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 13 of 28 · 558 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Triamterene and HydrochlorothiazideTRIAMTERENE AND HYDROCHLOROTHIAZIDEPreferred Pharmaceuticals Inc.1fff8245-2b65-4ab1-aaa2-6bbbc6ac5fe82025-10-01Boxed warning, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Triamterene and HydrochlorothiazideTRIAMTERENE AND HYDROCHLOROTHIAZIDEPreferred Pharmaceuticals Inc.5fc69fbf-c2d2-41ef-99bb-62a76ef74db22025-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Triamterene and HydrochlorothiazideTRIAMTERENE AND HYDROCHLOROTHIAZIDEBluePoint Laboratories4f44fb73-7f61-4623-ae89-61abd8e945ab2025-09-30Warnings, Adverse reactionsExact identifier
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
unii: 0J48LPH2TH
Triamterene and HydrochlorothiazideTRIAMTERENE AND HYDROCHLOROTHIAZIDEBryant Ranch Prepackec6dce85-5c0b-475c-af0b-cbbc034f698f2025-09-12Warnings, Adverse reactionsExact identifier
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
Olmesartan medoxomil and hydrochlorothiazideOLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDECamber Pharmaceuticals, Inc.d421f352-9500-4d3e-8bc3-0cdcc20505142025-08-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
HydrochlorothiazideHYDROCHLOROTHIAZIDEPD-Rx Pharmaceuticals, Inc.67bedecc-f758-4bc6-82c5-7d428cbbbd9b2025-08-22Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
HydrochlorothiazideHYDROCHLOROTHIAZIDEBryant Ranch Prepackd7d0867a-748e-4960-851f-ad764e07f7742025-08-20Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH

Reported adverse events (FAERS/openFDA)#

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