Hydrochlorothiazide / Spironolactone Oral Tablet

Brand(s)
Aldactazide
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Greenstone Llc (2014-12-02)
Oldest Current Product
1978-01-01
License(s)
NDA, NDA AUTHORIZED GENERIC, ANDA
RxNORM
ORAL TABLET\HYDROCHLOROTHIAZIDE:SPIRONOLACTONE
FDAOB
ORAL\TABLET\HYDROCHLOROTHIAZIDE: SPIRONOLACTONE
SPL Active
ORAL\TABLET, FILM COATED\HYDROCHLOROTHIAZIDE: SPIRONOLACTONE
ORAL\TABLET\HYDROCHLOROTHIAZIDE: SPIRONOLACTONE
SPL Moiety
ORAL\TABLET, FILM COATED\HYDROCHLOROTHIAZIDE: SPIRONOLACTONE
ORAL\TABLET\HYDROCHLOROTHIAZIDE: SPIRONOLACTONE

product(s) by strength(s)

hydrochlorothiazide 25 mg / spironolactone 25 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000251011AldactazideNDAG.D. Searle Llc Division Of Pfizer Inc1978-01-01HYDROCHLOROTHIAZIDE, SPIRONOLACTONEORALTABLET, FILM COATEDNDA012616d44637a7-b980-4bb1-832c-f5a0f73f8259

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003780141ANDAMylan Pharmaceuticals Inc.2012-07-26HYDROCHLOROTHIAZIDE, SPIRONOLACTONEORALTABLETANDA08651366134130-5718-483b-a076-36ecdb0add34
2534890144ANDAMutual Pharmaceutical Company, Inc.1987-07-02HYDROCHLOROTHIAZIDE, SPIRONOLACTONEORALTABLETANDA089534d7fa3c79-9f26-415b-8039-eb2acabcf66b
3597625014NDA AUTHORIZED GENERICGreenstone Llc1978-01-01HYDROCHLOROTHIAZIDE, SPIRONOLACTONEORALTABLET, FILM COATEDNDA012616624f0563-8c94-40e9-8ed0-8cc14950bad2

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1510790104ANDAMylan Institutional Inc.1994-04-11HYDROCHLOROTHIAZIDE, SPIRONOLACTONEORALTABLET003780141ANDA08651399276a7d-591d-4de4-bcac-e9bd53f8dc0e
2545690502NDA AUTHORIZED GENERICA-S Medication Solutions Llc1978-01-01HYDROCHLOROTHIAZIDE, SPIRONOLACTONEORALTABLET, FILM COATED597625014NDA012616bd8779c8-fcb4-4f01-bd0a-20152d46a085
3548680699ANDAPhysicians Total Care, Inc.1993-05-26HYDROCHLOROTHIAZIDE, SPIRONOLACTONEORALTABLET003780141ANDA08651345745495-d53f-4c52-909e-ef12ac437733
4680840946ANDAAmerican Health Packaging2015-03-31HYDROCHLOROTHIAZIDE, SPIRONOLACTONEORALTABLET534890144ANDA0895349cefc817-6d50-440d-9b69-c3abe47273f6

hydrochlorothiazide 50 mg / spironolactone 50 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000251021AldactazideNDAG.D. Searle Llc Division Of Pfizer Inc1978-01-01HYDROCHLOROTHIAZIDE, SPIRONOLACTONEORALTABLET, FILM COATEDNDA012616d44637a7-b980-4bb1-832c-f5a0f73f8259

