FDA.reportPublic FDA data

NDC 70518-4197-00 - 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
70518-4197-00
Package NDCs from labels
70518-4197-0, 70518-4197-1, 70518-4197-2, 70518-4197-00
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 1 of 18 · 346 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CalamineCALAMINE, PRAMOXINE HCLUnited Natural Foods, Inc. dba UNFI0bc1a9b4-1210-4d9a-bbd2-40e9225e86ea2026-09-04Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
Xtreme Saline Rinse MixSODIUM BICARBONATE, SODIUM CHLORIDEXtreme Personal Care Inc776f417e-e443-4918-8c7a-1913b7dddcd42026-09-01WarningsExact identifier
unii: 8MDF5V39QO
Enalapril MaleateENALAPRIL MALEATEREMEDYREPACK INC.3fbc6cce-7ad5-49d5-9705-5f66ef92d5442026-09-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 858817
unii: 9O25354EPJ
Enalapril MaleateENALAPRIL MALEATEREMEDYREPACK INC.5118eb9f-1466-4318-b17e-cf5898edbeef2026-08-31Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA213273
ndc (package): 70518-4197-0
ndc (package): 70518-4197-2
ndc (package): 70518-4197-1
ndc (product): 70518-4197
ndc11 (package): 70518419700
rxcui: 858817
spl id: 5a57ebd9-07fe-cfdf-e063-6294a90a98cb
spl set id: 5118eb9f-1466-4318-b17e-cf5898edbeef
unii: 9O25354EPJ
Enalapril MaleateENALAPRIL MALEATEREMEDYREPACK INC.a5c6e64c-a3ed-44f2-83e7-f4b62b6cd6222026-08-31Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA213273
rxcui: 858804
unii: 9O25354EPJ
Enalapril maleateENALAPRIL MALEATEREMEDYREPACK INC.7077d32e-4b06-4d48-ba0c-6db2f8ebe08c2026-08-28Warnings, Adverse reactionsExact identifier
rxcui: 858810
unii: 9O25354EPJ
Sodium BicarbonateSODIUM BICARBONATEREMEDYREPACK INC.96093b76-5d98-4d2b-b851-20207a8864db2026-08-28Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
CalamineFERRIC OXIDE REDYour Military Exchangesaf95a66c-f063-4019-80c6-6f7dc4fee4d82026-08-28Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
Enalapril MaleateENALAPRIL MALEATECoupler LLC59f44ba0-a323-493f-e063-6394a90a1c3c2026-08-26Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA213273
rxcui: 858804
unii: 9O25354EPJ
Calamine PlusCALAMINE, PRAMOXINE HYDROCHLORIDEKroger Company44fdd5a4-3cac-15e5-e063-6294a90adb522026-08-26WarningsExact identifier
unii: 1K09F3G675
Enalapril MaleateENALAPRIL MALEATEREMEDYREPACK INC.e47afc0d-afc4-4972-a28a-5d3c640390ab2026-08-26Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA213273
rxcui: 858810
unii: 9O25354EPJ
Sodium BicarbonateSODIUM BICARBONATEExela Pharma Sciences, LLCf8806ec3-a1c0-47a9-9660-2628dca4623e2026-08-25Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
Enalapril MaleateENALAPRIL MALEATEBryant Ranch Prepack7fdc2d8a-9b5d-43c4-b32f-6f2505aee33c2026-08-24Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 858817
unii: 9O25354EPJ
Enalapril MaleateENALAPRIL MALEATEBryant Ranch Prepackb4b7b936-4a62-4991-8d3c-03bb37f044c12026-08-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 858804
unii: 9O25354EPJ
Enalapril MaleateENALAPRIL MALEATEBryant Ranch Prepackbdb34c96-1532-4ce5-93a7-3cc90904c9102026-08-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 858813
unii: 9O25354EPJ
omeprazole and sodium bicarbonateOMEPRAZOLE, SODIUM BICARBONATEAmazon.com Services LLCbb453f26-c7df-4cce-8793-337cb5d5f9a92026-08-19WarningsExact identifier
unii: 8MDF5V39QO
sodium bicarbonateSODIUM BICARBONATEBaxter Healthcare Corporationb50c858a-00c8-4cb2-ad73-8797f19e656d2026-08-14Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
Enalapril MaleateENALAPRIL MALEATEREMEDYREPACK INC.1b464099-491d-473b-836e-9d86b2b1eeec2026-08-11Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA213273
rxcui: 858813
unii: 9O25354EPJ
Enalapril MaleateENALAPRIL MALEATEBryant Ranch Prepackfb3c7066-76cb-4e8e-b98b-bcb41a3631df2026-08-11Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 858804
rxcui: 858810
rxcui: 858817
unii: 9O25354EPJ
Sodium BicarbonateSODIUM BICARBONATEMilla Pharmaceuticals Inc.2d2035c2-e41b-4d57-a23c-fae16ad9a3552026-08-07Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO

Reported adverse events (FAERS/openFDA)#

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