Hydrochlorothiazide / Triamterene Oral Capsule

Brand(s)
Dyazide
Category(s)
prescription
SPL Type(s)
Human Prescription, Human Prescription with Highlights
Master SPL
Sandoz Inc (2012-01-25)
Oldest Current Product
1991-07-31
License(s)
NDA, ANDA
RxNORM
ORAL CAPSULE\HYDROCHLOROTHIAZIDE:TRIAMTERENE
FDAOB
ORAL\CAPSULE\HYDROCHLOROTHIAZIDE: TRIAMTERENE
SPL Active
ORAL\CAPSULE\HYDROCHLOROTHIAZIDE: TRIAMTERENE
SPL Moiety
ORAL\CAPSULE\HYDROCHLOROTHIAZIDE: TRIAMTERENE

product(s) by strength(s)

hydrochlorothiazide 25 mg / triamterene 37.5 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000073650DyazideNDAGlaxosmithkline Llc1994-03-30HYDROCHLOROTHIAZIDE, TRIAMTERENEORALCAPSULENDA016042f6eba4b6-9cd0-4c86-46a8-05a202641c89

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003782537ANDAMylan Pharmaceuticals Inc.1996-06-07HYDROCHLOROTHIAZIDE, TRIAMTERENEORALCAPSULEANDA0747011c1277f3-1936-40f2-8efa-4233c39f93a0
2005271632ANDALannett Company, Inc.2011-12-12HYDROCHLOROTHIAZIDE, TRIAMTERENEORALCAPSULEANDA201407b23d4978-0d47-457a-8176-0e8c567d5dd1
3007812074ANDASandoz Inc1997-06-05HYDROCHLOROTHIAZIDE, TRIAMTERENEORALCAPSULEANDA07482181a11c2e-5cfd-4dbd-9f8c-b50b7b2e62fc

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1006151333ANDANcs Healthcare Of Ky, Inc Dba Vangard Labs2011-05-04HYDROCHLOROTHIAZIDE, TRIAMTERENEORALCAPSULE003782537ANDA074701549ba070-55a8-4eb3-9120-d8fe99d4d5e3
2216950839ANDARebel Distributors Corp1997-06-05HYDROCHLOROTHIAZIDE, TRIAMTERENEORALCAPSULE007812074ANDA07482121c7fb80-4f9f-41eb-bebb-eda511980284
3353560974ANDALake Erie Medical Dba Quality Care Products Llc1997-06-05HYDROCHLOROTHIAZIDE, TRIAMTERENEORALCAPSULE007812074ANDA074821cb2b4ca7-067e-4ee2-9550-e54ee6b5edb1
4422910841ANDAAvkare, Inc.2012-07-03HYDROCHLOROTHIAZIDE, TRIAMTERENEORALCAPSULE005271632ANDA2014077888c0eb-f5c9-dd04-c790-b1e8a4c6068a
5458650402ANDAMedsource Pharmaceuticals1997-06-05HYDROCHLOROTHIAZIDE, TRIAMTERENEORALCAPSULE007812074ANDA0748211d631948-6491-7270-e054-00144ff88e88
6499990066ANDALake Erie Medical Dba Quality Care Products Llc2011-05-04HYDROCHLOROTHIAZIDE, TRIAMTERENEORALCAPSULE003782537ANDA074701e1535638-598a-4d5e-b8e1-31abe65400d2
7510790935ANDAMylan Institutional Inc.2000-04-01HYDROCHLOROTHIAZIDE, TRIAMTERENEORALCAPSULE003782537ANDA0747012ebee624-71ee-4ebb-8bad-555f8d0dbac2
8521250420ANDARemedyrepack Inc.2013-05-15, 2013-05-24HYDROCHLOROTHIAZIDE, TRIAMTERENEORALCAPSULE005271632ANDA20140723e4b35c-9721-4af5-842a-f9fac356c662, 2b9623b3-3757-43f8-ab67-47895bbc92b4
9538080802ANDAState Of Florida Doh Central Pharmacy2009-07-01HYDROCHLOROTHIAZIDE, TRIAMTERENEORALCAPSULE003782537ANDA074701c44e8537-145f-4221-b077-d26701078989
10538080803ANDAState Of Florida Doh Central Pharmacy2009-07-01HYDROCHLOROTHIAZIDE, TRIAMTERENEORALCAPSULE007812074ANDA0748211a1ba6bd-e1f4-4928-a32b-a63416ce8681
11548685113ANDAPhysicians Total Care, Inc.2004-10-06HYDROCHLOROTHIAZIDE, TRIAMTERENEORALCAPSULE007812074ANDA0748212edaac6a-9fa2-48ba-bfae-3a79381482fb
12551544510DyazideNDACardinal Health1994-03-30HYDROCHLOROTHIAZIDE, TRIAMTERENEORALCAPSULE000073650NDA0160427330f40d-b269-425b-a4e3-e7263a088fb7
13607600535ANDASt Marys Medical Park Pharmacy2014-04-21HYDROCHLOROTHIAZIDE, TRIAMTERENEORALCAPSULE005271632ANDA20140702cdbfdd-0696-417e-ac67-6fede0d9d3dd
14631870465ANDAProficient Rx Lp1997-06-05HYDROCHLOROTHIAZIDE, TRIAMTERENEORALCAPSULE007812074ANDA074821f11598d2-87ee-4292-8631-c29c54f4dfa9
15636291507ANDABryant Ranch Prepack1997-06-05HYDROCHLOROTHIAZIDE, TRIAMTERENEORALCAPSULE007812074ANDA07482126d46abd-8d8e-4124-9e23-07436521752e
16680840840ANDAAmerican Health Packaging2015-03-30HYDROCHLOROTHIAZIDE, TRIAMTERENEORALCAPSULE005271632ANDA2014075171e219-38cb-4f4d-b33b-abbd713bf642

