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 18 of 53 · 1,047 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sodium Bicarbonate 10 grSODIUM BICARBONATEGRAXCELL PHARMACEUTICAL, LLC897dbb09-fb47-4e03-8cae-bf76d48a7a032025-12-25WarningsExact identifier
unii: 8MDF5V39QO
Zegerid OTCOMEPRAZOLE, SODIUM BICARBONATERiley Consumer Care LLC1d764fc5-8eae-4fc9-a2e9-3f1954a3ac052025-12-24WarningsExact identifier
unii: 8MDF5V39QO
BABY ANTI MONKEY BUTT DIAPER RASHZINC OXIDE, CALAMINEClarion Brands, LLCe4424d74-f89c-5943-42e8-bf3a38e686192025-12-23WarningsExact identifier
unii: 1K09F3G675
ATACAND HCTCANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDEANI Pharmaceuticals, Inc.d91152c4-66ba-466f-b4f9-0da628d42b1d2025-12-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Candesartan Cilexetil and HydrochlorothiazideCANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDEANI Pharmaceuticals, Inc.bd8d318d-167a-4b26-935d-265dde3193de2025-12-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Lisinopril and HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDEQPharma, Inc.c80b2164-3795-6668-e053-2a95a90a4d452025-12-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Irbesartan and HydrochlorothiazideIRBESARTAN AND HYDROCHLOROTHIAZIDEAurobindo Pharma Limited466dd0d2-9815-4c3e-b66b-d0732b3ba8e92025-12-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
SODIUM BICARBONATESODIUM BICARBONATEProPharma Distribution3867f743-c2cf-a646-e063-6394a90a82e12025-12-18Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
Sterile WaterWATERProPharma Distribution386a0a2f-4ff7-f128-e063-6294a90a7d4d2025-12-18Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
After Bite AdvancedSODIUM BICARBONATETender Corporation d/b/a Adventure Ready Brands223d1de8-7940-bbdc-e063-6294a90a51d82025-12-18WarningsExact identifier
unii: 8MDF5V39QO
Irbesartan and HydrochlorothiazideIRBESARTAN AND HYDROCHLOROTHIAZIDEUnichem Pharmaceuticals (USA), Inc.181324c5-256f-4570-a0bb-8bc908deb2e22025-12-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDEA-S Medication Solutionsf9faec8a-2b71-47bb-a296-48ecbce9af502025-12-16Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Enalapril maleateENALAPRIL MALEATEWilshire Pharmaceuticals, Inc.c7934b45-eb6b-44c1-bd2c-ef0fa10850c12025-12-16Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9O25354EPJ
EpanedENALAPRIL MALEATEAzurity Pharmaceuticals, Inc.e6dbda02-779e-420c-893d-d0fea09432be2025-12-16Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9O25354EPJ
HydrochlorothiazideHYDROCHLOROTHIAZIDEQPharma, Inc.c9c44c37-bb49-4364-9293-3c8fd51b759e2025-12-16Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
INZIRQOHYDROCHLOROTHIAZIDEANI Pharmaceuticals, Inc.41aaea48-6c1b-42c8-a96f-5923d49dc9342025-12-16Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
HydrochlorothiazideHYDROCHLOROTHIAZIDEQPharma, Inc.9cd5d16e-3db7-4b25-847d-6de91543463b2025-12-15Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Exforge HCTAMLODIPINE VALSARTAN AND HYDROCHLOROTHIAZIDENovartis Pharmaceuticals Corporation18d7820d-471f-4ee2-9ec6-25d8d27c77de2025-12-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
SinuCleanseSODIUM BICARBONATE, SODIUM CHLORIDEASCENT CONSUMER PRODUCTS, INC.beb842fa-2373-4f21-9631-ef20ee1245842025-12-10WarningsExact identifier
unii: 8MDF5V39QO
All natural Saline Packets CareOneSODIUM BICARBONATE, SODIUM CHLORIDEFOODHOLD U.S.A.e32f105d-65cd-8095-e053-2995a90a9b6b2025-12-10WarningsExact identifier
unii: 8MDF5V39QO

Reported adverse events (FAERS/openFDA)#

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