FDA.reportPublic FDA data

NDC 51672-4038-01 - 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
51672-4038
Requested NDC
51672-4038-01
Package NDCs from labels
51672-4038-1, 51672-4038-3, 51672-4038-01
Manufacturer
Bryant Ranch Prepack
Effective date
2026-08-20
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Enalapril Maleate - Bryant Ranch PrepackBryant Ranch Prepack2026-08-20HUMAN PRESCRIPTION DRUG LABEL
Enalapril Maleate Tablets, USPGolden State Medical Supply, Inc.2026-08-05HUMAN PRESCRIPTION DRUG LABEL
Enalapril Maleate Tablets, USPSun Pharmaceutical Industries, Inc. | Taro Pharmaceuticals Industries Ltd.2026-07-14HUMAN PRESCRIPTION DRUG LABEL
Enalapril Maleate Tablets, USPPreferred Pharmaceuticals Inc.2024-04-15HUMAN PRESCRIPTION DRUG LABEL
Enalapril Maleate Tablets, USPREMEDYREPACK INC.2024-02-21HUMAN PRESCRIPTION DRUG LABEL
Enalapril Maleate - A-S Medication SolutionsA-S Medication Solutions2023-12-12HUMAN PRESCRIPTION DRUG LABEL
Enalapril Maleate - St. Mary's Medical Park PharmacySt. Mary's Medical Park Pharmacy2021-10-06HUMAN PRESCRIPTION DRUG LABEL
Enalapril Maleate - Denton Pharma, Inc. dba Northwind PharmaceuticalsDenton Pharma, Inc. dba Northwind Pharmaceuticals2020-07-07HUMAN PRESCRIPTION DRUG LABEL
Enalapril Maleate - Denton Pharma, Inc. dba Northwind PharmaceuticalsDenton Pharma, Inc. dba Northwind Pharmaceuticals2020-03-26HUMAN PRESCRIPTION DRUG LABEL
Enalapril Maleate Tablets, USPREMEDYREPACK INC.2019-09-15HUMAN PRESCRIPTION DRUG LABEL
Enalapril Maleate - DOH CENTRAL PHARMACYDOH CENTRAL PHARMACY2019-01-17HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51672-4038-1Enalapril Maleate100 in 1 BOTTLETABLET10013
51672-4038-3Enalapril Maleate1000 in 1 BOTTLETABLET100013

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-4038ENALAPRIL MALEATE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]13Current NDC, Legacy 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
51672-4038-1EA - Each51672-4038a4d72af7-6ecd-4df1-b833-43669eab8d5c12013-02-13
51672-4038-3EA - Each51672-4038687d907e-5dba-4a27-b4b7-48dc5c9a16d912013-02-13

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
Enalapril MaleateACTIVE INGREDIENT9O25354EPJENALAPRIL MALEATE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]2
ENALAPRILAT ANHYDROUSACTIVE MOIETYQ508Q118JMENALAPRIL MALEATE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675ENALAPRIL MALEATE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTENALAPRIL MALEATE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]2
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XENALAPRIL MALEATE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]2
magnesium stearateINACTIVE INGREDIENT70097M6I30ENALAPRIL MALEATE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]2
sodium bicarbonateINACTIVE INGREDIENT8MDF5V39QOENALAPRIL MALEATE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJENALAPRIL MALEATE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]2

