDEORALTABLET, FILM COATED633040163ANDA078211ba72b914-1252-4370-9b4b-0105186ffb42

application(s)

#idtitleapplicantapprovedapproved drug
1ANDA076374QUINARETICGAVIS PHARMACEUTICALS LLC2004-03-31ANDA076374_001, ANDA076374_002, ANDA076374_003
2ANDA077093QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDEMYLAN PHARMACEUTICALS INC2005-03-28ANDA077093_001, ANDA077093_002, ANDA077093_003
3ANDA078211QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDESUN PHARMACEUTICAL INDUSTRIES LTD2009-03-04ANDA078211_001, ANDA078211_002, ANDA078211_003
4ANDA078450QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDEAUROBINDO PHARMA LTD2007-08-24ANDA078450_001, ANDA078450_002, ANDA078450_003
5ANDA091524QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDEAPOTEX CORP2013-03-12ANDA091524_001, ANDA091524_002, ANDA091524_003
6ANDA201356QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDEINVAGEN PHARMACEUTICALS INC2011-04-20ANDA201356_001, ANDA201356_002, ANDA201356_003
7NDA020125ACCURETICPFIZER PHARMACEUTICALS LTD1999-12-28NDA020125_001, NDA020125_002, NDA020125_003

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA076374_001RXQUINAPRIL HYDROCHLORIDE (EQ 10MG BASE), HYDROCHLOROTHIAZIDE (12.5MG)ORALTABLETFalseAB2004-03-31QUINARETIC
2ANDA076374_002RXHYDROCHLOROTHIAZIDE (12.5MG), QUINAPRIL HYDROCHLORIDE (EQ 20MG BASE)ORALTABLETFalseAB2004-03-31QUINARETIC
3ANDA076374_003RXHYDROCHLOROTHIAZIDE (25MG), QUINAPRIL HYDROCHLORIDE (EQ 20MG BASE)ORALTABLETFalseAB2004-03-31QUINARETIC
4ANDA077093_001RXHYDROCHLOROTHIAZIDE (12.5MG), QUINAPRIL HYDROCHLORIDE (EQ 10MG BASE)ORALTABLETFalseAB2005-03-28QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
5ANDA077093_002RXQUINAPRIL HYDROCHLORIDE (EQ 20MG BASE), HYDROCHLOROTHIAZIDE (12.5MG)ORALTABLETFalseAB2005-03-28QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
6ANDA077093_003RXQUINAPRIL HYDROCHLORIDE (EQ 20MG BASE), HYDROCHLOROTHIAZIDE (25MG)ORALTABLETFalseAB2005-03-28QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
7ANDA078211_001RXQUINAPRIL HYDROCHLORIDE (EQ 10MG BASE), HYDROCHLOROTHIAZIDE (12.5MG)ORALTABLETFalseAB2009-03-04QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
8ANDA078211_002RXHYDROCHLOROTHIAZIDE (12.5MG), QUINAPRIL HYDROCHLORIDE (EQ 20MG BASE)ORALTABLETFalseAB2009-03-04QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
9ANDA078211_003RXQUINAPRIL HYDROCHLORIDE (EQ 20MG BASE), HYDROCHLOROTHIAZIDE (25MG)ORALTABLETFalseAB2009-03-04QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
10ANDA078450_001RXHYDROCHLOROTHIAZIDE (12.5MG), QUINAPRIL HYDROCHLORIDE (EQ 10MG BASE)ORALTABLETFalseAB2007-08-24QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
11ANDA078450_002RXQUINAPRIL HYDROCHLORIDE (EQ 20MG BASE), HYDROCHLOROTHIAZIDE (12.5MG)ORALTABLETFalseAB2007-08-24QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
12ANDA078450_003RXHYDROCHLOROTHIAZIDE (25MG), QUINAPRIL HYDROCHLORIDE (EQ 20MG BASE)ORALTABLETFalseAB2007-08-24QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
13ANDA091524_001RXHYDROCHLOROTHIAZIDE (12.5MG), QUINAPRIL HYDROCHLORIDE (EQ 10MG BASE)ORALTABLETFalseAB2013-03-12QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
14ANDA091524_002RXQUINAPRIL HYDROCHLORIDE (EQ 20MG BASE), HYDROCHLOROTHIAZIDE (12.5MG)ORALTABLETFalseAB2013-03-12QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
15ANDA091524_003RXQUINAPRIL HYDROCHLORIDE (EQ 20MG BASE), HYDROCHLOROTHIAZIDE (25MG)ORALTABLETFalseAB2013-03-12QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
16ANDA201356_001RXQUINAPRIL HYDROCHLORIDE (10MG), HYDROCHLOROTHIAZIDE (12.5MG)ORALTABLETFalseAB2011-04-20QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
17ANDA201356_002RXQUINAPRIL HYDROCHLORIDE (20MG), HYDROCHLOROTHIAZIDE (12.5MG)ORALTABLETFalseAB2011-04-20QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
18ANDA201356_003RXHYDROCHLOROTHIAZIDE (25MG), QUINAPRIL HYDROCHLORIDE (20MG)ORALTABLETFalseAB2011-04-20QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
19NDA020125_001RXQUINAPRIL HYDROCHLORIDE (EQ 10MG BASE), HYDROCHLOROTHIAZIDE (12.5MG)ORALTABLETFalseAB1999-12-28ACCURETIC
20NDA020125_002RXHYDROCHLOROTHIAZIDE (12.5MG), QUINAPRIL HYDROCHLORIDE (EQ 20MG BASE)ORALTABLETFalseAB1999-12-28ACCURETIC
21NDA020125_003RXQUINAPRIL HYDROCHLORIDE (EQ 20MG BASE), HYDROCHLOROTHIAZIDE (25MG)ORALTABLETTrueAB1999-12-28ACCURETIC

