FDA.reportPublic FDA data

NDC 51672-4040-01 - 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
51672-4040
Requested NDC
51672-4040-01
Package NDCs from labels
51672-4040-1, 51672-4040-3, 51672-4040-01
Manufacturer
Bryant Ranch Prepack
Effective date
2026-08-11
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 Prepack2026-08-11HUMAN 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 - A-S Medication SolutionsA-S Medication Solutions2026-01-06HUMAN PRESCRIPTION DRUG LABEL
Enalapril Maleate - Northwind Health Company, LLCNorthwind Health Company, LLC2026-01-01HUMAN PRESCRIPTION DRUG LABEL
Enalapril Maleate - Bryant Ranch PrepackBryant Ranch Prepack2024-04-03HUMAN PRESCRIPTION DRUG LABEL
Enalapril Maleate Tablets, USPREMEDYREPACK INC.2024-01-03HUMAN PRESCRIPTION DRUG LABEL
Enalapril Maleate - Denton Pharma, Inc. DBA Northwind PharmaceuticalsDenton Pharma, Inc. DBA Northwind Pharmaceuticals2023-01-01HUMAN PRESCRIPTION DRUG LABEL
Enalapril Maleate - Denton Pharma, Inc. dba Northwind PharmaceuticalsDenton Pharma, Inc. dba Northwind Pharmaceuticals2020-07-08HUMAN PRESCRIPTION DRUG LABEL
Enalapril Maleate - Proficient Rx LPProficient Rx LP2020-03-01HUMAN PRESCRIPTION DRUG LABEL
Enalapril Maleate Tablets, USPBlenheim Pharmacal, Inc.2015-02-19HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51672-4040-1Enalapril Maleate100 in 1 BOTTLETABLET10013
51672-4040-3Enalapril Maleate1000 in 1 BOTTLETABLET100013

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-4040ENALAPRIL 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
51672-4040-1EA - Each51672-40404dcf6987-7ffe-465e-b63f-32804931974212013-02-13
51672-4040-3EA - Each51672-40400657f60b-0138-4b94-87cc-45e8b0517f4f12013-02-13

