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 43 of 52 · 1,028 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sodium BicarbonateSODIUM BICARBONATEA-S Medication Solutionsd89406d3-4356-4a8c-acc1-89efe1d270102023-11-14Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
HydrochlorothiazideHYDROCHLOROTHIAZIDEBryant Ranch Prepack5de62aee-f3cc-4aaa-8588-2aed2bdeced92023-11-14Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Sodium BicarbonateSODIUM BICARBONATEMedical Purchasing Solutions, LLC09cf38c2-0b44-eca1-e063-6294a90a72d82023-11-10Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
Lisinopril and HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETSBryant Ranch Prepack5885b1ff-715c-4f90-b43d-bddf94d61acd2023-11-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
HydrochlorothiazideHYDROCHLOROTHIAZIDEA-S Medication Solutions94cd40a1-65bc-4b1b-bb05-cec93bc965022023-11-01Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
omeprazole sodium bicarbonateOMEPRAZOLE SODIUM BICARBONATECipla USA Inc.9cdde58a-ae8a-451f-92cf-cab178e4ba922023-11-01Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
Lisinopril and HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETSBryant Ranch Prepack1990af86-e9ec-48b8-b354-8456d6d80e0a2023-11-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Triamterene and HydrochlorothiazideTRIAMTERENE AND HYDROCHLOROTHIAZIDEViona Pharmaceuticals Inc9925ab75-e3b7-43b7-888e-a2c8763240ba2023-10-31Boxed warning, Adverse reactionsExact identifier
unii: 0J48LPH2TH
VALSARTAN AND HYDROCHLOROTHIAZIDEVALSARTAN AND HYDROCHLOROTHIAZIDEA-S Medication Solutions3131809e-885a-42d3-b6ad-1b208fd3ba562023-10-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Valsartan and HydrochlorothiazideVALSARTAN AND HYDROCHLOROTHIAZIDEA-S Medication Solutions89ce2fb1-330c-45f9-bd37-b402feea93782023-10-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
triamterene and hydrochlorothiazideTRIAMTERENE AND HYDROCHLOROTHIAZIDEA-S Medication Solutions27b8f965-d73f-411c-aae6-bcae6e2811132023-10-23Boxed warning, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Sodium BicarbonateSODIUM BICARBONATEAPNAR PHARMA LPe206c240-55c2-2d00-e053-2a95a90a17792023-10-21Boxed warning, WarningsExact identifier
unii: 8MDF5V39QO
HydrochlorothiazideHYDROCHLOROTHIAZIDENCS HealthCare of KY, LLC dba Vangard Labsd6b933c6-f5f8-406a-84d6-b22c6040482a2023-10-19Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
HydrochlorothiazideHYDROCHLOROTHIAZIDEBryant Ranch Prepack24cba606-263f-46dc-a4dc-fddc729c0f4b2023-10-18Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Enalapril MaleateENALAPRIL MALEATEA-S Medication Solutionsf3754f29-9b75-4e2c-9c28-b3479f5bf9062023-10-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9O25354EPJ
HydrochlorothiazideHYDROCHLOROTHIAZIDEProficient Rx LP9dd2f58b-d143-4d0c-a298-6d9390e6187a2023-10-01Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Benazepril Hydrochloride and HydrochlorothiazideBENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDEGlenmark Pharmaceuticals Inc., USA51b0aed8-a229-4d2c-8fdf-aa957fddc41b2023-09-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Omeprazole/Sodium BicarbonateOMEPRAZOLEStrides Pharma Science Limitedcf6d293e-d70d-443e-8292-d693e93aab552023-09-21Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
Olmesartan Medoxomil and HydrochlorothiazideOLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEA-S Medication Solutionsba452478-f40c-446e-b61d-388379a55efd2023-09-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Telmisartan and HydrochlorothiazideTELMISARTAN AND HYDROCHLOROTHIAZIDEAlembic Pharmaceuticals Inc.e80f232c-c1c4-4524-a0a5-d23ee0d1f3b72023-09-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH

Reported adverse events (FAERS/openFDA)#

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