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 24 of 30 · 600 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sunmark Eye Drops Advanced Moisturizer/LubricantDEXTRAN, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINEStrategic Sourcing Services LLC0daa4e39-0447-44b6-a7d7-370b12bf94512023-12-23WarningsExact identifier
unii: FZ989GH94E
Meijer Artificial TearsPOLYVINYL ALCOHOL, POVIDONEMeijer Distribution, Inc.9feb3eec-a36f-8fc7-e053-2a95a90adcd32023-12-22WarningsExact identifier
unii: FZ989GH94E
Meijer Advanced Redness and Irritation ReliefDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCIMeijer Distribution, Inc.9fea6d7a-a2cd-d26e-e053-2995a90a15f82023-12-22WarningsExact identifier
unii: FZ989GH94E
Walgreens Eye Drops Advanced Relief 15mLDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCIWalgreen Company949f5560-fba7-2da8-e053-2995a90a23c22023-12-20WarningsExact identifier
unii: FZ989GH94E
Signature Care Eye Drops Advanced ReliefDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLBetter Living Brands LLC5d7228ce-f108-4cc2-9aec-8b4548c3a1552023-12-20WarningsExact identifier
unii: FZ989GH94E
Kroger Eye Drops Advanced ReliefDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDEKroger Companyf7ad77fc-d890-25b9-e053-6394a90a2b122023-12-20WarningsExact identifier
unii: FZ989GH94E
Equaline Advanced Relief Eye DropsDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDEUnited Natural Foods, Inc.f7602789-179a-edfc-e053-6294a90a08442023-12-20WarningsExact identifier
unii: FZ989GH94E
Topcare Health Artificial TearsPOLYVINYL ALCOHOL, POVIDONETopco Associates LLC9c614c0e-5862-682f-e053-2a95a90abc092023-12-20WarningsExact identifier
unii: FZ989GH94E
TopCare Health Advanced Moisturizing Plus Redness ReliefDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLTopco Associates LLC9c6193a6-d822-1b27-e053-2995a90ab3cf2023-12-20WarningsExact identifier
unii: FZ989GH94E
HEB Advanced Eye DropsDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDEHEB Grocery Company, LPf76281d6-3aea-349b-e053-6394a90afca22023-12-20WarningsExact identifier
unii: FZ989GH94E
Amlodipine, Valsartan and HydrochlorothiazideAMLODIPINE, VALSARTAN AND HYDROCHLOROTHIAZIDELupin Pharmaceuticals, Inc.5dbb43b1-3ea4-4fa5-a9aa-95d869ae65fe2023-12-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Quinapril and HydrochlorothiazideQUINAPRIL AND HYDROCHLOROTHIAZIDEChartwell RX, LLC2eae533f-d0af-47e8-a1f2-94bc8cc89b5a2023-12-11Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Triamterene and HydrochlorothiazideTRIAMTERENE AND HYDROCHLOROTHIAZIDEA-S Medication Solutions0eaf3aa9-7544-4717-944b-ec66af80770e2023-12-10Warnings, Adverse reactionsExact identifier
application number: ANDA071851
rxcui: 310818
unii: WS821Z52LQ
unii: 0J48LPH2TH
Losartan Potassium and HydrochlorothiazideLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEA-S Medication Solutionsa4aa7f77-c98d-4b70-84bb-e16a06fc79522023-12-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
olmesartan medoxomil / amlodipine besylate / hydrochlorothiazideOLMESARTAN MEDOXOMIL / AMLODIPINE BESYLATE / HYDROCHLOROTHIAZIDEBryant Ranch Prepack900024f4-23d6-4505-81db-4f643e12858c2023-12-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Losartan Potassium and HydrochlorothiazideLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEA-S Medication Solutions88fabecc-6e53-464b-9659-12b2472c89ce2023-12-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Lisinopril and HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETSA-S Medication Solutions3372e46d-8f18-44fd-a9c8-3d8a45d9acdc2023-12-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Lisinopril and HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETSA-S Medication Solutionsed019adb-0a18-4aba-9b09-a0c966322d962023-12-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Good Neighbor Pharmacy Artifical Tears Lubricant Eye DropsPOLYVINYL ALCOHOL, POVIDONEProficient Rx LP73e12596-6dd5-4cd2-83ed-992e1211b4b82023-12-01WarningsExact identifier
unii: FZ989GH94E
Valsartan and HydrochlorothiazideVALSARTAN AND HYDROCHLOROTHIAZIDELupin Pharmaceuticals, Inc.d74a85de-5917-401a-b92d-6a95da5d30a62023-11-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH

Reported adverse events (FAERS/openFDA)#

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