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 17 of 30 · 600 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
VALSARTAN AND HYDROCHLOROTHIAZIDEVALSARTAN AND HYDROCHLOROTHIAZIDEBryant Ranch Prepack46addda8-f798-4207-b8fb-ea75c5903a362025-05-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDEOLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEMacleods Pharmaceuticals Limited03ff0f7e-6aa1-4c38-8c9a-5f1c6a56c7472025-05-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Candesartan Cilexetil and HydrochlorothiazideCANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDEMacleods Pharmaceuticals Limited76630807-9717-44be-946d-756038cf677e2025-05-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
HydrochlorothiazideHYDROCHLOROTHIAZIDEA-S Medication Solutions02a481cb-ad80-41bb-82d3-c237b00ed8d72025-05-15Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDEREMEDYREPACK INC.1570f1ad-8372-477f-89c3-8c9ce01e27d12025-05-07Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
HydrochlorothiazideHYDROCHLOROTHIAZIDEPreferred Pharmaceuticals Inc.82ad0fdf-5d47-4c2d-883b-f28b2d3fb6b02025-04-29Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
HydrochlorothiazideHYDROCHLOROTHIAZIDENuCare Pharmaceuticals,Inc.fea5a353-9b13-9b87-e053-6394a90a627d2025-04-25Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDEOLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDENorthStar RxLLC364af4fe-cde8-466f-b56f-d93d532b56f52025-04-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDEAMLODIPINE BESYLATE VALSARTAN HYDROCHLOROTHIAZIDEStrides Pharma Science Limited9b76e441-e6a5-4036-8276-b7788ade5c442025-04-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
ZestoreticLISINOPRIL AND HYDROCHLOROTHIAZIDEAlmatica Pharma Inc.0d3a966f-f937-05a8-a90f-5aa52ebbd6132025-03-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Triamterene and HydrochlorothiazideTRIAMTERENE AND HYDROCHLOROTHIAZIDEMacleods Pharmaceuticals Limitede05e3314-5520-4bbd-b7f0-623afd9ba5692025-03-04Warnings, Adverse reactionsExact identifier
unii: WS821Z52LQ
unii: 0J48LPH2TH
YVTYVT MICRODERMABRASION FACIAL SCRUBYVTYVT MICRODERMABRASION FACIAL SCRUBBeijing JUNGE Technology Co., Ltd.2f30fc45-42e2-c766-e063-6394a90a8d682025-02-28WarningsExact identifier
unii: OP1R32D61U
HydrochlorothiazideHYDROCHLOROTHIAZIDENuCare Pharmaceuticals,Inc.852c6f3f-d3f5-0d99-e053-2991aa0aa9c32025-02-21Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
LISINOPRIL and HYDROCHLOROTHIAZIDELISINOPRIL AND HYDROCHLOROTHIAZIDEGSMS, Incorporatedd02a0d38-676a-4e0f-9aa2-0a6c56cd73612025-02-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Walgreens Soothing Eye Relief Lubricant Eye DropsPOLYVINYL ALCOHOL, POVIDONEWalgreens Co.29b7387b-ad65-3a11-e063-6394a90a6a152025-02-14WarningsExact identifier
unii: FZ989GH94E
Losartan Potassium and HydrochlorothiazideLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEBryant Ranch Prepacke0f63126-6890-48bf-9c25-444dc5974ecd2025-02-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Losartan Potassium and HydrochlorothiazideLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDENuCare Pharmaceuticals,Inc.5e35e3b9-7d79-b32a-e053-2991aa0ae9c02025-02-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
HydrochlorothiazideHYDROCHLOROTHIAZIDEProficient Rx LP4c1a2fb9-133d-4bd5-a336-e47d54f22c972025-02-01Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Losartan Potassium and HydrochlorothiazideLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEBryant Ranch Prepack8b36fa56-4274-4fc6-bdba-ca7a399b2b212025-01-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
HydrochlorothiazideHYDROCHLOROTHIAZIDERedpharm drugfa1c0b92-4360-bcfd-e053-6394a90a955a2025-01-23Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH

Reported adverse events (FAERS/openFDA)#

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