FDA.reportPublic FDA data

NDC 52544-348 - Triamterene and Hydrochlorothiazide

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
52544-348
Package NDCs from labels
52544-348-30, 52544-348-01, 52544-348-05, 52544-348-10
Manufacturer
State of Florida DOH Central Pharmacy
Effective date
2010-06-07
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Triamterene and Hydrochlorothiazide - State of Florida DOH Central PharmacyState of Florida DOH Central Pharmacy2010-06-07HUMAN PRESCRIPTION DRUG LABEL
Triamterene and Hydrochlorothiazide Tablets USP Rx onlyWatson Laboratories, Inc.2008-01-24HUMAN PRESCRIPTION DRUG LABELING

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52544-348-01Triamterene and Hydrochlorothiazide100 in 1 BOTTLETABLET1001
52544-348-05Triamterene and Hydrochlorothiazide500 in 1 BOTTLETABLET5001
52544-348-10Triamterene and Hydrochlorothiazide1000 in 1 BOTTLETABLET10001
52544-348-30Triamterene and Hydrochlorothiazide30 in 1 BOTTLETABLET301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52544-348TRIAMTERENE AND HYDROCHLOROTHIAZIDE (TRIAMTERENE AND HYDROCHLOROTHIAZIDE) TABLET [WATSON LABORATORIES, INC.]14 package rows20080222_AB816790-A45B-406D-8919-EDFD2A11E9A9.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROCHLOROTHIAZIDEACTIVE INGREDIENT0J48LPH2THTRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
HydrochlorothiazideACTIVE INGREDIENT0J48LPH2THTRIAMTERENE AND HYDROCHLOROTHIAZIDE (TRIAMTERENE AND HYDROCHLOROTHIAZIDE) TABLET [WATSON LABORATORIES, INC.]1
TRIAMTERENEACTIVE INGREDIENTWS821Z52LQTRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
TriamtereneACTIVE INGREDIENTWS821Z52LQTRIAMTERENE AND HYDROCHLOROTHIAZIDE (TRIAMTERENE AND HYDROCHLOROTHIAZIDE) TABLET [WATSON LABORATORIES, INC.]1
HYDROCHLOROTHIAZIDEACTIVE MOIETY0J48LPH2THTRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
HydrochlorothiazideACTIVE MOIETY0J48LPH2THTRIAMTERENE AND HYDROCHLOROTHIAZIDE (TRIAMTERENE AND HYDROCHLOROTHIAZIDE) TABLET [WATSON LABORATORIES, INC.]1
TriamtereneACTIVE MOIETYWS821Z52LQTRIAMTERENE AND HYDROCHLOROTHIAZIDE (TRIAMTERENE AND HYDROCHLOROTHIAZIDE) TABLET [WATSON LABORATORIES, INC.]1
TRIAMTERENEACTIVE MOIETYWS821Z52LQTRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKTRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
Anhydrous lactoseINACTIVE INGREDIENT3SY5LH9PMKTRIAMTERENE AND HYDROCHLOROTHIAZIDE (TRIAMTERENE AND HYDROCHLOROTHIAZIDE) TABLET [WATSON LABORATORIES, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
FD & C Blue #2INACTIVE INGREDIENTTRIAMTERENE AND HYDROCHLOROTHIAZIDE (TRIAMTERENE AND HYDROCHLOROTHIAZIDE) TABLET [WATSON LABORATORIES, INC.]1
Magnesium stearateINACTIVE INGREDIENT70097M6I30TRIAMTERENE AND HYDROCHLOROTHIAZIDE (TRIAMTERENE AND HYDROCHLOROTHIAZIDE) TABLET [WATSON LABORATORIES, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
Microcrystalline celluloseINACTIVE INGREDIENTTRIAMTERENE AND HYDROCHLOROTHIAZIDE (TRIAMTERENE AND HYDROCHLOROTHIAZIDE) TABLET [WATSON LABORATORIES, INC.]1
POLACRILIN POTASSIUMINACTIVE INGREDIENT0BZ5A00FQUTRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
Polacrillin potassiumINACTIVE INGREDIENTTRIAMTERENE AND HYDROCHLOROTHIAZIDE (TRIAMTERENE AND HYDROCHLOROTHIAZIDE) TABLET [WATSON LABORATORIES, INC.]1
Polyethylene glycol 8000INACTIVE INGREDIENTTRIAMTERENE AND HYDROCHLOROTHIAZIDE (TRIAMTERENE AND HYDROCHLOROTHIAZIDE) TABLET [WATSON LABORATORIES, INC.]1
POLYETHYLENE GLYCOL 8000INACTIVE INGREDIENTQ662QK8M3BTRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
PovidoneINACTIVE INGREDIENTTRIAMTERENE AND HYDROCHLOROTHIAZIDE (TRIAMTERENE AND HYDROCHLOROTHIAZIDE) TABLET [WATSON LABORATORIES, INC.]1
