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 34 of 44 · 864 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Triamterene and HydrochlorothiazideTRIAMTERENE AND HYDROCHLOROTHIAZIDEBryant Ranch Prepack6517777a-e49e-4da6-b34b-66ec58cceff72024-01-16Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
LisinoprilLISINOPRILA-S Medication Solutionscce5bcc0-2e38-41d8-a41e-4f4ea83e62482024-01-16Boxed warning, Warnings, Adverse reactionsExact identifier
unii: E7199S1YWR
Lisinopril and HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETSNuCare Pharmaceuticals,Inc.e0511312-0b07-be89-e053-2995a90ab1e52024-01-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197887
unii: E7199S1YWR
unii: 0J48LPH2TH
LisinoprilLISINOPRILBryant Ranch Prepack3783ab4c-2bed-414e-8927-62d47e3e34962024-01-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: E7199S1YWR
LisinoprilLISINOPRILBryant Ranch Prepack5af2444f-438c-4ea6-96e8-3dba1af9e1a52024-01-11Boxed warning, Warnings, Adverse reactionsExact identifier
unii: E7199S1YWR
olmesartan medoxomil / amlodipine besylate / hydrochlorothiazideOLMESARTAN MEDOXOMIL / AMLODIPINE BESYLATE / HYDROCHLOROTHIAZIDEBryant Ranch Prepack44dc874b-4377-46eb-ae32-8d84c9c4d4ae2024-01-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
LisinoprilLISINOPRILA-S Medication Solutions24aab432-9c51-4aee-b9b6-f38816d613bb2024-01-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: E7199S1YWR
LISINOPRILLISINOPRILAphena Pharma Solutions - Tennessee, LLCaeee8e9a-333a-416e-ab69-a0d40e1468832024-01-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: E7199S1YWR
Metoprolol Tartrate and HydrochlorothiazideMETOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDEAlembic Pharmaceuticals Inc.2b77f66f-6891-4977-be8f-7955473d2f922024-01-04Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Bisoprolol Fumarate and HydrochlorothiazideBISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDEA-S Medication Solutions78df389a-0916-46db-a536-72cae9ad6c082024-01-02Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Metoprolol Tartrate and HydrochlorothiazideMETOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDESun Pharmaceutical Industries, Inc.faaf13ce-5d8d-4c57-a49f-a7a73daa41a52024-01-02Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Lisinopril and HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDEA-S Medication Solutionsb20aca90-db82-4fce-95a5-fb2b27c4a6c72024-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA077912
rxcui: 197887
unii: E7199S1YWR
unii: 0J48LPH2TH
LisinoprilLISINOPRILProficient Rx LP726a6f23-737a-4866-b4ba-b3c18cd2e1ac2024-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: E7199S1YWR
HydrochlorothiazideHYDROCHLOROTHIAZIDEA-S Medication Solutionsbd5728a2-6322-42e3-bd1e-e4915750e3982023-12-28Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
HydrochlorothiazideHYDROCHLOROTHIAZIDEA-S Medication Solutions01ad3531-5ed9-434c-b7d5-02d72aa82e462023-12-25Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
LISINOPRILLISINOPRILAphena Pharma Solutions - Tennessee, LLCa32db461-4f77-46ef-b49b-250711dade172023-12-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: E7199S1YWR
Amlodipine, Valsartan and HydrochlorothiazideAMLODIPINE, VALSARTAN AND HYDROCHLOROTHIAZIDELupin Pharmaceuticals, Inc.5dbb43b1-3ea4-4fa5-a9aa-95d869ae65fe2023-12-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Quinapril and HydrochlorothiazideQUINAPRIL AND HYDROCHLOROTHIAZIDEChartwell RX, LLC2eae533f-d0af-47e8-a1f2-94bc8cc89b5a2023-12-11Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Triamterene and HydrochlorothiazideTRIAMTERENE AND HYDROCHLOROTHIAZIDEA-S Medication Solutions0eaf3aa9-7544-4717-944b-ec66af80770e2023-12-10Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Losartan Potassium and HydrochlorothiazideLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEA-S Medication Solutionsa4aa7f77-c98d-4b70-84bb-e16a06fc79522023-12-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH

Reported adverse events (FAERS/openFDA)#

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