hydrochlorothiazide 25 mg / triamterene 50 mg oral capsule

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1007812715ANDASandoz Inc1991-07-31HYDROCHLOROTHIAZIDE, TRIAMTERENEORALCAPSULEANDA07319181a11c2e-5cfd-4dbd-9f8c-b50b7b2e62fc

relabeler product(s)(s)

#idcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548680932ANDAPhysicians Total Care, Inc.2003-08-282011-06-30HYDROCHLOROTHIAZIDE, TRIAMTERENEORALCAPSULE007812715ANDA0731912edaac6a-9fa2-48ba-bfae-3a79381482fb
2552890725ANDAPd-Rx Pharmaceuticals, Inc.1991-07-31HYDROCHLOROTHIAZIDE, TRIAMTERENEORALCAPSULE007812715ANDA073191271eb9bb-77de-49f5-854e-085a909a35a8
3636294112ANDABryant Ranch Prepack1991-07-31HYDROCHLOROTHIAZIDE, TRIAMTERENEORALCAPSULE007812715ANDA073191584ddc7a-c288-4b7d-8851-b2e3a384eab9

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA071737TRIAMTERENE AND HYDROCHLOROTHIAZIDETrueVITARINE PHARMACEUTICALS INC1988-02-12ANDA071737_001
2ANDA073191TRIAMTERENE AND HYDROCHLOROTHIAZIDESANDOZ INC1991-07-31ANDA073191_001
3ANDA074259TRIAMTERENE AND HYDROCHLOROTHIAZIDEIVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA1995-03-30ANDA074259_001
4ANDA074701TRIAMTERENE AND HYDROCHLOROTHIAZIDEMYLAN PHARMACEUTICALS INC1996-06-07ANDA074701_001
5ANDA074821TRIAMTERENE AND HYDROCHLOROTHIAZIDESANDOZ INC1997-06-05ANDA074821_001
6ANDA074857TRIAMTERENE AND HYDROCHLOROTHIAZIDETrueNOVARTIS PHARMACEUTICALS CORP1997-09-09ANDA074857_001
7ANDA074970TRIAMTERENE AND HYDROCHLOROTHIAZIDETrueANI PHARMACEUTICALS INC1998-01-06ANDA074970_001
8ANDA075052TRIAMTERENE AND HYDROCHLOROTHIAZIDEDURAMED PHARMACEUTICALS INC SUB BARR LABORATORIES INC1999-06-18ANDA075052_001
9ANDA201407TRIAMTERENE AND HYDROCHLOROTHIAZIDELANNETT HOLDINGS INC2011-12-09ANDA201407_001
10NDA016042DYAZIDEGLAXOSMITHKLINE LLCNDA016042_002, NDA016042_003

