FDA.reportPublic FDA data

NDC 51672-4046-01 - Enalapril Maleate 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
51672-4046
Requested NDC
51672-4046-01
Package NDCs from labels
51672-4046-1, 51672-4046-3, 51672-4046-01
Manufacturer
Sun Pharmaceutical Industries, Inc. | Taro Pharmaceutical Industries, Ltd.
Effective date
2026-07-14
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Enalapril Maleate and Hydrochlorothiazide Tablets, USPSun Pharmaceutical Industries, Inc. | Taro Pharmaceutical Industries, Ltd.2026-07-14HUMAN PRESCRIPTION DRUG LABEL
Enalapril Maleate and Hydrochlorothiazide Tablets, USPNuCare Pharmaceuticals,Inc.2021-02-12HUMAN PRESCRIPTION DRUG LABEL
Enalapril Maleate and Hydrochlorothiazide - Rebel Distributors CorpRebel Distributors Corp2010-12-20HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51672-4046-1Enalapril Maleate and Hydrochlorothiazide100 in 1 BOTTLETABLET10012
51672-4046-3Enalapril Maleate and Hydrochlorothiazide1000 in 1 BOTTLETABLET100012

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-4046ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]12Current NDC, Legacy NDC, 2 package rows20240509_7cb92cf2-46f2-4379-937c-168d230e43a4.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-4046-1EA - Each51672-40460843b439-9694-412b-a9b3-6db98999e82712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Enalapril MaleateACTIVE INGREDIENT9O25354EPJENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]5
HydrochlorothiazideACTIVE INGREDIENT0J48LPH2THENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]5
Enalaprilat AnhydrousACTIVE MOIETYQ508Q118JMENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]5
HydrochlorothiazideACTIVE MOIETY0J48LPH2THENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]5
ferric oxide redINACTIVE INGREDIENT1K09F3G675ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]5
ferric oxide yellowINACTIVE INGREDIENTEX438O2MRTENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]5
ferrosoferric oxideINACTIVE INGREDIENTXM0M87F357ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]5
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]5
magnesium stearateINACTIVE INGREDIENT70097M6I30ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]5
sodium bicarbonateINACTIVE INGREDIENT8MDF5V39QOENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]5
starch, cornINACTIVE INGREDIENTO8232NY3SJENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]5
waterINACTIVE INGREDIENT059QF0KO0RENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]5
Enalapril MaleateACTIVE INGREDIENT9O25354EPJENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE TABLET [REBEL DISTRIBUTORS CORP]1
HydrochlorothiazideACTIVE INGREDIENT0J48LPH2THENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE TABLET [REBEL DISTRIBUTORS CORP]1
EnalaprilACTIVE MOIETY69PN84IO1AENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE TABLET [REBEL DISTRIBUTORS CORP]1
HydrochlorothiazideACTIVE MOIETY0J48LPH2THENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE TABLET [REBEL DISTRIBUTORS CORP]1
FERROUS OXIDEINACTIVE INGREDIENTG7036X8B5HENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE TABLET [REBEL DISTRIBUTORS CORP]1
lactoseINACTIVE INGREDIENTJ2B2A4N98GENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE TABLET [REBEL DISTRIBUTORS CORP]1
magnesium stearateINACTIVE INGREDIENT70097M6I30ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE TABLET [REBEL DISTRIBUTORS CORP]1
sodium bicarbonateINACTIVE INGREDIENT8MDF5V39QOENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE TABLET [REBEL DISTRIBUTORS CORP]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE TABLET [REBEL DISTRIBUTORS CORP]1

