FDA.reportPublic FDA data

NDC 51672-4245-01 - Enalapril Maleate

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
51672-4245
Requested NDC
51672-4245-01
Package NDCs from labels
51672-4245-1, 51672-4245-3, 51672-4245-01
Manufacturer
REMEDYREPACK INC.
Effective date
2026-09-01
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Enalapril Maleate Tablets, USPREMEDYREPACK INC.2026-09-01HUMAN PRESCRIPTION DRUG LABEL
Enalapril Maleate - Bryant Ranch PrepackBryant Ranch Prepack2026-08-24HUMAN PRESCRIPTION DRUG LABEL
Enalapril Maleate Tablets, USPGolden State Medical Supply, Inc.2026-07-28HUMAN PRESCRIPTION DRUG LABEL
Enalapril Maleate Tablets, USPSun Pharmaceutical Industries, Inc. | Taro Pharmaceuticals Industries Ltd.2026-07-14HUMAN PRESCRIPTION DRUG LABEL
Enalapril Maleate - A-S Medication SolutionsA-S Medication Solutions2023-10-02HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51672-4245-1Enalapril Maleate100 in 1 BOTTLETABLET10013
51672-4245-3Enalapril Maleate1000 in 1 BOTTLETABLET100013

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-4245ENALAPRIL MALEATE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]13Current NDC, 2 package rows20230728_f103b9f9-e081-419d-a2d8-b86acda834dd.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-4245-1EA - Each51672-42454783b04f-762e-466c-b4ab-652d8e12ddeb12023-10-16
51672-4245-3EA - Each51672-4245ed82a21e-f396-472f-886f-b1bbea41b04d12023-10-16

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Enalapril MaleateACTIVE INGREDIENT9O25354EPJENALAPRIL MALEATE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]6
Enalaprilat AnhydrousACTIVE MOIETYQ508Q118JMENALAPRIL MALEATE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]6
Ferric Oxide RedINACTIVE INGREDIENT1K09F3G675ENALAPRIL MALEATE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]6
Ferric Oxide YellowINACTIVE INGREDIENTEX438O2MRTENALAPRIL MALEATE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]6
Lactose MonohydrateINACTIVE INGREDIENTEWQ57Q8I5XENALAPRIL MALEATE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]6
Magnesium StearateINACTIVE INGREDIENT70097M6I30ENALAPRIL MALEATE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]6
Sodium BicarbonateINACTIVE INGREDIENT8MDF5V39QOENALAPRIL MALEATE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]6

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 4 of 17 · 336 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Enalapril MaleateENALAPRIL MALEATECoupler LLC508a58fa-9f66-e984-e063-6394a90a296a2026-04-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 858817
unii: 9O25354EPJ
Caldesene BabySTARCH, CORN AND ZINC OXIDEInsight Pharmaceuticals LLC9f12dee2-7afa-45e9-a729-0fd42bb777152026-04-22WarningsExact identifier
unii: O8232NY3SJ
Caldesene Medicated ProtectingCORNSTARCH AND ZINC OXIDEInsight Pharmaceuticals LLCffc92a0f-a7cf-4a46-b2f1-089df2bbb96b2026-04-22WarningsExact identifier
unii: O8232NY3SJ
Arm and Hammer Baking SodaSODIUM BICARBONATEChurch & Dwight Co., Inc.643fe204-4a7b-00e4-e053-2a91aa0aef062026-04-21WarningsExact identifier
unii: 8MDF5V39QO
SODIUM BICARBONATESODIUM BICARBONATEMedical Purchasing Solutions, LLC4f97d398-2118-0874-e063-6394a90a4ad12026-04-16Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
PEG 3350 and ElectrolytesPOLYETHYLENE GLYCOL 3350, SODIUM SULFATE ANHYDROUS, SODIUM BICARBONATE, SODIUM CHLORIDE, POTASSIUM CHLORIDEWilshire Pharmaceuticals, Inc.b251752d-7750-482a-9364-0acf4ad47cc82026-04-16Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
GoLYTELYPOLYETHYLENE GLYCOL 3350, SODIUM SULFATE ANHYDROUS, SODIUM BICARBONATE, SODIUM CHLORIDE, POTASSIUM CHLORIDEAzurity Pharmaceuticals, Inc.7609ecf7-0ce0-4fbb-9c27-30987f6895752026-04-15Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
TRILYTEPOLYETHYLENE GLYOCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE AND POTASSIUM CHLORIDEAurobindo Pharma Limited79f5e596-8d51-4227-afcc-f5e3411509572026-04-15Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
PEG 3350, sodium chloride, sodium bicarbonate and potassium chloridePOLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDEWilshire Pharmaceuticals, Inc.4e442a72-b13b-4869-8a1d-59356095b0912026-04-14Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
Sodium Bicarbonate 10 gr. (650 mg)SODIUM BICARBONATEGendose Pharmaceuticals, LLC0a0cc46d-372e-4175-932a-065e82d8d3532026-04-13WarningsExact identifier
unii: 8MDF5V39QO
Enalapril MaleateENALAPRIL MALEATEPreferred Pharmaceuticals Inc.5596ba00-4a1c-4503-99db-3a9617ed17c02026-04-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 858813
unii: 9O25354EPJ
Enalapril MaleateENALAPRIL MALEATEPreferred Pharmaceuicals Inc.898b36d6-320f-4d6c-9734-0be8363dc3d72026-04-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 858817
unii: 9O25354EPJ
Enalapril MaleateENALAPRIL MALEATEPreferred Pharmaceuticals Inc.9e277302-6e6c-4a95-8f25-aaff64fb0b822026-04-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 858810
unii: 9O25354EPJ
CalamineCALAMINE 8%, ZINC OXIDE 8%Farmacias De Similares TX LLC4ecd0add-11c9-cf3b-e063-6394a90adff62026-04-06WarningsExact identifier
unii: 1K09F3G675
Sodium BicarbonateSODIUM BICARBONATEHospira, Inc.ea9f4498-0d43-4043-8dd1-f22537841c212026-04-06Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
Sodium BicarbonateSODIUM BICARBONATEHospira, Inc.8664c7ce-707b-4c6c-9ce4-7160b5f877f82026-04-06Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
Omeprazole/BicarbonateOMEPRAZOLE AND SODIUM BICARBONATEProficient Rx LP4d642036-7175-4f29-9f07-dbd282231d4a2026-04-01Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
Rapidol Sodium BicarbonateSODIUM BICARBONATEPharmadel LLCb4c9a653-6f51-7c98-e053-2995a90ada372026-03-26WarningsExact identifier
unii: 8MDF5V39QO
Sodium Bicarbonate AntacidSODIUM BICARBONATEAphena Pharma Solutions - Tennessee, LLCbba7d5bf-c94b-4ee4-a399-9a2818d84c782026-03-23WarningsExact identifier
unii: 8MDF5V39QO
PowderTITANIUM DIOXIDEOxygen Development LLC4d3a0a92-b0de-a1ea-e063-6294a90a85082026-03-17WarningsExact identifier
unii: 1K09F3G675

Reported adverse events (FAERS/openFDA)#

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