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA071737_001discontinuedTRIAMTERENE (50MG), HYDROCHLOROTHIAZIDE (25MG)ORALCAPSULEFalse1988-02-12TRIAMTERENE AND HYDROCHLOROTHIAZIDE
2ANDA073191_001RXHYDROCHLOROTHIAZIDE (25MG), TRIAMTERENE (50MG)ORALCAPSULETrueAB1991-07-31TRIAMTERENE AND HYDROCHLOROTHIAZIDE
3ANDA074259_001RXTRIAMTERENE (50MG), HYDROCHLOROTHIAZIDE (25MG)ORALCAPSULEFalseAB1995-03-30TRIAMTERENE AND HYDROCHLOROTHIAZIDE
4ANDA074701_001RXTRIAMTERENE (37.5MG), HYDROCHLOROTHIAZIDE (25MG)ORALCAPSULEFalseAB1996-06-07TRIAMTERENE AND HYDROCHLOROTHIAZIDE
5ANDA074821_001RXHYDROCHLOROTHIAZIDE (25MG), TRIAMTERENE (37.5MG)ORALCAPSULEFalseAB1997-06-05TRIAMTERENE AND HYDROCHLOROTHIAZIDE
6ANDA074857_001discontinuedTRIAMTERENE (37.5MG), HYDROCHLOROTHIAZIDE (25MG)ORALCAPSULEFalse1997-09-09TRIAMTERENE AND HYDROCHLOROTHIAZIDE
7ANDA074970_001discontinuedHYDROCHLOROTHIAZIDE (25MG), TRIAMTERENE (37.5MG)ORALCAPSULEFalse1998-01-06TRIAMTERENE AND HYDROCHLOROTHIAZIDE
8ANDA075052_001RXHYDROCHLOROTHIAZIDE (25MG), TRIAMTERENE (37.5MG)ORALCAPSULEFalseAB1999-06-18TRIAMTERENE AND HYDROCHLOROTHIAZIDE
9ANDA201407_001RXTRIAMTERENE (37.5MG), HYDROCHLOROTHIAZIDE (25MG)ORALCAPSULEFalseAB2011-12-09TRIAMTERENE AND HYDROCHLOROTHIAZIDE
10NDA016042_002discontinuedTRIAMTERENE (50MG), HYDROCHLOROTHIAZIDE (25MG)ORALCAPSULEFalseDYAZIDE
11NDA016042_003RXTRIAMTERENE (37.5MG), HYDROCHLOROTHIAZIDE (25MG)ORALCAPSULETrueAB1994-03-03DYAZIDE

