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 10 of 28 · 558 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lisinopril and HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDENorthwind Health Company, LLCf2b94985-c79d-40e3-e053-2a95a90a0d782026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Lisinopril and HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDENorthwind Health Company, LLCc97e38f2-7163-4d4e-a694-4d0612423e532026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
HydrochlorothiazideHYDROCHLOROTHIAZIDENorthwind Health Company, LLCf2f3b60a-bffe-2675-e053-2995a90ae96e2026-01-01Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
HydrochlorothiazideHYDROCHLOROTHIAZIDENorthwind Health Company, LLCf7091c54-0984-7f6e-e053-6394a90afb4d2026-01-01Warnings, Adverse reactionsExact identifier
application number: ANDA083177
rxcui: 310798
unii: 0J48LPH2TH
HydrochlorothiazideHYDROCHLOROTHIAZIDENorthwind Health Company, LLCf68d211d-d802-6c78-e053-2995a90a90d72026-01-01Warnings, Adverse reactionsExact identifier
rxcui: 310798
unii: 0J48LPH2TH
Lisinopril and HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDENorthwind Health Company, LLC3984e6b9-2d88-47f0-af09-cce428bba14f2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Triamterene and HydrochlorothiazideTRIAMTERENE AND HYDROCHLOROTHIAZIDENorthwind Health Company, LLCdb895e64-3f97-9201-e053-2a95a90ac7ef2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDEOLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDESolco Healthcare US, LLCbdca31d3-60b1-4659-aef7-56530b4f90392025-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Losartan Potassium and HydrochlorothiazideLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEA-S Medication Solutionsbc8b9ae2-8263-4624-8629-4f856392f9da2025-12-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Losartan Potassium and HydrochlorothiazideLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDETeva Pharmaceuticals USA, Inc.deafd195-7a1b-4ad8-a371-2cd9f433dea52025-12-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Medicated Cornstarch Baby PowderACTIVE CORN STARCHDavion, Inc.e39032d1-c8cd-4a41-af10-126970b8ad382025-12-29WarningsExact identifier
unii: O8232NY3SJ
HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDENorthwind Health Company, LLC076017ce-8aad-1336-e063-6394a90a76b52025-12-26Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Triamterene and HydrochlorothiazideTRIAMTERENE AND HYDROCHLOROTHIAZIDENorthwind Health Company, LLC08f3885e-dfde-79e4-e063-6394a90a4c092025-12-26Boxed warning, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Losartan Potassium and HydrochlorothiazideLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEAlembic Pharmaceuticals Inc.acecced9-2a61-435d-b7d4-b151cb7b7e5d2025-12-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
ATACAND HCTCANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDEANI Pharmaceuticals, Inc.d91152c4-66ba-466f-b4f9-0da628d42b1d2025-12-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Candesartan Cilexetil and HydrochlorothiazideCANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDEANI Pharmaceuticals, Inc.bd8d318d-167a-4b26-935d-265dde3193de2025-12-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Lisinopril and HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDEQPharma, Inc.c80b2164-3795-6668-e053-2a95a90a4d452025-12-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Irbesartan and HydrochlorothiazideIRBESARTAN AND HYDROCHLOROTHIAZIDEAurobindo Pharma Limited466dd0d2-9815-4c3e-b66b-d0732b3ba8e92025-12-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Irbesartan and HydrochlorothiazideIRBESARTAN AND HYDROCHLOROTHIAZIDEUnichem Pharmaceuticals (USA), Inc.181324c5-256f-4570-a0bb-8bc908deb2e22025-12-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDEA-S Medication Solutionsf9faec8a-2b71-47bb-a296-48ecbce9af502025-12-16Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH

Reported adverse events (FAERS/openFDA)#

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