FDA.reportPublic FDA data

NDC 68788-9809-01 - LISINOPRIL AND 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
68788-9809
Requested NDC
68788-9809-01
Package NDCs from labels
68788-9809-3, 68788-9809-6, 68788-9809-9, 68788-9809-1, 68788-9809-01
Manufacturer
Preferred Pharmaceuticals, Inc.
Effective date
2026-05-22
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS USPPreferred Pharmaceuticals, Inc.2026-05-22HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68788-9809-1LISINOPRIL AND HYDROCHLOROTHIAZIDE100 in 1 BOTTLETABLET10013
68788-9809-3LISINOPRIL AND HYDROCHLOROTHIAZIDE30 in 1 BOTTLETABLET3013
68788-9809-6LISINOPRIL AND HYDROCHLOROTHIAZIDE60 in 1 BOTTLETABLET6013
68788-9809-9LISINOPRIL AND HYDROCHLOROTHIAZIDE90 in 1 BOTTLETABLET9013

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-9809LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET [PREFERRED PHARMACEUTICALS, INC.]11Current NDC, Legacy NDC, 4 package rows20240621_5aa18b0b-4688-493a-a5ae-cb056ea6c0e3.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROCHLOROTHIAZIDEACTIVE INGREDIENT0J48LPH2THLISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET [PREFERRED PHARMACEUTICALS, INC.]2
LISINOPRILACTIVE INGREDIENTE7199S1YWRLISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET [PREFERRED PHARMACEUTICALS, INC.]2
HYDROCHLOROTHIAZIDEACTIVE MOIETY0J48LPH2THLISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET [PREFERRED PHARMACEUTICALS, INC.]2
LISINOPRIL ANHYDROUSACTIVE MOIETY7Q3P4BS2FDLISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET [PREFERRED PHARMACEUTICALS, INC.]2
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET [PREFERRED PHARMACEUTICALS, INC.]2
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JLISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET [PREFERRED PHARMACEUTICALS, INC.]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKLISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET [PREFERRED PHARMACEUTICALS, INC.]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET [PREFERRED PHARMACEUTICALS, INC.]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTLISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET [PREFERRED PHARMACEUTICALS, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET [PREFERRED PHARMACEUTICALS, INC.]2
MANNITOLINACTIVE INGREDIENT3OWL53L36ALISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET [PREFERRED PHARMACEUTICALS, INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET [PREFERRED PHARMACEUTICALS, INC.]2

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 24 of 44 · 864 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
VALSARTAN AND HYDROCHLOROTHIAZIDEVALSARTAN AND HYDROCHLOROTHIAZIDEBryant Ranch Prepack46addda8-f798-4207-b8fb-ea75c5903a362025-05-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDEOLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEMacleods Pharmaceuticals Limited03ff0f7e-6aa1-4c38-8c9a-5f1c6a56c7472025-05-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
MannitolMANNITOLHenry Schein, Inc.e2444db1-9dfe-451f-a33c-9b00786464d22025-05-20Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
Candesartan Cilexetil and HydrochlorothiazideCANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDEMacleods Pharmaceuticals Limited76630807-9717-44be-946d-756038cf677e2025-05-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
HydrochlorothiazideHYDROCHLOROTHIAZIDEA-S Medication Solutions02a481cb-ad80-41bb-82d3-c237b00ed8d72025-05-15Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
ApnetemPHOSPHORICUM ACIDUM, ALUMEN, PHOSPHORUS, SENEGA OFFICINALIS, ADENOSINUM CYCLOPHOSPHORICUM, ANTIMONIUM TARTARICUM, GRINDELIA, SABADILLA, ALUMINA, CUPRUM METALLICUM, SANGUINARINUM NITRICUM, SILICEA, LACHESIS MUTUS, RHEUM (PALMATUM), ZINCUM METALLICUM, LYCOPODIUM CLAVATUM, MANGANUM PHOSPHORICUM, ANTIPYRINUM, COENZYME ANucleic Products, LLCec5bc7e7-4be6-45a6-8cd9-62fdfa7fb4692025-05-14WarningsExact identifier
unii: LMI26O6933
HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDEREMEDYREPACK INC.1570f1ad-8372-477f-89c3-8c9ce01e27d12025-05-07Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
PowderTITANIUM DIOXIDEOxygen Development LLC08b7eeeb-09ae-ffe6-e063-6294a90aba902025-05-07WarningsExact identifier
unii: 1K09F3G675
LISINOPRILLISINOPRILAsclemed USA, Inc.db5bfa2f-07b8-4f79-8a40-691da006e2ed2025-05-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: E7199S1YWR
HydrochlorothiazideHYDROCHLOROTHIAZIDEPreferred Pharmaceuticals Inc.82ad0fdf-5d47-4c2d-883b-f28b2d3fb6b02025-04-29Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
HydrochlorothiazideHYDROCHLOROTHIAZIDENuCare Pharmaceuticals,Inc.fea5a353-9b13-9b87-e053-6394a90a627d2025-04-25Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
LISINOPRILLISINOPRILPD-Rx Pharmaceuticals, Inc.bf59ff89-a9fa-4fe3-b167-a5d0cba9e4382025-04-11Boxed warning, Warnings, Adverse reactionsExact identifier
unii: E7199S1YWR
LISINOPRILLISINOPRILPD-Rx Pharmaceuticals, Inc.03a497fe-fb09-4b2c-8ee0-2019600192b82025-04-11Boxed warning, Warnings, Adverse reactionsExact identifier
unii: E7199S1YWR
LISINOPRILLISINOPRILPD-Rx Pharmaceuticals, Inc.dd015c18-1ea6-44e3-9186-8d2f8444d8742025-04-11Boxed warning, Warnings, Adverse reactionsExact identifier
unii: E7199S1YWR
LISINOPRILLISINOPRILPD-Rx Pharmaceuticals, Inc.e4c11545-00da-4675-856a-7e600a2f4bd92025-04-11Boxed warning, Warnings, Adverse reactionsExact identifier
unii: E7199S1YWR
OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDEOLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDENorthStar RxLLC364af4fe-cde8-466f-b56f-d93d532b56f52025-04-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDEAMLODIPINE BESYLATE VALSARTAN HYDROCHLOROTHIAZIDEStrides Pharma Science Limited9b76e441-e6a5-4036-8276-b7788ade5c442025-04-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
LisinoprilLISINOPRILBryant Ranch Prepackcced442b-8047-4489-95d6-0700a66fba342025-04-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: E7199S1YWR
ZestoreticLISINOPRIL AND HYDROCHLOROTHIAZIDEAlmatica Pharma Inc.0d3a966f-f937-05a8-a90f-5aa52ebbd6132025-03-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197886
rxcui: 197885
rxcui: 197887
unii: E7199S1YWR
unii: 0J48LPH2TH
RID Poison Ivy Rash ReliefCALAMINE AND ZINC OXIDEOystershell Consumer Health Inc.36c3af9a-2646-4427-e063-6394a90a2c5e2025-03-13WarningsExact identifier
unii: 1K09F3G675

Reported adverse events (FAERS/openFDA)#

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