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
102cdbfdd-0696-417e-ac67-6fede0d9d3dd (view SPL)Triamterene and Hydrochlorothiazide Capsules, USPRx OnlyprescriptionHuman PrescriptionSt Marys Medical Park PharmacyMANUFACTURE, relabel, repack2014-04-211607600535
21a1ba6bd-e1f4-4928-a32b-a63416ce8681 (view SPL)Triamterene and Hydrochlorothiazide Capsules, USPprescriptionHuman PrescriptionState Of Florida Doh Central Pharmacyrepack2010-05-211538080803
31c1277f3-1936-40f2-8efa-4233c39f93a0 (view SPL)prescriptionHuman PrescriptionMylan Pharmaceuticals Inc.2015-01-064003782537
41d631948-6491-7270-e054-00144ff88e88 (view SPL)Triamterene and Hydrochlorothiazide Capsules, USPprescriptionHuman PrescriptionMedsource Pharmaceuticalsrepack2015-08-151458650402
521c7fb80-4f9f-41eb-bebb-eda511980284 (view SPL)Triamterene and Hydrochlorothiazide Capsules, USPprescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2010-12-011216950839
623e4b35c-9721-4af5-842a-f9fac356c662 (view SPL)Triamterene and Hydrochlorothiazide Capsules, USPRx OnlyprescriptionHuman PrescriptionRemedyrepack Inc.2013-05-151521250420
726d46abd-8d8e-4124-9e23-07436521752e (view SPL)Triamterene and Hydrochlorothiazide Capsules, USPprescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2013-01-171000636291507
8271eb9bb-77de-49f5-854e-085a909a35a8 (view SPL)Triamterene and Hydrochlorothiazide Capsules, USPprescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2012-01-2511552890725
92b9623b3-3757-43f8-ab67-47895bbc92b4 (view SPL)Triamterene and Hydrochlorothiazide Capsules, USPRx OnlyprescriptionHuman PrescriptionRemedyrepack Inc.2013-05-241521250420
102ebee624-71ee-4ebb-8bad-555f8d0dbac2 (view SPL)prescriptionHuman PrescriptionMylan Institutional Inc.2015-08-072510790935
112edaac6a-9fa2-48ba-bfae-3a79381482fb (view SPL)Triamterene and Hydrochlorothiazide Capsules, USPprescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2012-06-156548680932, 548685113
125171e219-38cb-4f4d-b33b-abbd713bf642 (view SPL)Triamterene and Hydrochlorothiazide Capsules, USP 8284021/0814 Rx OnlyprescriptionHuman PrescriptionAmerican Health PackagingREPACK2015-02-231680840840
13549ba070-55a8-4eb3-9120-d8fe99d4d5e3 (view SPL)Triamterene and Hydrochlorothiazide CapsulesprescriptionHuman PrescriptionNcs Healthcare Of Ky, Inc Dba Vangard LabsRELABEL, REPACK2012-11-152006151333
14584ddc7a-c288-4b7d-8851-b2e3a384eab9 (view SPL)Triamterene and Hydrochlorothiazide Capsules, USPprescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2013-01-171000636294112
157330f40d-b269-425b-a4e3-e7263a088fb7 (view SPL)DYAZIDE(hydrochlorothiazide/triamterene)CapsulesprescriptionHuman PrescriptionCardinal HealthREPACK2011-01-041551544510
167888c0eb-f5c9-dd04-c790-b1e8a4c6068a (view SPL)Triamterene and Hydrochlorothiazide Capsules, USPRx OnlyprescriptionHuman PrescriptionAvkare, Inc.2012-07-031422910841
1781a11c2e-5cfd-4dbd-9f8c-b50b7b2e62fc (view SPL)Triamterene and Hydrochlorothiazide Capsules, USPprescriptionHuman PrescriptionSandoz Inc2012-01-2511007812074, 007812715
18b23d4978-0d47-457a-8176-0e8c567d5dd1 (view SPL)Triamterene and Hydrochlorothiazide Capsules, USPRx OnlyprescriptionHuman PrescriptionLannett Company, Inc.ANALYSIS, LABEL, MANUFACTURE, PACK2012-07-128005271632
19c44e8537-145f-4221-b077-d26701078989 (view SPL)TRIAMTERENEandHYDROCHLOROTHIAZIDECAPSULES, USP37.5 mg/25 mgprescriptionHuman Prescription with HighlightsState Of Florida Doh Central Pharmacyrepack2010-05-211538080802
20cb2b4ca7-067e-4ee2-9550-e54ee6b5edb1 (view SPL)Triamterene and Hydrochlorothiazide Capsules, USPprescriptionHuman PrescriptionLake Erie Medical Dba Quality Care Products Llcrepack2013-07-151353560974
21e1535638-598a-4d5e-b8e1-31abe65400d2 (view SPL)prescriptionHuman PrescriptionLake Erie Medical Dba Quality Care Products Llcrelabel, repack2012-05-313834499990066
22f11598d2-87ee-4292-8631-c29c54f4dfa9 (view SPL)Triamterene and Hydrochlorothiazide Capsules, USPprescriptionHuman PrescriptionProficient Rx LpRELABEL, REPACK2015-02-011631870465
23f6eba4b6-9cd0-4c86-46a8-05a202641c89 (view SPL)DYAZIDE (hydrochlorothiazide/triamterene) CapsulesprescriptionHuman PrescriptionGlaxosmithkline Llc2012-01-2011000073650

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