POVIDONEINACTIVE INGREDIENTFZ989GH94ETRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 13 of 30 · 600 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HydrochlorothiazideHYDROCHLOROTHIAZIDEPD-Rx Pharmaceuticals, Inc.c182b6a9-1a31-45ee-9cea-a557c99f5db72025-11-20Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
HydrochlorothiazideHYDROCHLOROTHIAZIDEA-S Medication Solutionsef8a7dee-3704-4c62-8981-f8adfb47f5d02025-11-20Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDEA-S Medication Solutions67c48f86-f412-4957-8e15-aec89e07d2952025-11-18Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDEA-S Medication Solutions42542233-b992-4953-87ec-5095b196d61b2025-11-18Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Lisinopril and HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDEA-S Medication Solutionscd62e287-b648-459a-9414-621686c6b6072025-11-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Irbesartan and HydrochlorothiazideIRBESARTAN AND HYDROCHLOROTHIAZIDEBryant Ranch Prepack46d77ed8-ece2-4f51-b1a4-4a440e2dce2d2025-11-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Lisinopril and HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDEA-S Medication Solutions316e9226-e63e-466d-8143-f1edc7288fca2025-11-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEOLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEAccord Healthcare Inc.d858a6de-dda5-4bcd-a255-5723d01d896f2025-10-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
LACRIFRESH HYDRAPFGLYCERIN, POVIDONEAVIZOR, S.A.41bbd23e-0ec8-eb18-e063-6294a90a46d12025-10-27WarningsExact identifier
unii: FZ989GH94E
LACRIFRESH HYDRAMAXPFGLYCERIN, POVIDONEAVIZOR, S.A.41be1604-89b4-7ec3-e063-6294a90a33312025-10-27WarningsExact identifier
unii: FZ989GH94E
StyePOLYVINYL ALCOHOL AND POVIDONEMedtech Products Inc.60c11d3d-df20-4d1c-b425-49a84fecea302025-10-23WarningsExact identifier
unii: FZ989GH94E
losartan potassium and hydrochlorothiazideLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEBryant Ranch Prepack68a99bb3-69ad-42e2-9d50-390f757446712025-10-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
iVIZIA Dry EyePOVIDONEThea Pharma Inc.1ef73cb1-da48-a713-e063-6294a90afa9d2025-10-20WarningsExact identifier
unii: FZ989GH94E
Triamterene and HydrochlorothiazideTRIAMTERENE AND HYDROCHLOROTHIAZIDEPD-Rx Pharmaceuticals, Inc.e505484d-b600-4d13-a4b9-278dc4a2e73a2025-10-20Warnings, Adverse reactionsExact identifier
rxcui: 310812
unii: WS821Z52LQ
unii: 0J48LPH2TH
Triamterene and HydrochlorothiazideTRIAMTERENE AND HYDROCHLOROTHIAZIDEPD-Rx Pharmaceuticals, Inc.860bed38-26f2-49bb-9dba-8928cec3c42c2025-10-20Warnings, Adverse reactionsExact identifier
application number: ANDA071851
rxcui: 310818
unii: WS821Z52LQ
unii: 0J48LPH2TH
Triamterene and HydrochlorothiazideTRIAMTERENE AND HYDROCHLOROTHIAZIDEBryant Ranch Prepack02752dae-30b7-4726-b22b-985b330a20602025-10-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 310812
unii: WS821Z52LQ
unii: 0J48LPH2TH
AvalideIRBESARTAN AND HYDROCHLOROTHIAZIDESanofi-Aventis U.S. LLC0d91895e-c869-4b33-9b83-d55c1ad6317e2025-10-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
VALSARTAN AND HYDROCHLOROTHIAZIDEVALSARTAN AND HYDROCHLOROTHIAZIDEPreferred Pharmaceuticals Inc.d09747f0-029e-4090-949b-e939948249b52025-10-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Losartan Potassium and HydrochlorothiazideLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEA-S Medication Solutions0a34f28c-20e6-4f34-9c4a-70fb258aa3002025-10-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Losartan Potassium and HydrochlorothiazideLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEA-S Medication Solutions8a3e5be8-0a4b-48a0-817f-6e3c7674109d2025-10-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.