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 40 of 44 · 864 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lisinopril and HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDEProficient Rx LP2bcd9e20-2839-4cc0-9d1d-74b2cf17a96e2022-05-01Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA077912
rxcui: 197886
unii: E7199S1YWR
unii: 0J48LPH2TH
LisinoprilLISINOPRILProficient Rx LPb2d493bf-f4d8-4941-8c54-2728d769f6ed2022-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: E7199S1YWR
LISINOPRILLISINOPRILProficient Rx LP3e4e69f6-b8a6-462d-a7ec-4cd6636512d02022-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: E7199S1YWR
LISINOPRIL AND HYDROCHLOROTHIAZIDELISINOPRIL AND HYDROCHLOROTHIAZIDEProficient Rx LPd9895efd-fb9d-4ce9-818a-31d724b162952022-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA077912
rxcui: 197885
rxcui: 197887
unii: E7199S1YWR
unii: 0J48LPH2TH
HydrochlorothiazideHYDROCHLOROTHIAZIDEProficient Rx LPfd9b3e5a-f564-4730-8b9f-2cdc2953cbc92022-04-01Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
LisinoprilLISINOPRILProficient Rx LP8a14eaa6-cb8b-4088-ba15-840b587ab1f72022-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: E7199S1YWR
LISINOPRILLISINOPRILProficient Rx LP06862c94-103d-4b12-8a74-abf52cb423892022-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: E7199S1YWR
LisinoprilLISINOPRILAphena Pharma Solutions - Tennessee, LLCb8a2a160-0287-41dc-a717-c7fcde7e091f2022-03-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: E7199S1YWR
LisinoprilLISINOPRILAphena Pharma Solutions - Tennessee, LLC1b9ddfd8-0acc-4fb5-a948-bb2c0cc23a912022-03-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: E7199S1YWR
HydrochlorothiazideHYDROCHLOROTHIAZIDEProficient Rx LPb54ec2b1-3325-46a1-b654-8a75dc41ab0a2022-03-01Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
LISINOPRILLISINOPRILAphena Pharma Solutions - Tennessee, LLC2dbec080-a266-4317-8d4b-b4046206416e2022-02-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: E7199S1YWR
Quinapril and Hydrochlorothiazide 10/12.5QUINAPRIL AND HYDROCHLOROTHIAZIDE 10/12.5Cipla USA Inc.1de5420c-23d6-40c5-ba24-39143c0f90fb2022-01-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
HydrochlorothiazideHYDROCHLOROTHIAZIDEBryant Ranch Prepack4c3403a6-da6a-4f37-bc7e-9fe0aa2843052021-12-07Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
LisinoprilLISINOPRILProficient Rx LP55a57d80-6bed-44a3-b3ea-6bb44c34cbfc2021-12-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: E7199S1YWR
CONSTIPATION CPALUMINUM OXIDE, BRYONIA ALBA ROOT, MATRICARIA RECUTITA, GRAPHITE, LYCOPODIUM CLAVATUM SPORE, STRYCHNOS NUX-VOMICA SEED, SILICON DIOXIDE, SULFUR, SODIUM CHLORIDE, MAGNESIUM CHLORIDE, LEAD, SEPIA OFFICINALIS JUICE.Natural Creations, Inc.961b3ddf-41fe-46ed-b5e4-0fd8d9652edf2021-11-15WarningsExact identifier
unii: LMI26O6933
Lisinopril and HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETSCipla USA Inc.40e6b627-63dc-4d52-aaa8-750663ad86c22021-11-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197886
rxcui: 197885
rxcui: 197887
unii: E7199S1YWR
unii: 0J48LPH2TH
Triamterene and HydrochlorothiazideTRIAMTERENE AND HYDROCHLOROTHIAZIDEAphena Pharma Solutions - Tennessee, LLCb129e54a-a6d8-42c0-baac-e8db2487369b2021-11-05Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
LisinoprilLISINOPRILCamber Pharmaceuticals, Inc.8f20acd7-2635-4a9b-b732-2a84ea93dea72021-11-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: E7199S1YWR
triamterene and hydrochlorothiazideTRIAMTERENE AND HYDROCHLOROTHIAZIDEAphena Pharma Solutions - Tennessee, LLC236dead0-16d5-4383-860f-30743730a0882021-10-28Boxed warning, Adverse reactionsExact identifier
unii: 0J48LPH2TH
ALUMINAALUMINARxhomeo Private Limited d.b.a. Rxhomeo, Incf23b1f6d-d962-482b-9479-dcddf793aad32021-09-26WarningsExact identifier
unii: LMI26O6933

Reported adverse events (FAERS/openFDA)#

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