FDA.reportPublic FDA data

NDC 51672-4045-01 - 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
51672-4045
Requested NDC
51672-4045-01
Package NDCs from labels
51672-4045-1, 51672-4045-3, 51672-4045-01
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51672-4045-1Enalapril Maleate and Hydrochlorothiazide100 in 1 BOTTLETABLET10012
51672-4045-3Enalapril Maleate and Hydrochlorothiazide1000 in 1 BOTTLETABLET100012

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-4045ENALAPRIL 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
51672-4045-1EA - Each51672-404565069710-3c5b-4339-ba87-09ceb26cf72012012-07-24

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

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 39 of 52 · 1,028 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
Triamterene and HydrochlorothiazideTRIAMTERENE AND HYDROCHLOROTHIAZIDEActavis Pharma, Inc.abf2fe45-8b69-4d3c-981e-289c0aa3e98b2024-05-01Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Losartan Potassium and HydrochlorothiazideLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEProficient Rx LPc6ed6f74-0eca-4f99-8c7e-dd3f56167f012024-05-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Fosinopril Sodium and HydrochlorothiazideFOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDEAurobindo Pharma Limited35019655-9a30-4305-a262-936ad0e730712024-04-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
QUINAPRIL HYDROCHLORIDE/HYDROCHLOROTHIAZIDEQUINAPRIL HYDROCHLORIDE/HYDROCHLOROTHIAZIDEAurobindo Pharma Limited50a58159-9572-4445-9859-b392632597da2024-04-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
HydrochlorothiazideHYDROCHLOROTHIAZIDEA-S Medication Solutions98a58b54-bcf2-4726-800a-facf48d9155f2024-04-25Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
PEMF OptimizerAQUA SULIS, ARGENTUM METALLICUM, AURUM METALLICUM, CUPRUM METALLICUM, LAPIS ALBUS, MANGANUM METALLICUM VANADIUM METALLICUM VISCUM ALBUM, ZINCUM METALLICUMDeseret Biologicals, Inc.97d57469-4c5b-4d3f-9398-3a1a6617a6492024-04-23WarningsExact identifier
unii: 059QF0KO0R
Enalapril maleate oral solutionENALAPRIL MALEATENorthStar RxLLC19606da3-c6b0-40a5-9690-77fc37072b512024-04-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9O25354EPJ
Triamterene and HydrochlorothiazideTRIAMTERENE AND HYDROCHLOROTHIAZIDENuCare Pharmaceuticals,Inc.cba87d5b-9302-7b2c-e053-2a95a90a7f9d2024-04-17Boxed warning, Adverse reactionsExact identifier
unii: 0J48LPH2TH
hydrochlorothiazideHYDROCHLOROTHIAZIDEA-S Medication Solutions39d4dbd3-8f24-4898-a240-e94e06fa229a2024-04-11Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Sterile WaterWATERHikma Pharmaceuticals USA Inc.78ef7ad3-451d-43d0-a9b6-5cf0aadca0032024-04-10Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDEOLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEA-S Medication Solutions4c0b028d-f0f4-417f-a068-dca24e56113f2024-04-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Sterile WaterWATERB. Braun Medical Inc.8fc8d87a-3951-4ac5-97df-c161ffc904752024-04-10Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
olmesartan medoxomil / amlodipine besylate / hydrochlorothiazideOLMESARTAN MEDOXOMIL / AMLODIPINE BESYLATE / HYDROCHLOROTHIAZIDEBryant Ranch Prepacka6ebafdc-4301-4d6c-b578-b3212648b13a2024-04-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Triamterene and HydrochlorothiazideTRIAMTERENE AND HYDROCHLOROTHIAZIDEBryant Ranch Prepack5ca13106-f68b-4894-aca2-03e74fff350c2024-04-03Boxed warning, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Enalapril MaleateENALAPRIL MALEATEBryant Ranch Prepack2061543d-67e7-46b6-aa56-cafa11ae4b932024-04-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9O25354EPJ
Eye WashWATERM-star (Hubei) Health&Care Products Co., Ltd.71706039-e250-4f08-9687-71b2928c4e462024-04-01WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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