FDA.reportPublic FDA data

NDC 67046-433-03 - 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
67046-433
Requested NDC
67046-433-03
Package NDCs from labels
67046-433-07, 67046-433-14, 67046-433-15, 67046-433-20, 67046-433-60, 67046-433-28, 67046-433-30, 67046-433-21, 67046-433-03
Manufacturer
Contract Pharmacy Services-PA | Coupler Enterprises Inc.
Effective date
2017-09-27
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
433 Lisinopril/HCTZ 20/12.5 mg LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS USPContract Pharmacy Services-PA | Coupler Enterprises Inc.2017-09-27HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDCRelated label
67046-433-07433 Lisinopril/HCTZ 20/12.5 mg LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS USP
67046-433-14433 Lisinopril/HCTZ 20/12.5 mg LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS USP
67046-433-15433 Lisinopril/HCTZ 20/12.5 mg LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS USP
67046-433-20433 Lisinopril/HCTZ 20/12.5 mg LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS USP
67046-433-21433 Lisinopril/HCTZ 20/12.5 mg LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS USP
67046-433-28433 Lisinopril/HCTZ 20/12.5 mg LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS USP
67046-433-30433 Lisinopril/HCTZ 20/12.5 mg LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS USP
67046-433-60433 Lisinopril/HCTZ 20/12.5 mg LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67046-433-07Lisinopril and Hydrochlorothiazide7 in 1 BLISTER PACKTABLET71
67046-433-14Lisinopril and Hydrochlorothiazide14 in 1 BLISTER PACKTABLET141
67046-433-15Lisinopril and Hydrochlorothiazide15 in 1 BLISTER PACKTABLET151
67046-433-20Lisinopril and Hydrochlorothiazide20 in 1 BLISTER PACKTABLET201
67046-433-21Lisinopril and Hydrochlorothiazide21 in 1 BLISTER PACKTABLET211
67046-433-28Lisinopril and Hydrochlorothiazide28 in 1 BLISTER PACKTABLET281
67046-433-30Lisinopril and Hydrochlorothiazide30 in 1 BLISTER PACKTABLET301
67046-433-60Lisinopril and Hydrochlorothiazide60 in 1 BLISTER PACKTABLET601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67046-433LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET [CONTRACT PHARMACY SERVICES-PA]1Legacy NDC, 8 package rows20170928_5a31bdda-ec18-139c-e053-2991aa0a3c0c.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 5 of 37 · 724 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lisinopril and HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETSPreferred Pharmaceuticals Inc.9207c3bc-e12e-4017-8b85-0f928e744f642026-05-22Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197885
unii: E7199S1YWR
unii: 0J48LPH2TH
LISINOPRILLISINOPRILPreferred Pharmaceuticals Inc.7e297133-669e-4780-a966-c777624e54272026-05-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: E7199S1YWR
LISINOPRILLISINOPRILPreferred Pharmaceuticals Inc.affd3e43-077e-42e5-a865-c961624bfe932026-05-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: E7199S1YWR
Lisinopril and HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETSPreferred Pharmaceuticals Inc.fc4d7d0e-78a6-4d7e-ba53-aeeb008aa2dc2026-05-22Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197886
unii: E7199S1YWR
unii: 0J48LPH2TH
OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDEOLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEScieGen Pharmaceuticals Inc52332190-2a12-d205-e063-6394a90ab7c52026-05-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
LISINOPRILLISINOPRILPreferred Pharmaceuticals Inc.02c23f9c-f3cf-4366-ae1e-56296f1fedf92026-05-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: E7199S1YWR
Olmesartan Medoxomil and HydrochlorothiazideOLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEBryant Ranch Prepack77e71a2e-8370-4f7a-a5e4-93d86bd37dad2026-05-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Lisinopril and HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDEBryant Ranch Prepack544b75eb-55f1-4164-9b83-39f6bc5fb4792026-05-22Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA077912
rxcui: 197885
unii: E7199S1YWR
unii: 0J48LPH2TH
LISINOPRILLISINOPRILPreferred Pharmaceuticals, Inc.74415f95-74c9-4329-a6af-a0f165bf78872026-05-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: E7199S1YWR
Spironolactone and HydrochlorothiazideSPIRONOLACTONE AND HYDROCHLOROTHIAZIDEBryant Ranch Prepackc5258ea3-3aac-48fd-be5a-f8e4a47ca94a2026-05-21Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
LisinoprilLISINOPRILCardinal Health 107, LLC1d0caa63-9ea2-4a97-a23b-900a7c514bc62026-05-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: E7199S1YWR
HydrochlorothiazideHYDROCHLOROTHIAZIDEBryant Ranch Prepacka013211e-b8f8-426d-8e55-e86193f0634e2026-05-19Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
HydrochlorothiazideHYDROCHLOROTHIAZIDEBryant Ranch Prepackf22a10a2-8f84-4060-9143-427237c512802026-05-19Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Triamterene and HydrochlorothiazideTRIAMTERENE AND HYDROCHLOROTHIAZIDEBryant Ranch Prepackf3bc491a-961d-4a38-8a55-c4a03be05b742026-05-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Irbesartan and HydrochlorothiazideIRBESARTAN AND HYDROCHLOROTHIAZIDEBryant Ranch Prepacke6c35575-9c3f-42f8-b8b8-577a29f9d3812026-05-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
HydrochlorothiazideHYDROCHLOROTHIAZIDEBryant Ranch Prepack2b21f3fc-4164-401a-803e-b982dea97e192026-05-14Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
HydrochlorothiazideHYDROCHLOROTHIAZIDEPD-Rx Pharmaceuticals, Inc.27a7e751-8aca-440e-95e4-cfecae1a24652026-05-13Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Bisoprolol Fumarate and HydrochlorothiazideBISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDEMylan Pharmaceuticals Inc.d4243a76-516c-417e-80ba-444a21ecc6882026-05-12Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDEOLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEBryant Ranch Prepack68d44330-4213-46a7-97b9-f858c16454d12026-05-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDEOLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEBryant Ranch Prepack78eb9041-a738-4056-8705-8c1dd13a4da42026-05-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH

Reported adverse events (FAERS/openFDA)#

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