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1383ecaa6-29c8-4280-a442-c47f101d7c88 (view SPL)QUINAPRIL HCL AND HYDROCHLOROTHIAZIDE tablet Gavis Pharmaceuticals, LLC. Rx OnlyprescriptionHuman PrescriptionGavis Pharmaceuticals, LlcANALYSIS, MANUFACTURE2013-10-012433860710, 433860711, 433860712
250a58159-9572-4445-9859-b392632597da (view SPL)Quinapril and Hydrochlorothiazide Tablets, USP Rx onlyprescriptionHuman PrescriptionAurobindo Pharma LimitedANALYSIS, API MANUFACTURE, MANUFACTURE2015-10-0313658620161, 658620162, 658620163
37e97959c-d34d-4a6e-99f0-a821d5ce5089 (view SPL)Quinapril Hydrochloride and Hydrochlorothiazide Tablets, USP Rx OnlyprescriptionHuman PrescriptionCamber Pharmaceuticals, Inc.ANALYSIS, MANUFACTURE2015-10-138317220374, 317220375, 317220376
480e9d61d-9674-4ac4-b84c-79a875d408dd (view SPL)ACCURETIC (quinapril HCl/hydrochlorothiazide) TabletsprescriptionHuman PrescriptionParke-Davis Div Of Pfizer IncANALYSIS, API MANUFACTURE, LABEL, MANUFACTURE, PACK2015-10-1317000710220, 000710222, 000710223
5845356a8-221c-41ec-9ac4-a1a114365275 (view SPL)prescriptionHuman PrescriptionMylan Pharmaceuticals Inc.2015-09-169003780542, 003780543, 003780544
6a4985462-793f-45ab-bbee-43bc9d1135ce (view SPL)Quinapril HCl/Hydrochlorothiazide TabletsprescriptionHuman PrescriptionGreenstone LlcANALYSIS, API MANUFACTURE, MANUFACTURE, PACK2015-10-1318597620220, 597620222, 597620223
7ae34a8e0-5f82-4aa8-d71c-b7a3f720925c (view SPL)QUINAPRIL HYDROCLORIDE AND HYDROCHLOROTHIAZIDE TABLETS, USP 10 mg/12.5 mg, 20 mg/12.5 mg and 20 mg/25 mg Rx onlyprescriptionHuman PrescriptionApotex Corpanalysis, manufacture2014-05-296605053409, 605053410, 605053411
8b630824c-bee7-4a78-9349-d995c1eb0f16 (view SPL)prescriptionHuman PrescriptionRnabaxy Pharmaceuticals Inc.API MANUFACTURE, MANUFACTURE, PACK2014-12-057633040161, 633040162, 633040163
9ba72b914-1252-4370-9b4b-0105186ffb42 (view SPL)prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2010-05-061548681802, 548682847, 548685475
10c3c8e14c-d226-4d2b-bfe5-9246bba86369 (view SPL)Quinapril Hydrochloride/Hydrochlorothiazide TabletsprescriptionHuman PrescriptionLake Erie Medical Dba Quality Care Products Llcrepack2013-07-161353560998
11e61f57df-827c-efbd-ac1f-9e7fc1b47480 (view SPL)Quinapril Hydrochloride and Hydrochlorothiazide Tablets Rx OnlyprescriptionHuman PrescriptionAvkare, Inc.2012-08-021422910705, 422910706, 422910707

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