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 18 of 44 · 864 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Benazepril Hydrochloride and HydrochlorothiazideBENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDEANI Pharmaceuticals, Inc.e6527adf-8c74-4d81-9199-d56a7fca895e2025-11-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
HYZAARLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEOrganon LLC4116ccde-2e23-45f4-b12f-6337df8777442025-11-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Lisinopril and HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDELupin Pharmaceuticals, Inc.515f735c-5dba-43d9-8a58-97a319cafd562025-11-24Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA077912
ndc (product): 68180-520
ndc (product): 68180-519
ndc (product): 68180-518
rxcui: 197886
rxcui: 197885
rxcui: 197887
spl id: 4035482a-7e09-464f-ae01-a8a75fc3c4c1
spl set id: 515f735c-5dba-43d9-8a58-97a319cafd56
unii: E7199S1YWR
unii: 0J48LPH2TH
Losartan Potassium and HydrochlorothiazideLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDESolco Healthcare US, LLC6d677f9e-c0e4-4d6e-bea2-a58e986e46352025-11-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
CONSTIPATIONMAGNESIA CARBONICA, MAGNESIA MURIATICA, AESCULUS HIPPOCASTANUM, ALUMEN, ALUMINA, BRYONIA ALBA, NUX VOMICA, SILICEANatural Creations, Inc.d2e24f5a-747b-4d62-bbdf-16c0e43becdb2025-11-21WarningsExact identifier
unii: LMI26O6933
HydrochlorothiazideHYDROCHLOROTHIAZIDEA-S Medication Solutions0937d511-4d5e-4aba-bfae-92094c67bcf42025-11-20Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
HydrochlorothiazideHYDROCHLOROTHIAZIDEPD-Rx Pharmaceuticals, Inc.c182b6a9-1a31-45ee-9cea-a557c99f5db72025-11-20Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
HydrochlorothiazideHYDROCHLOROTHIAZIDEA-S Medication Solutionsef8a7dee-3704-4c62-8981-f8adfb47f5d02025-11-20Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDEA-S Medication Solutions67c48f86-f412-4957-8e15-aec89e07d2952025-11-18Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDEA-S Medication Solutions42542233-b992-4953-87ec-5095b196d61b2025-11-18Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Calamine Plus Pramoxine HClCALAMINE PLUS SPRAYKroger Co.6b3e7aac-395f-48cf-9c5e-f7e163724aef2025-11-17WarningsExact identifier
unii: 1K09F3G675
Calamine Plus Pramoxine HClCALAMINE PLUS SPRAYHY-VEE, INC415ecfe9-3145-f23e-e063-6394a90adfd82025-11-17WarningsExact identifier
unii: 1K09F3G675
Berberis ViscumBERBERIS VISCUMUriel Pharmacy Inc.30abbbd6-1657-4959-9f07-85ddf45f11192025-11-14WarningsExact identifier
unii: LMI26O6933
QR PAINANALGESICMARYHELENE ENTERPRISES INC8f8f53e3-fe31-e7b5-e053-2995a90a710d2025-11-14WarningsExact identifier
unii: 3OWL53L36A
QR PAINANALGESICMARYHELENE ENTERPRISES INC9984a510-30be-4013-e053-2995a90a841e2025-11-14WarningsExact identifier
unii: 3OWL53L36A
ALUMIZENGARLIC, AVENA SATIVA FLOWERING TOP, BERBERIS VULGARIS ROOT BARK, ARCTIUM LAPPA ROOT, PHYTOLACCA AMERICANA ROOT, SOLIDAGO VIRGAUREA FLOWERING TOP, ALUMINUM OXIDE, SILVER NITRATE, BARIUM CARBONATE, BERYLLIUM, CADMIUM, COPPER, HYDROFLUORIC ACID, INDIUM, IODINE, LITHIUM CARBONATE, MERCURIUS SOLUBILIS, NICKEL CARBONATE HYDROXIDE TETRAHYDRATE, NITROUS OXIDE, LEAD, SELENIUM, STRONTIUM CARBONATE, TITANIUM, ARSENIC TRIOXIDE, SODIUM CHLORIDE, STRYCHNOS NUX-VOMICA SEED.Natural Creations, Inc.4760ab09-1141-4944-b840-804ae6d86d2d2025-11-13WarningsExact identifier
unii: LMI26O6933
LisinoprilLISINOPRILAmerican Health Packaginga2f31909-3cda-4580-adfa-e9992d8c08852025-11-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: E7199S1YWR
Lisinopril and HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDEA-S Medication Solutionscd62e287-b648-459a-9414-621686c6b6072025-11-10Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA077912
rxcui: 197886
rxcui: 197885
rxcui: 197887
unii: E7199S1YWR
unii: 0J48LPH2TH
Au Kah Chuen FugicalCALAMINE AND DIPHENHYDRAMINE HYDROCHLORIDZhejiang Dingtai Pharmaceutical Co., Ltd5b4add17-6c3d-4093-826a-2edb41c1d1db2025-11-10WarningsExact identifier
unii: 1K09F3G675
FARGELIN HEMORRHOIDALCALAMINE, PETROLATUM AND PHENYLEPHRINE HYDROCHLORIDEMADISON ONE ACME INC6844ad63-512d-496a-9458-011894185b0d2025-11-10WarningsExact identifier
unii: 1K09F3G675

Reported adverse events (FAERS/openFDA)#

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