FDA.reportPublic FDA data

NDC 68071-3408-01 - 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
68071-3408
Requested NDC
68071-3408-01
Package NDCs from labels
68071-3408-1, 68071-3408-01
Manufacturer
NuCare Pharmaceuticals,Inc.
Effective date
2025-01-02
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
ENALAPRIL MALEATE TABLETS Rx onlyNuCare Pharmaceuticals,Inc.2025-01-02HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-3408-1Enalapril Maleate100 in 1 BOTTLETABLET1002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-3408ENALAPRIL MALEATE TABLET [NUCARE PHARMACEUTICALS,INC.]2Current NDC, 1 package rows20250104_fe2dfa84-0276-6603-e053-6394a90af8ee.zip

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 2 of 14 · 276 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Enalapril MaleateENALAPRIL MALEATEGolden State Medical Supply, Inc.074fe718-88d8-365c-e063-6394a90a299d2026-07-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 858817
unii: 9O25354EPJ
DERMFREE INSECT BITE RELIEFSODIUM BICARBONATE 5% INSECT BITE RELIEFWenzhou Yuyuan Pharmaceutical Co., Ltd.5794886c-0d74-9f35-e063-6394a90a27d82026-07-27WarningsExact identifier
unii: 8MDF5V39QO
PEG 3350 and ElectrolytesPOLYETHYLENE GLYCOL 3350, SODIUM SULFATE ANHYDROUS, SODIUM BICARBONATE, SODIUM CHLORIDE, POTASSIUM CHLORIDEA-S Medication Solutions19daf830-7270-4661-81b1-ded38f867f282026-07-24Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
ENALAPRIL MALEATEENALAPRIL MALEATEPreferred Pharmaceuticals Inc.b31372f7-cda3-4ead-a481-4cde62e843fd2026-07-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 858813
unii: 9O25354EPJ
Enalapril MaleateENALAPRIL MALEATESun Pharmaceutical Industries, Inc.f103b9f9-e081-419d-a2d8-b86acda834dd2026-07-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 858804
rxcui: 858810
rxcui: 858817
rxcui: 858813
unii: 9O25354EPJ
Enalapril Maleate and HydrochlorothiazideENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDESun Pharmaceutical Industries, Inc.7cb92cf2-46f2-4379-937c-168d230e43a42026-07-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9O25354EPJ
ENALAPRIL MALEATEENALAPRIL MALEATEPreferred Pharmaceuticals Inc.eee8633b-9d9e-453d-8c6b-8b13c94d2f582026-07-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 858810
unii: 9O25354EPJ
Sodium BicarbonateSODIUM BICARBONATEAmneal Pharmaceuticals Private Limitedac91e834-e693-43a2-829b-56793453e8cc2026-07-09Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
SODIUM BICARBONATESODIUM BICARBONATEHF Acquisition Co LLC, DBA HealthFirst9ee46a5b-d00e-4254-e053-2995a90aeb3a2026-06-29Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
ENALAPRIL MALEATEENALAPRIL MALEATEScieGen Pharmaceuticals, Inc.63187a94-9ac7-4320-ac70-0631e08c2b8d2026-06-25Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 858804
rxcui: 858810
rxcui: 858817
rxcui: 858813
unii: 9O25354EPJ
Enalapril MaleateENALAPRIL MALEATESt. Mary's Medical Park Pharmacyed266486-e4a5-9dd1-e053-2a95a90a80d32026-06-22Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA213273
rxcui: 858810
unii: 9O25354EPJ
Enalapril Maleate Oral SolutionENALAPRIL MALEATE ORAL SOLUTIONAscend Laboratories, LLC964d561a-2e04-4ad9-9762-932419ee19ae2026-06-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9O25354EPJ
SODIUM BICARBONATESODIUM BICARBONATEHF Acquisition Co LLC, DBA HealthFirstd8516f38-6f92-32d1-e053-2995a90a96bf2026-06-19Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
Sodium BicarbonateSODIUM BICARBONATE, INJECTIONCivica, Inc.3737e5e5-2296-4a3d-b8f1-dfea1eff19272026-06-15Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
E-Z-GAS IIANTACID/ANTIFLATULENTE-Z-EM, INC.4e12e1cb-b033-076d-e054-00144ff8d46c2026-06-15WarningsExact identifier
unii: 8MDF5V39QO
Sodium BicarbonateSODIUM BICARBONATECardinal Health 107, LLC60c2a176-8854-4479-b853-d07fe9a1830c2026-06-12WarningsExact identifier
unii: 8MDF5V39QO
SODIUM BICARBONATESODIUM BICARBONATEMedical Purchasing Solutions, LLC.5401e4ff-aa7a-3e97-e063-6294a90a24f02026-06-11Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
Sodium BicarbonateSODIUM BICARBONATEExela Pharma Sciences, LLC2f05947f-a489-4298-a871-90db75b2a6c52026-06-09Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
Sodium Bicarbonate AntacidSODIUM BICARBONATENCS HealthCare of KY, LLC dba Vangard Labsfde4ea0c-152b-4b79-a6d8-2b0dbd9107aa2026-06-04WarningsExact identifier
unii: 8MDF5V39QO
ENALAPRIL MALEATEENALAPRIL MALEATEBryant Ranch Prepackc1e4cd79-ece5-432c-bd3a-ed4633ccec702026-05-27Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 858817
unii: 9O25354EPJ

Reported adverse events (FAERS/openFDA)#

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