FDA.reportPublic FDA data

NDC 51672-4045-03 - 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
51672-4045-03
Package NDCs from labels
51672-4045-1, 51672-4045-3, 51672-4045-03
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 1 of 53 · 1,049 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Triamterene and HydrochlorothiazideTRIAMTERENE AND HYDROCHLOROTHIAZIDEREMEDYREPACK INC.5ee165a3-39a4-4d12-aff2-a6fb3309ce392026-09-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Telmisartan and HydrochlorothiazideTELMISARTAN AND HYDROCHLOROTHIAZIDEAvKARE1b303136-dccd-178b-e063-6394a90a35f82026-09-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
CalamineCALAMINE, PRAMOXINE HCLUnited Natural Foods, Inc. dba UNFI0bc1a9b4-1210-4d9a-bbd2-40e9225e86ea2026-09-04Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
Triamterene and HydrochlorothiazideTRIAMTERENE AND HYDROCHLOROTHIAZIDEREMEDYREPACK INC.7dc3414b-dcb5-4b11-bca7-c0fa3f474aea2026-09-03Boxed warning, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Olmesartan Medoxomil and HydrochlorothiazideOLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEUmedica Laboratories USA Inc.55d6aee1-01ca-4791-8404-386664b4ab072026-09-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Xtreme Saline Rinse MixSODIUM BICARBONATE, SODIUM CHLORIDEXtreme Personal Care Inc776f417e-e443-4918-8c7a-1913b7dddcd42026-09-01WarningsExact identifier
unii: 8MDF5V39QO
Enalapril MaleateENALAPRIL MALEATEREMEDYREPACK INC.3fbc6cce-7ad5-49d5-9705-5f66ef92d5442026-09-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9O25354EPJ
Enalapril MaleateENALAPRIL MALEATEREMEDYREPACK INC.5118eb9f-1466-4318-b17e-cf5898edbeef2026-08-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9O25354EPJ
Enalapril MaleateENALAPRIL MALEATEREMEDYREPACK INC.a5c6e64c-a3ed-44f2-83e7-f4b62b6cd6222026-08-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9O25354EPJ
Bisoprolol Fumarate and HydrochlorothiazideBISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDEEdenbridge Pharmaceuticals LLC.295532b5-65c8-40c3-8d27-cfd334d128022026-08-28Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Enalapril maleateENALAPRIL MALEATEREMEDYREPACK INC.7077d32e-4b06-4d48-ba0c-6db2f8ebe08c2026-08-28Warnings, Adverse reactionsExact identifier
unii: 9O25354EPJ
Sodium BicarbonateSODIUM BICARBONATEREMEDYREPACK INC.96093b76-5d98-4d2b-b851-20207a8864db2026-08-28Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
olmesartan medoxomil / amlodipine besylate / hydrochlorothiazideOLMESARTAN MEDOXOMIL / AMLODIPINE BESYLATE / HYDROCHLOROTHIAZIDEREMEDYREPACK INC.57ffeef7-bfa8-4f92-aadc-23cd000226072026-08-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
CalamineFERRIC OXIDE REDYour Military Exchangesaf95a66c-f063-4019-80c6-6f7dc4fee4d82026-08-28Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
HydrochlorothiazideHYDROCHLOROTHIAZIDEREMEDYREPACK INC.f20fd735-30c7-4f89-8ceb-b6186646eea62026-08-27Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
HydrochlorothiazideHYDROCHLOROTHIAZIDEREMEDYREPACK INC.8e0683e2-5473-4246-97ae-b71c21c39ac72026-08-26Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Enalapril MaleateENALAPRIL MALEATECoupler LLC59f44ba0-a323-493f-e063-6394a90a1c3c2026-08-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9O25354EPJ
KUGIG ALOE FOAMING INTIMATE WASHINTIMATE CLEANSING FOAMHong Kong KangXing Centennial Management Limited59f4d398-1186-a168-e063-6294a90ab44b2026-08-26WarningsExact identifier
unii: 059QF0KO0R
Calamine PlusCALAMINE, PRAMOXINE HYDROCHLORIDEKroger Company44fdd5a4-3cac-15e5-e063-6294a90adb522026-08-26WarningsExact identifier
unii: 1K09F3G675
Enalapril MaleateENALAPRIL MALEATEREMEDYREPACK INC.e47afc0d-afc4-4972-a28a-5d3c640390ab2026-08-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9O25354EPJ

Reported adverse events (FAERS/openFDA)#

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