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
ENALAPRIL MALEATEACTIVE INGREDIENT9O25354EPJENALAPRIL MALEATE TABLET [BLENHEIM PHARMACAL, INC.]1
ENALAPRILAT ANHYDROUSACTIVE MOIETYQ508Q118JMENALAPRIL MALEATE TABLET [BLENHEIM PHARMACAL, INC.]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675ENALAPRIL MALEATE TABLET [BLENHEIM PHARMACAL, INC.]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTENALAPRIL MALEATE TABLET [BLENHEIM PHARMACAL, INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XENALAPRIL MALEATE TABLET [BLENHEIM PHARMACAL, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ENALAPRIL MALEATE TABLET [BLENHEIM PHARMACAL, INC.]1
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QOENALAPRIL MALEATE TABLET [BLENHEIM PHARMACAL, INC.]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 17 of 17 · 340 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
POLYETHYLENE GLYCOL-3350 AND ELECTROLYTESPOLYETHYLENE GLYCOL-3350 AND ELECTROLYTESNovel Laboratories, Inc.29d821ff-389c-41fb-8a27-89bd3f022b822023-02-08Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
f186bdc1-db6a-0fab-e053-2995a90a7c58a9f27b51-5710-13d4-e053-2a95a90a54352023-01-05Boxed warning, Warnings, Adverse reactionsExact identifier
spl set id: a9f27b51-5710-13d4-e053-2a95a90a5435
d167f395-73bb-da04-e053-2995a90a0385a839e6df-7003-8e6a-e053-2995a90a75362023-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
spl id: d167f395-73bb-da04-e053-2995a90a0385
spl set id: a839e6df-7003-8e6a-e053-2995a90a7536
Omeprazole, Sodium bicarbonateOMEPRAZOLE, SODIUM BICARBONATEGuardian Drug Companye5c6c2cf-fb3b-456a-a0a0-be396d6f83192022-11-08Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
Enalapril maleate oral solutionENALAPRIL MALEATECamber Pharmaceuticals, Inc.b63bdaa6-b57b-417b-9a79-29f1fd5bbf082022-02-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9O25354EPJ
Sodium BicarbonateSODIUM BICARBONATEInternational Medication Systems, Limited77698221-a01d-4568-a7bc-d3d4e982875d2021-12-15Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
8.4% SODIUM BICARBONATE8.4% SODIUM BICARBONATEHF Acquisition Co. LLC, DBA HealthFirst74d8bb7a-9e7a-105f-e053-2a91aa0aec922021-05-03Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
SODIUM BICARBONATESODIUM BICARBONATEMedical Purchasing Solutions, LLCbfc9c321-665c-ca97-e053-2995a90a79542021-04-12Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
Enalapril MaleateENALAPRIL MALEATEOCEANSIDE PHARMACEUTICALSebd2a62d-a704-4f8a-a104-749a5296502f2020-12-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 858804
rxcui: 858810
rxcui: 858817
rxcui: 858813
unii: 9O25354EPJ
Good Sense Omeprazole and Sodium BicarbonateOMEPRAZOLE, SODIUM BICARBONATEL. Perrigo Companybcf32242-de17-4da1-b707-4ce26262eb782020-11-16WarningsExact identifier
unii: 8MDF5V39QO
VasereticENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDEBausch Health US, LLCbf3007e2-8fcc-48de-8fd5-55e95033d62f2020-08-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9O25354EPJ
Enalapril MaleateENALAPRIL MALEATEProficient Rx LPca1d0143-bbd3-4041-9981-eadbb8893a2b2020-03-01Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA075657
ndc (package): 63187-977-30
ndc (package): 63187-977-60
ndc (package): 63187-977-90
ndc (product): 63187-977
rxcui: 858810
spl id: 386e877f-e67d-4f4a-964d-ca85afc1ba32
spl set id: ca1d0143-bbd3-4041-9981-eadbb8893a2b
unii: 9O25354EPJ
Enalapril MaleateENALAPRIL MALEATEProficient Rx LPcc921315-8da1-487c-ba19-433470f5c8d82019-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 858817
unii: 9O25354EPJ
Enalapril MaleateENALAPRILAmneal Pharmaceuticals NY LLCe81a8aca-0e7c-4a02-b596-09e4ac22c70e2019-03-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9O25354EPJ
SODIUM BICARBONATESODIUM BICARBONATEAphena Pharma Solutions - Tennessee, LLC15605a6d-6c90-47d5-9d1f-f66a3f27d5fc2017-12-13WarningsExact identifier
unii: 8MDF5V39QO
Sodium Bicarbonate AntacidSODIUM BICARBONATERichmond Pharmaceuticals, Inc.e0b2f0d3-3849-4bdf-b3d4-e14e520e36ce2017-11-01WarningsExact identifier
unii: 8MDF5V39QO
SODIUM BICARBONATESODIUM BICARBONATERichmond Pharmaceuticals, Inc.fa10d93d-b3ed-4675-a117-f573d9e72bca2017-10-30WarningsExact identifier
unii: 8MDF5V39QO
Sodium BicarbonateSODIUM BICARBONATEExela Pharma Sciences, LLCe9698a4f-1a95-4f28-a945-e8009d1d6dd42017-09-27Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
0f7c3734-e05c-7082-e054-00144ff88e880f7c3734-e05b-7082-e054-00144ff88e882015-02-19Boxed warning, Warnings, Adverse reactionsExact identifier
spl id: 0f7c3734-e05c-7082-e054-00144ff88e88
spl set id: 0f7c3734-e05b-7082-e054-00144ff88e88
Enalapril maleate and hydrochlorothiazideENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDEDr. Reddy's Laboratories Limiteded4a55a6-cd6a-c74a-cb93-4b45641691a02010-10-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9O25354EPJ

Reported adverse events (FAERS/openFDA)#

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