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 17 of 28 · 558 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDELOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEDirect Rxd8284747-07b6-9775-e053-2a95a90ad52d2025-01-21Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDELOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEDirect Rxd88ad738-a915-7679-e053-2a95a90a58c72025-01-21Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDEPreferred Pharmaceuticals Inc.93f6a018-8b3d-4f40-be25-902daec19aea2025-01-21Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDEDIRECT RXcbe5e01e-67ca-f8a2-e053-2995a90a0d152025-01-20Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDELOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEDirectRxcf4278a3-fbb7-a8ab-e053-2a95a90abc0f2025-01-20Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDELOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEDirectRxd1ed9593-a587-55bb-e053-2995a90a8a9a2025-01-20Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDELOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEDirectRxd1ee193e-bf78-3134-e053-2a95a90a65d22025-01-20Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDELOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEDirectRxd2021060-94d7-3e1d-e053-2995a90a10ee2025-01-20Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDELOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEDirect_Rx8de04bf2-83dd-c494-e053-2a95a90abade2025-01-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
amlodipine,valsartan and hydrochlorothiazideAMLODIPINE,VALSARTAN AND HYDROCHLOROTHIAZIDEMacleods Pharmaceuticals Limited1ea4f227-b97a-49f1-bbc3-1dede2c1866d2025-01-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Triamterene and HydrochlorothiazideTRIAMTERENE AND HYDROCHLOROTHIAZIDEAmerican Health Packagingba764ce4-36fe-4aa4-96a4-d0479b875b4f2025-01-08Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Lisinopril and HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDEAdvanced Rx Pharmacy of Tennessee, LLCecac0280-6faa-e7f3-e053-2995a90a2bd92024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Micardis HCTTELMISARTAN AND HYDROCHLOROTHIAZIDEBoehringer Ingelheim Pharmaceuticals, Inc.b078dae2-664d-4144-847a-3b9d9b5574022024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDEOLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEA-S Medication Solutions4a2c2b8f-1479-4555-9ba8-ca44070032962024-12-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Losartan Potassium and HydrochlorothiazideLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEQuality Care Products, LLCa6241e63-1952-4dfa-ba94-c406059501dd2024-12-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
hydrochlorothiazideHYDROCHLOROTHIAZIDEQuality Care Products LLCa2de8e26-ef5a-41c7-888b-990629b111452024-12-19Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
HydrochlorothiazideHYDROCHLOROTHIAZIDELake Erie Medical DBA Quality Care Products LLC9e6a0c83-1494-44ca-90e0-3f43fa8ec7462024-12-16Warnings, Adverse reactionsExact identifier
rxcui: 310798
unii: 0J48LPH2TH
Lisinopril and HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETSAphena Pharma Solutions - Tennessee, LLC2902430c-0bfe-483e-e063-6294a90a92d72024-12-11Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
HydrochlorothiazideHYDROCHLOROTHIAZIDEBryant Ranch Prepack5f2e72cc-073d-4bb5-95fe-53d4060127ec2024-12-05Warnings, Adverse reactionsExact identifier
rxcui: 310798
unii: 0J48LPH2TH
Losartan Potassium and HydrochlorothiazideLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEBryant Ranch Prepack927315ca-211b-4976-b228-cf544f7e52592024-11-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH

Reported adverse events (FAERS/openFDA)#

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