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 14 of 30 · 600 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HydrochlorothiazideHYDROCHLOROTHIAZIDEPD-Rx Pharmaceuticals, Inc.89d367b1-de04-4970-9967-27a1c7711c0f2025-10-01Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
HydrochlorothiazideHYDROCHLOROTHIAZIDEPD-Rx Pharmaceuticals, Inc.1dc47186-3ecf-456f-b6d6-ba0f75c2504b2025-10-01Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Triamterene and HydrochlorothiazideTRIAMTERENE AND HYDROCHLOROTHIAZIDEPreferred Pharmaceuticals Inc.1fff8245-2b65-4ab1-aaa2-6bbbc6ac5fe82025-10-01Boxed warning, Adverse reactionsExact identifier
unii: WS821Z52LQ
unii: 0J48LPH2TH
Triamterene and HydrochlorothiazideTRIAMTERENE AND HYDROCHLOROTHIAZIDEPreferred Pharmaceuticals Inc.5fc69fbf-c2d2-41ef-99bb-62a76ef74db22025-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 310818
unii: WS821Z52LQ
unii: 0J48LPH2TH
Triamterene and HydrochlorothiazideTRIAMTERENE AND HYDROCHLOROTHIAZIDEBluePoint Laboratories4f44fb73-7f61-4623-ae89-61abd8e945ab2025-09-30Warnings, Adverse reactionsExact identifier
rxcui: 310818
rxcui: 310812
unii: WS821Z52LQ
unii: 0J48LPH2TH
olmesartan medoxomil-hydrochlorothiazideOLMESARTAN MEDOXOMIL-HYDROCHLOROTHIAZIDENovadoz Pharmaceuticals LLCc8197eea-e990-4c0e-bc2d-f080bac8de172025-09-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Losartan Potassium and HydrochlorothiazideLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEPD-Rx Pharmaceuticals, Inc.dcb39c6b-430d-4b3d-ba6f-5bf1efe116aa2025-09-25Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Bisoprolol Fumarate and HydrochlorothiazideBISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDEMarlex Pharmaceuticals, Inc.df881501-42ae-624a-e053-2995a90ab2a02025-09-23Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Losartan Potassium and HydrochlorothiazideLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEAlembic Pharmaceuticals Limitedbbf7e20d-dfc2-4115-8788-c0cac15a11482025-09-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Triamterene and HydrochlorothiazideTRIAMTERENE AND HYDROCHLOROTHIAZIDEBryant Ranch Prepack5ba2c08b-5ce5-4967-bc3b-2c73df9865af2025-09-12Warnings, Adverse reactionsExact identifier
rxcui: 310818
unii: WS821Z52LQ
unii: 0J48LPH2TH
Eyes Irritation ReliefPOLYVINYL ALCOHOL AND POVIDONE AND TETRAHYDROZOLINE HYDROCHLORIDECARDINAL HEALTH 110, LLC. DBA LEADERbd2608c6-ffdf-352a-e053-2995a90a26a82025-09-12WarningsExact identifier
unii: FZ989GH94E
Triamterene and HydrochlorothiazideTRIAMTERENE AND HYDROCHLOROTHIAZIDEBryant Ranch Prepackec6dce85-5c0b-475c-af0b-cbbc034f698f2025-09-12Warnings, Adverse reactionsExact identifier
rxcui: 310812
unii: WS821Z52LQ
unii: 0J48LPH2TH
Losartan Potassium and HydrochlorothiazideLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEBryant Ranch Prepack60f3f17d-fd28-406d-97ca-9f01f5f1c72c2025-09-11Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Losartan Potassium and HydrochlorothiazideLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDENorthStar Rx LLC25318baf-9c2f-458f-b9ea-f52dabca49af2025-09-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Bisoprolol Fumarate and HydrochlorothiazideBISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDEA-S Medication Solutions6b7f96c3-daf4-4029-a96b-baa37add0edb2025-09-05Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Losartan Potassium and HydrochlorothiazideLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEBryant Ranch Prepack0e015b9a-0ac1-4ec3-bbe7-7a672d30e1f42025-09-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Losartan Potassium and HydrochlorothiazideLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEBryant Ranch Prepack8d56b5db-e72d-4f09-aed4-09e65a27e9ff2025-09-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Irbesartan and HydrochlorothiazideIRBESARTAN AND HYDROCHLOROTHIAZIDEMacleods Pharmaceuticals Limited1898f438-4571-4aab-ae06-9bf1aabf04862025-09-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Losartan Potassium and HydrochlorothiazideLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEProficient Rx LPbe81ba65-c434-4287-97d3-cd11d60316362025-09-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Losartan Potassium and HydrochlorothiazideLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEAvKAREe78b2195-a2da-3d03-e053-2a95a90a7d562025-08-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH

Reported adverse events (FAERS/openFDA)#

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