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 38 of 52 · 1,033 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lisinopril and HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDENuCare Pharmaceuticals,Inc.6c57bf12-9ad5-3a25-e053-2a91aa0aaf262024-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Losartan Potassium and HydrochlorothiazideLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDENuCare Pharmaceuticals,Inc.72c97b7f-d945-5106-e053-2a91aa0a9b3b2024-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Valsartan and HydrochlorothiazideVALSARTAN AND HYDROCHLOROTHIAZIDEAlembic Pharmaceuticals Inc.973973a3-9fec-4afc-910f-187f099dfe2d2024-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
CalamineFERRIC OXIDE REDNuCare Pharmaceuticals,Inc.66e98554-e158-a519-e053-2a91aa0a67832024-06-06Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
Omeprazole and Sodium BicarbonateOMEPRAZOLE AND SODIUM BICARBONATEANI Pharmaceuticals, Inc.63c3bd6c-a586-4ec0-8f45-ed936936dfeb2024-06-06Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
Eyes Alive Eye WashWATERRIVIERA PHARMA INC081079f4-1c06-4054-b771-00fedaa666f62024-06-05WarningsExact identifier
unii: 059QF0KO0R
1a150b79-955b-68ae-e063-6394a90a42915cf0d587-c1db-0293-e053-2991aa0a83c22024-06-04Boxed warning, Warnings, Adverse reactionsExact identifier
spl set id: 5cf0d587-c1db-0293-e053-2991aa0a83c2
Lisinopril and HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDEAphena Pharma Solutions - Tennessee, LLC1a04bf47-07fb-ed32-e063-6294a90a07cc2024-06-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Sterile WaterWATERBecton Dickinson and Company6e43c5a3-dad2-49ed-b500-964cb4563cc92024-05-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
hydrochlorothiazideHYDROCHLOROTHIAZIDEBryant Ranch Prepack6a11a458-dc69-40ba-a58a-649733e0e8ab2024-05-29Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
bisoprolol fumarate and hydrochlorothiazideBISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDEBryant Ranch Prepack447c11b6-72fe-418e-a2db-5d90b53477962024-05-23Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Lisinopril and HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDEBryant Ranch Prepack2b66693d-0514-4f41-b405-bd3dd7618e812024-05-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Lisinopril and HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETSBryant Ranch Prepack02eb8f54-789e-4148-912b-601d23a7df4a2024-05-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Triamterene and HydrochlorothiazideTRIAMTERENE AND HYDROCHLOROTHIAZIDEBryant Ranch Prepack4c74bc01-1065-79f0-f9c4-044ead38a55d2024-05-22Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
AllergiesAPIS MELLIFICA, ECHINACEA, HYDRASTIS CANADENSIS, TARAXACUM OFFICINALE, ACONITUM NAPELLUS, AETHUSA CYNAPIUM, AGARICUS MUSCARIUS, ALETRIS FARINOSA, ALFALFA, ALLIUM CEPA, ALLIUM SATIVUM, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM ALBUM, ARTEMISIA VULGARIS, ARUNDO MAURITANICA, AVENA SATIVA, BELLADONNA, BELLIS PERRENIS, BOVISTA, BROMIUM, BRYONIA, CAFFEINUM, CALCAREA CARBONICA, CALLUNA VULGARIS, FLOS, CAPSICUM ANNUUM, CAT HAIR, CHAMOMILLA, CHELIDONIUM MAJUS, CHENOPODIUM ANTHELMINTICUM, CINNAMOMUMNewton Laboratories, Inc.9d5dea47-5103-21a3-e053-2995a90aee782024-05-20WarningsExact identifier
unii: J2B2A4N98G
Amlodipine, Valsartan and HydrochlorothiazideAMLODIPINE, VALSARTAN AND HYDROCHLOROTHIAZIDEAurobindo Pharma Limited6fba5243-ee00-4825-a04a-321cb6b49c562024-05-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
bisoprolol fumarate and hydrochlorothiazideBISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDEBryant Ranch Prepack36fbc5fc-4a75-4aa3-bed1-78944135ae112024-05-17Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDENuCare Pharmaceuticals,Inc.1884db5f-72b5-6b0c-e063-6394a90a0e492024-05-15Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Losartan Potassium and HydrochlorothiazideLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEA-S Medication Solutions1bb08103-04ee-47a6-a9ad-290e169feb512024-05-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Losartan Potassium and HydrochlorothiazideLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEA-S Medication Solutionsc8740506-c679-4c41-a96a-8ddbcddd72c62024-05-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH

Reported adverse events (FAERS/openFDA)#

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