FDA.reportPublic FDA data

Triamterene and Hydrochlorothiazide

Product NDC
0591-0348
11-digit product format
005910348
Labeler code
0591
Product ID
0591-0348_31975473-b876-48d4-81f4-b322137d8900
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Triamterene and Hydrochlorothiazide
Dosage form
TABLET
Route
ORAL
Labeler
Actavis Pharma, Inc.
Application
ANDA071851
Marketing category
ANDA
Marketing start
1993-09-23
Substance
HYDROCHLOROTHIAZIDE; TRIAMTERENE
Active strength
50; 75 mg/1; mg/1
Pharmacologic classes
Decreased Renal K+ Excretion [PE], Increased Diuresis [PE], Increased Diuresis [PE], Potassium-sparing Diuretic [EPC], Thiazide Diuretic [EPC], Thiazides [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Triamterene and Hydrochlorothiazide
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROCHLOROTHIAZIDE50 mg/1
TRIAMTERENE75 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0J48LPH2TH, WS821Z52LQ
Rxcui310812, 310818

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c19ec24d-2c40-4b8d-7c20-500ffa3660a1Product name320260303
1199f4b7-b537-466c-9a1c-cb09131e9f8bProduct name120251117
e1a63b6e-1877-c2c1-01a3-03ea2817aa6fProduct name320251027
b15e9aa6-d523-ca97-480e-570e0543a342Product name420251024
96816964-c075-ffa7-b7b8-d8570411a3b9Product name720250305
162cbc9d-ecc3-72ba-af9f-c76e2756ef54Product name320221207
9b303cd4-3186-2454-5706-3137e8b2dfd2Product name420221110
47fc2fe9-7afb-4be9-989d-787aaa6ad0eaProduct name120200505
b2ea36e8-564d-01b9-8552-a327d058eb0fProduct name220200203
a8e65197-7914-7acf-c7ec-914d53819b34Product name320190624
8b67f333-47d1-8464-7ce4-406d3dbb295fProduct name720190618
89a57420-ab44-5323-14f9-595159145f9bProduct name220190612
c27b049d-3258-48cf-ebe5-08c236ae78e2Product name320190610
00fc2cf9-672f-3e0b-6afa-43cbc864d058Product name420180613
15b375b1-89c7-9594-80df-5a8c8864aee0Product name320180108
a7349398-661d-d9fc-46df-7e128bbd61d9Product name520171113
1bdb87cf-9b1f-6a51-5eb7-d182aaffaa3dProduct name220170719
e0eeb018-194e-4b70-a57d-bac47a97b8eaProduct name120160825
55bffd21-17e1-ff02-2e8f-1f9a532b9502Product name220150320
ea069444-e874-4c28-833f-d2f52734ef4dProduct name120150206
041df61b-f8b6-48a6-7b67-411e1412678bProduct name120140508
0ad8bdca-888e-00da-648b-6a4de854a167Product name120140508
433a3439-b8f3-d13a-d2c8-9b221d628d60Product name120140508
59212689-39e5-a976-6d21-882d76d8079aProduct name120140508
7613b1a5-acb6-4e5e-6048-c44deeeb1212Product name120140508
78637fb0-95c8-441f-e4b4-db1274b6f956Product name120140508
df89bd47-2db4-d593-ab37-d11953fd5536Product name120140508
f151007d-265d-9fbe-857d-1d44f1cb76baProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0591-0348-01Triamterene and Hydrochlorothiazide100 in 1 BOTTLE, PLASTICTABLET10017
0591-0348-05Triamterene and Hydrochlorothiazide500 in 1 BOTTLE, PLASTICTABLET50017
0591-0348-10Triamterene and Hydrochlorothiazide1000 in 1 BOTTLE, PLASTICTABLET100017