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA085974SPIRONOLACTONE W/ HYDROCHLOROTHIAZIDETrueWATSON LABORATORIES INCANDA085974_001
2ANDA086026SPIRONOLACTONE W/ HYDROCHLOROTHIAZIDETrueWATSON LABORATORIES INCANDA086026_001
3ANDA086513SPIRONOLACTONE AND HYDROCHLOROTHIAZIDEMYLAN PHARMACEUTICALS INCANDA086513_001
4ANDA086881SPIRONOLACTONE AND HYDROCHLOROTHIAZIDETrueSANDOZ INCANDA086881_001
5ANDA087004SPIRONOLACTONE W/ HYDROCHLOROTHIAZIDETrueIVAX PHARMACEUTICALS INC1982-05-24ANDA087004_002
6ANDA087267SPIRONOLACTONE AND HYDROCHLOROTHIAZIDETrueMUTUAL PHARMACEUTICAL CO INCANDA087267_001
7ANDA087398SPIRONOLACTONE AND HYDROCHLOROTHIAZIDETrueWATSON LABORATORIES INCANDA087398_001
8ANDA087511SPIRONOLACTONE W/ HYDROCHLOROTHIAZIDETrueLEDERLE LABORATORIES DIV AMERICAN CYANAMID COANDA087511_001
9ANDA087553SPIRONOLACTONE W/ HYDROCHLOROTHIAZIDETrueUPSHER SMITH LABORATORIES INCANDA087553_001
10ANDA087651SPIRONOLACTONE W/ HYDROCHLOROTHIAZIDETrueUSL PHARMA INCANDA087651_001
11ANDA087655SPIRONOLACTONE W/ HYDROCHLOROTHIAZIDETrueVANGARD LABORATORIES INC DIV MIDWAY MEDICAL COANDA087655_001
12ANDA087948SPIRONOLACTONE W/ HYDROCHLOROTHIAZIDETruePARKE DAVIS DIV WARNER LAMBERT CO1983-02-22ANDA087948_001
13ANDA087999SPIRONOLACTONE AND HYDROCHLOROTHIAZIDETruePUREPAC PHARMACEUTICAL CO1985-11-06ANDA087999_001
14ANDA088025SPIRONOLACTONE AND HYDROCHLOROTHIAZIDETrueASCOT HOSP PHARMACEUTICALS INC DIV TRAVENOL LABORATORIES INC1984-11-23ANDA088025_001
15ANDA088054SPIRONOLACTONE W/ HYDROCHLOROTHIAZIDETruePUREPAC PHARMACEUTICAL CO1983-08-18ANDA088054_001
16ANDA089137SPIRONOLACTONE AND HYDROCHLOROTHIAZIDETrueSUPERPHARM CORP1985-08-26ANDA089137_001
17ANDA089534SPIRONOLACTONE AND HYDROCHLOROTHIAZIDEMUTUAL PHARMACEUTICAL CO INC1987-07-02ANDA089534_001
18NDA012616ALDACTAZIDEGD SEARLE LLC1982-12-30NDA012616_004, NDA012616_005