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 16 of 18 · 343 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
N03 EXCHEMALLIUM SATIVUM, ARSENICUM ALBUM, BENZOICUM ACIDUM, BERBERIS VULGARIS, BETULA VERRUCOSA, CALCAREA CARBONICA, CARBOLICUM ACIDUM, CHELIDONIUM MAJUS, CHLORINUM, CITRICUM ACIDUM, HISTAMINUM, ICHTHYOLUM, JUNIPERUS COMMUNIS, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NATRUM BICARBONICUM, SODIUM HYPOCHLORITE, SOLIDAGO VIRGAUREA, SULPHURApex Energetics Inc.ba73a050-9a5d-1549-e053-2a95a90a62aa2024-01-08WarningsExact identifier
unii: 8MDF5V39QO
Sodium BicarbonateSODIUM BICARBONATEPharma Nobis, LLCe42f674b-1a70-6a3c-e053-2995a90afa722023-12-22WarningsExact identifier
unii: 8MDF5V39QO
HEB Extra Strength Effervescent Antacid and Pain ReliefASPIRIN, CITRIC ACID, SODIUM BICARBONATEH. E. Butt Grocery Company9e502bd0-8042-8674-e053-2995a90a3d152023-12-18WarningsExact identifier
unii: 8MDF5V39QO
Medis Sodium BicarbonateSODIUM BICARBONATEHumco Holding Group, Inc5da32469-58fc-14b1-e053-2a91aa0a74c42023-12-15WarningsExact identifier
unii: 8MDF5V39QO
Enalapril MaleateENALAPRIL MALEATEA-S Medication Solutions0ad4bfb4-62db-4759-af60-88eb031d125a2023-12-12Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA075657
ndc (package): 50090-3378-0
ndc (package): 50090-3378-3
ndc (package): 50090-3378-1
ndc (product): 50090-3378
rxcui: 858813
spl id: fc9fb737-93aa-4d2e-a840-ec662f356429
spl set id: 0ad4bfb4-62db-4759-af60-88eb031d125a
unii: 9O25354EPJ
Sodium Bicarbonate AntacidSODIUM BICARBONATERugby Laboratoriese73b5871-4a87-4473-ab00-5e5395be017d2023-12-06WarningsExact identifier
unii: 8MDF5V39QO
INONALUMINUM HYDROXIDE, MAGNESIUM CARBONATE, SODIUM BICARBONATESato Pharmaceutical Co., Ltd.e86d9c57-c877-49f1-a405-95a9a226ccf32023-12-04WarningsExact identifier
unii: 8MDF5V39QO
Sodium BicarbonateSODIUM BICARBONATEA-S Medication Solutionsd89406d3-4356-4a8c-acc1-89efe1d270102023-11-14Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
Sodium BicarbonateSODIUM BICARBONATEMedical Purchasing Solutions, LLC09cf38c2-0b44-eca1-e063-6294a90a72d82023-11-10Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
omeprazole sodium bicarbonateOMEPRAZOLE SODIUM BICARBONATECipla USA Inc.9cdde58a-ae8a-451f-92cf-cab178e4ba922023-11-01Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
Sodium BicarbonateSODIUM BICARBONATEAPNAR PHARMA LPe206c240-55c2-2d00-e053-2a95a90a17792023-10-21Boxed warning, WarningsExact identifier
unii: 8MDF5V39QO
Enalapril MaleateENALAPRIL MALEATEA-S Medication Solutionsf3754f29-9b75-4e2c-9c28-b3479f5bf9062023-10-02Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA075657
rxcui: 858817
unii: 9O25354EPJ
Omeprazole/Sodium BicarbonateOMEPRAZOLEStrides Pharma Science Limitedcf6d293e-d70d-443e-8292-d693e93aab552023-09-21Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
Sodium BicarbonateSODIUM BICARBONATEOMNIVIUM PHARMACEUTICALS LLC.aea54f8d-1cdd-4a5c-a2f7-7317ae4c8fbc2023-08-10Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
Omeprazole and Sodium BicarbonateOMEPRAZOLE AND SODIUM BICARBONATEDr. Reddy's Laboratories Inc.,c6b5f808-4a49-1303-9711-badb022ecd702023-07-19WarningsExact identifier
unii: 8MDF5V39QO
Sodium BicarbonateSODIUM BICARBONATEA-S Medication Solutions619cb558-84e5-43ea-91e9-28c764f9f9c02023-06-21Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
PEG-3350 and ElectrolytesPOLYETHYLENE GLYCOL 3350, SODIUM SULFATE ANHYDROUS, SODIUM BICARBONATE, SODIUM CHLORIDE, POTASSIUM CHLORIDEA-S Medication Solutions7a2d8dab-750f-43c1-933c-4169a840c60c2023-06-20Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
Enalapril MaleateENALAPRIL MALEATEA-S Medication Solutions7b80abb4-fa75-48a4-a2e9-b0e31205234c2023-05-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 858813
unii: 9O25354EPJ
Sodium BicarbonateSODIUM BICARBONATEMedical Purchasing Solutions, LLCb620938d-ab2d-0934-e053-2a95a90a84832023-05-23Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
Sodium BicarbonateSODIUM BICARBONATEMedical Purchasing Solutions, LLCd1636b56-ad83-4439-e053-2a95a90a135e2023-05-02Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO

Reported adverse events (FAERS/openFDA)#

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