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 15 of 28 · 558 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TELMISARTAN AND HYDROCHLOROTHIAZIDETELMISARTAN AND HYDROCHLOROTHIAZIDESolco Healthcare LLC47c8eee0-f0b7-4bd8-97e9-0029aa1b37db2025-06-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
olmesartan medoxomil and amlodipine besylate and hydrochlorothiazideOLMESARTAN MEDOXOMIL AND AMLODIPINE BESYLATE AND HYDROCHLOROTHIAZIDESlate Run Pharmaceuticals, LLCa469adff-25a6-4983-b471-60924d920a862025-06-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
HydrochlorothiazideHYDROCHLOROTHIAZIDENuCare Pharmaceuticals,Inc.8d5a9196-5f1d-2d83-e053-2a95a90a60362025-06-27Warnings, Adverse reactionsExact identifier
application number: ANDA083177
ndc (package): 68071-4963-1
ndc (package): 68071-4963-9
ndc (product): 68071-4963
ndc11 (package): 68071496301
rxcui: 310798
spl id: 38945ef2-5c46-e10f-e063-6394a90acca9
spl set id: 8d5a9196-5f1d-2d83-e053-2a95a90a6036
unii: 0J48LPH2TH
Spironolactone and HydrochlorothiazideSPIRONOLACTONE AND HYDROCHLOROTHIAZIDEBryant Ranch Prepackd5387b26-90a3-44f0-850b-8aa1219fd26b2025-06-26Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
losartan potassium and hydrochlorothiazideLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEBryant Ranch Prepackeb423f4b-8104-4406-bfc2-8943e517329f2025-06-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Olmesartan Medoxomil and HydrochlorothiazideOLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEAlembic Pharmaceuticals Inc.ca1a0aac-d81d-4c0a-91ea-cb719af772bf2025-06-25Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDEOLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEA-S Medication Solutions5c4c5907-36f0-461e-b0c9-d51edff32a972025-06-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
hydrochlorothiazideHYDROCHLOROTHIAZIDEAmerican Health Packaging13ed002f-c5bb-401c-891a-70b70cbd8fb62025-06-18Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Benazepril Hydrochloride and HydrochlorothiazideBENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDESandoz Incc9bdfbb4-87b6-4de4-bc1d-5025d3ef591f2025-06-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
HydrochlorothiazideHYDROCHLOROTHIAZIDEUnichem Pharmaceuticals (USA), Inc.33f3b980-b339-4dbf-99bd-05588c2a298c2025-06-13Warnings, Adverse reactionsExact identifier
rxcui: 310798
unii: 0J48LPH2TH
Losartan potassium and HydrochlorothiazideLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEBryant Ranch Prepack352061ee-942d-6cba-e063-6294a90a9eea2025-06-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDEOLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEA-S Medication Solutionsf7415f1d-98c7-454f-bb1a-f59e95652c882025-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Bisoprolol Fumarate and HydrochlorothiazideBISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDEBryant Ranch Prepack794d4a5a-de31-4878-95d5-23552dd2171e2025-06-04Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Olmesartan Medoxomil and HydrochlorothiazideOLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEAurobindo Pharma Limited744c1785-42b2-46a5-b0f4-2887a9ec20512025-06-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDEAMLODIPINE BESYLATE VALSARTAN HYDROCHLOROTHIAZIDEGolden State Medical Supply, Inc.e9ecbadb-c548-6fe5-e053-2a95a90a75772025-06-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
VALSARTAN AND HYDROCHLOROTHIAZIDEVALSARTAN AND HYDROCHLOROTHIAZIDEBryant Ranch Prepackf1df0d1e-d418-4f6e-a04a-77b5d4000e2b2025-06-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.c59c4230-7cea-4259-9f2f-6a568716fedf2025-06-02Warnings, Adverse reactionsExact identifier
rxcui: 310798
unii: 0J48LPH2TH
Bisoprolol Fumarate and HydrochlorothiazideBISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDEBryant Ranch Prepack8d3e9c30-8dcf-491a-a515-6890b391398e2025-05-29Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
VALSARTAN AND HYDROCHLOROTHIAZIDEVALSARTAN AND HYDROCHLOROTHIAZIDEBryant Ranch Prepackd55b2f01-5cd1-40bb-8d36-34b5b9081ddc2025-05-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
VALSARTAN AND HYDROCHLOROTHIAZIDEVALSARTAN AND HYDROCHLOROTHIAZIDEBryant Ranch Prepack46addda8-f798-4207-b8fb-ea75c5903a362025-05-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH

Reported adverse events (FAERS/openFDA)#

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