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA085974_001discontinuedSPIRONOLACTONE (25MG), HYDROCHLOROTHIAZIDE (25MG)ORALTABLETFalseSPIRONOLACTONE W/ HYDROCHLOROTHIAZIDE
2ANDA086026_001discontinuedHYDROCHLOROTHIAZIDE (25MG), SPIRONOLACTONE (25MG)ORALTABLETFalseSPIRONOLACTONE W/ HYDROCHLOROTHIAZIDE
3ANDA086513_001RXHYDROCHLOROTHIAZIDE (25MG), SPIRONOLACTONE (25MG)ORALTABLETFalseABSPIRONOLACTONE AND HYDROCHLOROTHIAZIDE
4ANDA086881_001discontinuedSPIRONOLACTONE (25MG), HYDROCHLOROTHIAZIDE (25MG)ORALTABLETFalseSPIRONOLACTONE AND HYDROCHLOROTHIAZIDE
5ANDA087004_002discontinuedHYDROCHLOROTHIAZIDE (25MG), SPIRONOLACTONE (25MG)ORALTABLETFalse1982-05-24SPIRONOLACTONE W/ HYDROCHLOROTHIAZIDE
6ANDA087267_001discontinuedSPIRONOLACTONE (25MG), HYDROCHLOROTHIAZIDE (25MG)ORALTABLETFalseSPIRONOLACTONE AND HYDROCHLOROTHIAZIDE
7ANDA087398_001discontinuedHYDROCHLOROTHIAZIDE (25MG), SPIRONOLACTONE (25MG)ORALTABLETFalseSPIRONOLACTONE AND HYDROCHLOROTHIAZIDE
8ANDA087511_001discontinuedHYDROCHLOROTHIAZIDE (25MG), SPIRONOLACTONE (25MG)ORALTABLETFalseSPIRONOLACTONE W/ HYDROCHLOROTHIAZIDE
9ANDA087553_001discontinuedSPIRONOLACTONE (25MG), HYDROCHLOROTHIAZIDE (25MG)ORALTABLETFalseSPIRONOLACTONE W/ HYDROCHLOROTHIAZIDE
10ANDA087651_001discontinuedHYDROCHLOROTHIAZIDE (25MG), SPIRONOLACTONE (25MG)ORALTABLETFalseSPIRONOLACTONE W/ HYDROCHLOROTHIAZIDE
11ANDA087655_001discontinuedHYDROCHLOROTHIAZIDE (25MG), SPIRONOLACTONE (25MG)ORALTABLETFalseSPIRONOLACTONE W/ HYDROCHLOROTHIAZIDE
12ANDA087948_001discontinuedHYDROCHLOROTHIAZIDE (25MG), SPIRONOLACTONE (25MG)ORALTABLETFalse1983-02-22SPIRONOLACTONE W/ HYDROCHLOROTHIAZIDE
13ANDA087999_001discontinuedSPIRONOLACTONE (25MG), HYDROCHLOROTHIAZIDE (25MG)ORALTABLETFalse1985-11-06SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE
14ANDA088025_001discontinuedSPIRONOLACTONE (25MG), HYDROCHLOROTHIAZIDE (25MG)ORALTABLETFalse1984-11-23SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE
15ANDA088054_001discontinuedSPIRONOLACTONE (25MG), HYDROCHLOROTHIAZIDE (25MG)ORALTABLETFalse1983-08-18SPIRONOLACTONE W/ HYDROCHLOROTHIAZIDE
16ANDA089137_001discontinuedHYDROCHLOROTHIAZIDE (25MG), SPIRONOLACTONE (25MG)ORALTABLETFalse1985-08-26SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE
17ANDA089534_001RXHYDROCHLOROTHIAZIDE (25MG), SPIRONOLACTONE (25MG)ORALTABLETFalseAB1987-07-02SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE
18NDA012616_004RXSPIRONOLACTONE (25MG), HYDROCHLOROTHIAZIDE (25MG)ORALTABLETFalseAB1982-12-30ALDACTAZIDE
19NDA012616_005RXSPIRONOLACTONE (50MG), HYDROCHLOROTHIAZIDE (50MG)ORALTABLETTrue1982-12-30ALDACTAZIDE

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
145745495-d53f-4c52-909e-ef12ac437733 (view SPL)prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2010-06-011548680699
2624f0563-8c94-40e9-8ed0-8cc14950bad2 (view SPL)Spironolactone and Hydrochlorothiazide TabletsprescriptionHuman PrescriptionGreenstone LlcANALYSIS, API MANUFACTURE, MANUFACTURE, PACK2014-12-027597625014
366134130-5718-483b-a076-36ecdb0add34 (view SPL)prescriptionHuman PrescriptionMylan Pharmaceuticals Inc.2015-05-074003780141
499276a7d-591d-4de4-bcac-e9bd53f8dc0e (view SPL)prescriptionHuman PrescriptionMylan Institutional Inc.2012-12-072510790104
59cefc817-6d50-440d-9b69-c3abe47273f6 (view SPL)SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE TABLETS USPprescriptionHuman PrescriptionAmerican Health PackagingREPACK2015-09-182680840946
6bd8779c8-fcb4-4f01-bd0a-20152d46a085 (view SPL)Spironolactone and Hydrochlorothiazide TabletsprescriptionHuman PrescriptionA-S Medication Solutions Llcrepack2013-06-171545690502
7d44637a7-b980-4bb1-832c-f5a0f73f8259 (view SPL)Aldactazide spironolactone andhydrochlorothiazide tabletsprescriptionHuman PrescriptionG.D. Searle Llc Division Of Pfizer IncANALYSIS, API MANUFACTURE, LABEL, MANUFACTURE, PACK2014-11-0313000251011, 000251021
8d7fa3c79-9f26-415b-8039-eb2acabcf66b (view SPL)SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE TABLETS USP 25 mg / 25 mgprescriptionHuman PrescriptionMutual Pharmaceutical Company, Inc.2014-12-088534890144

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