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0591-0348-01EA - Each0591-03482f34148b-e98b-43b7-a8c4-06e62a0d28d612012-07-24
0591-0348-05EA - Each0591-034896d4bf9b-6d62-40bc-a901-4238716a168f12012-07-24
0591-0348-10EA - Each0591-03487171935e-ba9e-4ef9-a311-c65bd532dfec12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROCHLOROTHIAZIDEACTIVE INGREDIENT0J48LPH2THTRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [WATSON LABORATORIES, INC.]9
TRIAMTERENEACTIVE INGREDIENTWS821Z52LQTRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [WATSON LABORATORIES, INC.]9
HYDROCHLOROTHIAZIDEACTIVE MOIETY0J48LPH2THTRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [WATSON LABORATORIES, INC.]9
TRIAMTERENEACTIVE MOIETYWS821Z52LQTRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [WATSON LABORATORIES, INC.]9
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKTRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [WATSON LABORATORIES, INC.]9
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [WATSON LABORATORIES, INC.]9
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKTRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [WATSON LABORATORIES, INC.]9
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [WATSON LABORATORIES, INC.]9
POLACRILIN POTASSIUMINACTIVE INGREDIENT0BZ5A00FQUTRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [WATSON LABORATORIES, INC.]9
POLYETHYLENE GLYCOL 8000INACTIVE INGREDIENTQ662QK8M3BTRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [WATSON LABORATORIES, INC.]9
POVIDONEINACTIVE INGREDIENTFZ989GH94ETRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [WATSON LABORATORIES, INC.]9
HYDROCHLOROTHIAZIDEACTIVE INGREDIENT0J48LPH2THTRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [BRYANT RANCH PREPACK]3
HYDROCHLOROTHIAZIDEACTIVE INGREDIENT0J48LPH2THTRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [PD-RX PHARMACEUTICALS, INC.]3
TRIAMTERENEACTIVE INGREDIENTWS821Z52LQTRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [BRYANT RANCH PREPACK]3
TRIAMTERENEACTIVE INGREDIENTWS821Z52LQTRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [PD-RX PHARMACEUTICALS, INC.]3
HYDROCHLOROTHIAZIDEACTIVE MOIETY0J48LPH2THTRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [BRYANT RANCH PREPACK]3
HYDROCHLOROTHIAZIDEACTIVE MOIETY0J48LPH2THTRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [PD-RX PHARMACEUTICALS, INC.]3
TRIAMTERENEACTIVE MOIETYWS821Z52LQTRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [BRYANT RANCH PREPACK]3
TRIAMTERENEACTIVE MOIETYWS821Z52LQTRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [PD-RX PHARMACEUTICALS, INC.]3
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKTRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [BRYANT RANCH PREPACK]3
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKTRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [PD-RX PHARMACEUTICALS, INC.]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [BRYANT RANCH PREPACK]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [PD-RX PHARMACEUTICALS, INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [PD-RX PHARMACEUTICALS, INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [BRYANT RANCH PREPACK]3
POLACRILIN POTASSIUMINACTIVE INGREDIENT0BZ5A00FQUTRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [PD-RX PHARMACEUTICALS, INC.]3
POLACRILIN POTASSIUMINACTIVE INGREDIENT0BZ5A00FQUTRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [BRYANT RANCH PREPACK]3
POLYETHYLENE GLYCOL 8000INACTIVE INGREDIENTQ662QK8M3BTRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [BRYANT RANCH PREPACK]3
POLYETHYLENE GLYCOL 8000INACTIVE INGREDIENTQ662QK8M3BTRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [PD-RX PHARMACEUTICALS, INC.]3
POVIDONEINACTIVE INGREDIENTFZ989GH94ETRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [PD-RX PHARMACEUTICALS, INC.]3
POVIDONESINACTIVE INGREDIENTFZ989GH94ETRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [BRYANT RANCH PREPACK]3
HYDROCHLOROTHIAZIDEACTIVE INGREDIENT0J48LPH2THTRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [BLENHEIM PHARMACAL, INC.]1
HYDROCHLOROTHIAZIDEACTIVE INGREDIENT0J48LPH2THTRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [NORTHWIND PHARMACEUTICALS, LLC]1
TRIAMTERENEACTIVE INGREDIENTWS821Z52LQTRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [BLENHEIM PHARMACAL, INC.]1
TRIAMTERENEACTIVE INGREDIENTWS821Z52LQTRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [NORTHWIND PHARMACEUTICALS, LLC]1
HYDROCHLOROTHIAZIDEACTIVE MOIETY0J48LPH2THTRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [BLENHEIM PHARMACAL, INC.]1
HYDROCHLOROTHIAZIDEACTIVE MOIETY0J48LPH2THTRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [NORTHWIND PHARMACEUTICALS, LLC]1
