FDA.reportPublic FDA data

NDC 68071-4963-01 - 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
68071-4963
Requested NDC
68071-4963-01
Package NDCs from labels
68071-4963-9, 68071-4963-1, 68071-4963-01
Manufacturer
NuCare Pharmaceuticals,Inc.
Effective date
2025-06-27
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
HYDROCHLOROTHIAZIDE TABLETS USP 2083 2089 Rx onlyNuCare Pharmaceuticals,Inc.2025-06-27HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2023-02-02HYDROCHLOROTHIAZIDE TABLETS USP 2083 2089 Rx only
2023-01-30HYDROCHLOROTHIAZIDE TABLETS USP 2083 2089 Rx only
2021-02-18HYDROCHLOROTHIAZIDE TABLETS USP 2083 2089 Rx only
2021-01-29HYDROCHLOROTHIAZIDE TABLETS USP 2083 2089 Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-4963-1Hydrochlorothiazide20 in 1 BOTTLETABLET206
68071-4963-9Hydrochlorothiazide90 in 1 BOTTLETABLET906

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-4963HYDROCHLOROTHIAZIDE TABLET [NUCARE PHARMACEUTICALS,INC.]5Current NDC, Legacy NDC, 2 package rows20250105_8d5a9196-5f1d-2d83-e053-2a95a90a6036.zip

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 28 · 558 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
telmisartan and hydrochlorothiazideTELMISARTAN AND HYDROCHLOROTHIAZIDELifestar Pharma LLC0c1bd0f4-034e-486c-ae46-2855c8c9ebda2025-08-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Losartan Potassium and HydrochlorothiazideLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEPD-Rx Pharmaceuticals, Inc.473d90ed-e262-4ec6-975b-494d89f1ad702025-08-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
HydrochlorothiazideHYDROCHLOROTHIAZIDEOxford Pharmaceuticals, LLCafbb9a0e-c22f-4133-8015-b4b2ab4d32e62025-08-18Warnings, Adverse reactionsExact identifier
rxcui: 310798
unii: 0J48LPH2TH
losartan potassium and hydrochlorothiazideLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEBryant Ranch Prepackf9cfb39e-4367-40a0-86ee-138645aace562025-08-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
losartan potassium and hydrochlorothiazideLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEBryant Ranch Prepack3c873a8c-b21e-448e-87f3-333419739cdd2025-08-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Losartan Potassium and HydrochlorothiazideLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEAurobindo Pharma Limiteddc177d6c-c754-4379-8c2f-1cf6f52f950a2025-08-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Olmesartan medoxomil Amlodipine and HydrochlorothiazideOLMESARTAN MEDOXOMIL AMLODIPINE AND HYDROCHLOROTHIAZIDEMacleods Pharmaceuticals Limited52c013e1-8c31-4bed-9241-e7845873ebe82025-08-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Losartan Potassium and HydrochlorothiazideLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEPreferred Pharmaceuticals Inc.46cf633d-70a5-4d3b-b349-ad74c23ddace2025-08-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Losartan Potassium and HydrochlorothiazideLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEPreferred Pharmaceuticals Inc.24ee299f-4466-45d4-9013-17791e1998bb2025-08-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
VALSARTAN AND HYDROCHLOROTHIAZIDEVALSARTAN AND HYDROCHLOROTHIAZIDESolco Healthcare US, LLCf8b0a8ab-4549-4553-a127-bf2c0291a4b12025-07-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Triamterene and HydrochlorothiazideTRIAMTERENE AND HYDROCHLOROTHIAZIDENuCare Pharmaceuticals, Inc.3b3c92b1-bec3-2768-e063-6394a90a9af82025-07-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Lisinopril and HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETSSolco Healthcare LLC96922ddc-e87f-4670-b22e-0ffd0d8f66e12025-07-25Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Spironolactone and HydrochlorothiazideSPIRONOLACTONE AND HYDROCHLOROTHIAZIDEMylan Institutional Inc.f2a4fbc0-650b-440d-9555-c1720fe0fe352025-07-22Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Losartan potassium and HydrochlorothiazideLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEMacleods Pharmaceuticals Limiteda04b5622-2c49-4d61-92b1-5dc523af7a242025-07-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Schuessler Tissue Salts Calc Phos Bone Health 2CALCAREA PHOSPHORICAMartin & Pleasance Pty Ltdc277f1d8-2ee0-4111-adb6-38998f77dede2025-07-18WarningsExact identifier
unii: L11K75P92J
HydrochlorothiazideHYDROCHLOROTHIAZIDEBryant Ranch Prepack73bc116a-2964-4acc-9ef0-0a3f662689132025-07-14Warnings, Adverse reactionsExact identifier
rxcui: 310798
unii: 0J48LPH2TH
Olmesartan Medoxomil and HydrochlorothiazideOLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEBryant Ranch Prepack0360db3a-17cf-4d24-97ba-e0a6fcc943512025-07-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Triamterene and HydrochlorothiazideTRIAMTERENE AND HYDROCHLOROTHIAZIDEA-S Medication Solutionsf4f026f9-5f21-435e-8878-01dc9bbe2d662025-07-10Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Schuessler Tissue Salts Calc Phos Bone Health 2CALCAREA PHOSPHORICAMartin & Pleasance Pty Ltd81d59754-1b36-4f71-aec1-5335b003a96f2025-07-01WarningsExact identifier
unii: L11K75P92J
losartan potassium and hydrochlorothiazideLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEUnichem Pharmaceuticals (USA), Inc.f61b4ffe-cca6-482d-88fa-adf22cb3fff22025-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH

Reported adverse events (FAERS/openFDA)#

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