FDA.reportPublic FDA data

NDC 70518-4197-01 - 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
70518-4197
Requested NDC
70518-4197-01
Package NDCs from labels
70518-4197-0, 70518-4197-1, 70518-4197-2, 70518-4197-01
Manufacturer
REMEDYREPACK INC.
Effective date
2026-08-31
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
ENALAPRIL MALEATE TABLETS Rx onlyREMEDYREPACK INC.2026-08-31HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-4197-0Enalapril Maleate90 in 1 BOTTLE, PLASTICTABLET904
70518-4197-1Enalapril Maleate30 in 1 BLISTER PACKTABLET304
70518-4197-2Enalapril Maleate90 in 1 BOTTLE, PLASTICTABLET904

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-4197ENALAPRIL MALEATE TABLET [REMEDYREPACK INC.]1Current NDC, 3 package rows20241004_5118eb9f-1466-4318-b17e-cf5898edbeef.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 17 of 17 · 336 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
rxcui: 858810
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
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.