TRIAMTERENEACTIVE MOIETYWS821Z52LQTRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [NORTHWIND PHARMACEUTICALS, LLC]1
TRIAMTERENEACTIVE MOIETYWS821Z52LQTRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [BLENHEIM PHARMACAL, INC.]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKTRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [BLENHEIM PHARMACAL, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [BLENHEIM PHARMACAL, INC.]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKTRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [BLENHEIM PHARMACAL, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [BLENHEIM PHARMACAL, INC.]1
POLACRILIN POTASSIUMINACTIVE INGREDIENT0BZ5A00FQUTRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [BLENHEIM PHARMACAL, INC.]1
POLYETHYLENE GLYCOL 8000INACTIVE INGREDIENTQ662QK8M3BTRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [BLENHEIM PHARMACAL, INC.]1
POVIDONEINACTIVE INGREDIENTFZ989GH94ETRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [BLENHEIM PHARMACAL, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0591-0348TRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [ACTAVIS PHARMA, INC.]17Current NDC, Legacy NDC, 3 package rows20241212_abf2fe45-8b69-4d3c-981e-289c0aa3e98b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310818triamterene 75 MG / hydroCHLOROthiazide 50 MG Oral TabletPSN860bed38-26f2-49bb-9dba-8928cec3c42c21
310818hydrochlorothiazide 50 MG / triamterene 75 MG Oral TabletSCD860bed38-26f2-49bb-9dba-8928cec3c42c21
310818HCTZ 50 MG / triamterene 75 MG Oral TabletSY860bed38-26f2-49bb-9dba-8928cec3c42c21
310812triamterene 37.5 MG / hydroCHLOROthiazide 25 MG Oral TabletPSNabf2fe45-8b69-4d3c-981e-289c0aa3e98b17
310818triamterene 75 MG / hydroCHLOROthiazide 50 MG Oral TabletPSNabf2fe45-8b69-4d3c-981e-289c0aa3e98b17
310812hydrochlorothiazide 25 MG / triamterene 37.5 MG Oral TabletSCDabf2fe45-8b69-4d3c-981e-289c0aa3e98b17
310818hydrochlorothiazide 50 MG / triamterene 75 MG Oral TabletSCDabf2fe45-8b69-4d3c-981e-289c0aa3e98b17
310812HCTZ 25 MG / triamterene 37.5 MG Oral TabletSYabf2fe45-8b69-4d3c-981e-289c0aa3e98b17
310818HCTZ 50 MG / triamterene 75 MG Oral TabletSYabf2fe45-8b69-4d3c-981e-289c0aa3e98b17
310818triamterene 75 MG / hydroCHLOROthiazide 50 MG Oral TabletPSN4c74bc01-1065-79f0-f9c4-044ead38a55d12
310818hydrochlorothiazide 50 MG / triamterene 75 MG Oral TabletSCD4c74bc01-1065-79f0-f9c4-044ead38a55d12
310818HCTZ 50 MG / triamterene 75 MG Oral TabletSY4c74bc01-1065-79f0-f9c4-044ead38a55d12
310818triamterene 75 MG / hydroCHLOROthiazide 50 MG Oral TabletPSN0eaf3aa9-7544-4717-944b-ec66af80770e11
310818hydrochlorothiazide 50 MG / triamterene 75 MG Oral TabletSCD0eaf3aa9-7544-4717-944b-ec66af80770e11
310818HCTZ 50 MG / triamterene 75 MG Oral TabletSY0eaf3aa9-7544-4717-944b-ec66af80770e11
310818triamterene 75 MG / hydroCHLOROthiazide 50 MG Oral TabletPSN7e7cb50d-c984-5c01-e053-2a91aa0a68a54
310818hydrochlorothiazide 50 MG / triamterene 75 MG Oral TabletSCD7e7cb50d-c984-5c01-e053-2a91aa0a68a54
310818HCTZ 50 MG / triamterene 75 MG Oral TabletSY7e7cb50d-c984-5c01-e053-2a91aa0a68a54
310818triamterene 75 MG / hydroCHLOROthiazide 50 MG Oral TabletPSNada10dd4-72e2-13b5-e053-2a95a90a8cfd3
310818triamterene 75 MG / hydroCHLOROthiazide 50 MG Oral TabletPSNd7013ec2-019e-4e6f-832f-08e27019f9173
310818hydrochlorothiazide 50 MG / triamterene 75 MG Oral TabletSCDada10dd4-72e2-13b5-e053-2a95a90a8cfd3
310818hydrochlorothiazide 50 MG / triamterene 75 MG Oral TabletSCDd7013ec2-019e-4e6f-832f-08e27019f9173
310818HCTZ 50 MG / triamterene 75 MG Oral TabletSYada10dd4-72e2-13b5-e053-2a95a90a8cfd3
310818HCTZ 50 MG / triamterene 75 MG Oral TabletSYd7013ec2-019e-4e6f-832f-08e27019f9173
310812triamterene 37.5 MG / hydroCHLOROthiazide 25 MG Oral TabletPSN11a76fc1-5a1e-0509-e054-00144ff88e881
310818triamterene 75 MG / hydroCHLOROthiazide 50 MG Oral TabletPSN11a76fc1-5a1e-0509-e054-00144ff88e881
310812hydrochlorothiazide 25 MG / triamterene 37.5 MG Oral TabletSCD11a76fc1-5a1e-0509-e054-00144ff88e881
310818hydrochlorothiazide 50 MG / triamterene 75 MG Oral TabletSCD11a76fc1-5a1e-0509-e054-00144ff88e881
310812HCTZ 25 MG / triamterene 37.5 MG Oral TabletSY11a76fc1-5a1e-0509-e054-00144ff88e881
310818HCTZ 50 MG / triamterene 75 MG Oral TabletSY11a76fc1-5a1e-0509-e054-00144ff88e881

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0591-0348-000059103480024900 TABLET in 1 BAG (0591-0348-00)24900 tablet23-SEP-9330-APR-28Historical
0591-0348-0100591034801100 TABLET in 1 BOTTLE, PLASTIC (0591-0348-01) 100 tablet1993-09-230000-00-00NoNoCurrent
0591-0348-0500591034805500 TABLET in 1 BOTTLE, PLASTIC (0591-0348-05) 500 tablet1993-09-230000-00-00NoNoCurrent
0591-0348-10005910348101000 TABLET in 1 BOTTLE, PLASTIC (0591-0348-10) 1000 tablet1993-09-230000-00-00NoNoCurrent